[c09aa8]: / clusters / 3009knumclusters / clust_170.txt

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Treatment with any other investigational agent within 4 weeks (or within five half-lives of the investigational product, whichever is shorter) prior to cycle 1, day 1 (minimum of 1 week between prior therapy and study enrollment); patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the coordinating center PI’s discretion, and should have recovered to eligibility levels from any toxicities
Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
Must not have received investigational therapy within 30 days of entry onto this study
Current or past participation in a study of an investigational agent or using an investigational device within four weeks of registration for protocol therapy
Received systemic anticancer therapy or an investigational agent <2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ?5 half-lives of the investigational agent has elapsed.
Participants should not have received any other investigational agents nor have participated in an investigational trial within the past 4 weeks
The patient has received any investigational therapy within 4 weeks of enrollment
Receipt of systemic anticancer therapy, including investigational agents, within 5 times the agent's elimination half-life of starting study treatment
Use of investigational cancer agents within 6 weeks prior to diagnosis
The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
Use of any investigational product within 4 weeks prior to randomization
No treatment with any other type of investigational agent =< 4 weeks before pre-registration
Patients must not receive any other investigational agents while on study or within four weeks prior to registration
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Patients who are receiving any other investigational agent(s)
No investigational agent within 21 days prior to registration
Treatment with any other investigational agent within 4 weeks prior to randomization
No investigational therapy within 14 days prior to registration
Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm
Use of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment.
Participation in another clinical study with an investigational product during the 21 days prior to first dose of olaparib and temozolomide
Participants who are currently receiving any other investigational agents; treatment with an investigational agent within 2 weeks prior to planned initiation of study therapy is allowed provided that any drug-related toxicity has completely resolved
Any prior treatment with any investigational drug within the preceding 4 weeks
Subject has received other investigational therapy within the last 28 days.
Treatment with another investigational agent under the following conditions:
Concomitant treatment with another investigational agent while participating this trial.
Previous treatment with any other investigational agent in the 4 weeks prior to study drug administration (Cycle 1 Day 1)
Concurrent enrollment in another clinical study or receipt of an investigational product within the last 4 weeks (participation in the survival follow-up period of a study is not an exclusion criterion)
Patients who are receiving any other concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy as defined as treatment for which there is currently no regulatory authority approved indication) will not be eligible
Investigational agents from previous clinical study within 4 weeks
Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s).
Biologic or investigational agent (anti-neoplastic): patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent >= 7 days prior to study enrollment\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
Participation in another therapeutic clinical study or receiving any investigational agent within 28 days of enrollment or during this clinical study
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Receipt of investigational treatment within 3 weeks of scheduled Cycle 1 Day 1 (C1D1) dosing.
Use of any investigational drug within the past 4 weeks
Prior treatment with any investigational drug within the preceding 2 weeks
Treatment with investigational therapy within 14 days prior to Cycle 1, Day 1
Cohort B Safety Run-In (Ribociclib + PDR001 + Fulvestrant): Prior biologics / investigational therapy: \r\n* Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= 21 days prior to first dose of study treatment
Cohort A Dose Expansion (Ribociclib + PDR001): Prior biologics / investigational therapy: \r\n* Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= 21 days prior to first dose of study treatment
Expansion Cohort B (Ribociclib + PDR001 + Fulvestrant): Prior biologics / investigational therapy:\r\n* Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= 21 days prior to first dose of study treatment
Participants cannot have been treated on a prior interventional, investigational study within 2 weeks of the first dose of study treatment
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
No chemotherapy, other investigational agents within 14 days of study treatment
Subjects currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent
Investigational treatment - 4 weeks
Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
Patients who are currently receiving any other investigational agent
Treatment with investigational therapy within 30 days prior to initiation of study treatment
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
Treatment with an investigational agent within 4 weeks of the first dose of treatment
The subject has received another investigational agent within 21 days of the first dose of study drug
Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment.
Patient is currently receiving or has received another investigational agent within 4 weeks prior to day 1 of study
Subject has a known sensitivity to any of the components of the investigational product AGS62P1:
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Patients may not be receiving any other concurrent investigational agents, or have received any investigational agent within four weeks of commencing this protocol.
Patients who are currently receiving another investigational agent are excluded
Patients being treated with any other experimental agents/clinical trials are not eligible for participation; if the patient is on any investigational agent, a wash-out period of minimum 2 weeks prior to registration is mandatory for the patient to be eligible for the study
Participation in a clinical trial in which the patient received an investigational drug or device must be discontinued at enrollment.
SAFETY RUN-IN: Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study
Known or suspected allergy to the investigational agent or any agent given in association with this trial.
Other investigational treatment during or within 30 days before starting study registration
Current or planned participation in a study of an investigational agent or using an investigational device
Research participants receiving any other anticancer or investigational drug therapy
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to Day 1 of the study.
Systemic therapy (standard or an investigational or biological anticancer agent)
Prior treatment with any investigational drug within the preceding 2 weeks
Patients who are participating in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of registration and throughout the duration of this trial are not eligible
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other investigational agent(s) within 21 days prior starting to study treatment.
Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) or receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
Exposure to any other investigational agent at any time within 4 weeks before the first dose of study treatment
Patients may not be receiving any other investigational agent
Use of other investigational drugs at the time of screening or within the last 30 days.
Current or anticipated use of other investigational agents during the study
Participation in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug or device
Patients must not have ongoing treatment with any other investigational agents =< 14 days prior to registration
Treatment with any investigational agent within 4 weeks prior to baseline
Patients must not have received an investigational drug within 14 days
Prior investigational therapy (medications or devices) within 6 weeks of treatment.
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Are currently enrolled in, or have discontinued within 30 days of screening, from a clinical trial involving an investigational product or non-approved use of a drug or device.
Current enrollment in any other investigational treatment study
Current use or history of receiving a non-approved, investigational treatment within 14 days prior to cycle 1 day 1 of protocol therapy
Participation in a study of an investigational agent or device within 4 weeks of Day
Currently receiving any other investigational agent or received an investigational agent within last 30 days of study entry.
Treatment with any other investigational agent within 3 weeks prior to cycle 1, day 1
Use of any investigational agent within 28 days prior to randomization.
Treatment with investigational therapy within 14 days prior to initiation of study treatment
Participation in any study involving administration of an investigational agent within 30 days of randomization into this study
Participants may not be receiving treatment with any investigational drug or biologic within 30 days of randomization or at any time during the study.
Received another investigational agent within 30 days of enrollment
Prior participant in another protocol using an investigational agent within 5 half-lives of the investigational agent
Received an investigational agent within 30 days prior to enrollment
Received an investigational agent for any indication within 30 days prior to first treatment.
Subjects on treatment with chemotherapy or any investigational therapeutic agent will need to discontinue therapy 4 weeks prior to registration (wash out period)
Treatment with any therapeutic investigational agent within 28 days prior to study registration.
Investigational therapy within 4 weeks of planned randomization
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
The participant has received any other type of investigational agent within 28 days before the first dose of study treatment
Use of investigational agent within 28 days prior to randomization
Use of an investigational small molecule drug during the 30 days prior to screening or use of an investigational oligonucleotide or biologic drug during the prior 90 days
Patients who are receiving any other investigational or chemotherapeutic agents will be excluded; please contact the study principal investigator (PI) if a patient has received an investigational or chemotherapeutic agent in the past
Administration of an investigational therapeutic agent within 28 days of Cycle 1, Day 1
Investigational Drugs\r\n* Patients who are currently receiving another investigational drug are not eligible\r\n* Prior treatment with another investigational drug
Patients must not have received treatment with any chemotherapy, immunotherapy, radiotherapy or an investigational agent for malignancy within the 28 days preceding study registration; patients may not have received treatment with nitrosoureas or mitomycin within the 42 days prior to study registration; patients may not have received treatment with a small molecule targeted agent (including off-label or investigational use) within 14 days preceding study registration, provided this represents at least 7 half-lives for that agent; toxic effects from any prior therapy (except alopecia) must have resolved to grade 1 or less according to National Cancer Institute (NCI) CTCAE version (v)4.0 or to the patient’s baseline by the time of registration
Participants is taking another investigational agent
Treatment within 30 days prior to randomization with another investigational device or drug study (ies).
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with any investigational agent or approved therapy within 28 days
Agree to use condoms until 30 days following the last dose of investigational product, or
Have received prior treatment with any investigational drug within 4 weeks prior to dose assignment
Have participated, within the last 28 days in a clinical trial involving an investigational product or are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Receiving an investigational GVHD treatment within 28 days of study entry.
Patient is currently receiving or has received another investigational agent within 4 weeks prior to study day 1
Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks
Participation in another clinical study with an investigational product during the last 30 days
Any investigational agents or drugs from a previous clinical study within 28 days
Current or anticipated use of other investigational agents or marketed anticancer agent while on study
Received an investigational agent within 30 days prior to starting study treatment
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the day of dosing with the PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
The patient has received treatment with an investigational systemic anticancer agent within 28 days prior to C1D1.
The patient has previously received treatment with SL-801 or another investigational agent that inhibits the XPO1/CRM1 pathway.
Receiving other investigational agent concomitantly
Current enrollment in another clinical study involving treatment and/or is receiving an investigational agent for any reason, or use of any investigational agents within 14 days of initiating study treatment.
Investigational Drugs: Subjects who have received another investigational drug within the last 14 days are excluded from participation.
Treatment with any investigational drug 30 days prior to randomization
Prior participation in an investigational study within 21 days of study day 1
Other investigational therapy: at least two weeks since any other investigational therapy
Subject has received treatment with any investigational immunotherapy within 2 years prior to study screening or has received treatment with any other investigational product within 28 days prior to study screening
Treatment with an investigational agent within 4 weeks of registration
Subject who has been treated with an investigational product and has not completed the entire follow-up period for that investigational product;
Investigational therapy within 28 days prior to initiation of study treatment
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
Receiving any other investigational agent that would be considered as a treatment for the lymphoma
Patients who had therapy with one of the investigational agents more than 1 month prior to enrollment in whom tumor genotyping show assignment to the same investigational agent
Patient has received an investigational drug within 14 days of enrollment
Biologic therapy: patients should have received their last dose of biologic agent >= 7 days prior to enrollment; in the event the patient has received another biologic agent and has experienced >= grade 2 myelosuppression, then at least three (3) weeks must have elapsed prior to enrollment; if the investigational or biologic agent has a prolonged half-life then at least three (3) weeks interval is required
Patients who are currently receiving another investigational agent are excluded
Any other investigational drug within 30 days prior to registration and during the study
Treatment with any investigational product within 28 days prior to Screening.
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study drug
Prior treatment with any investigational drug within the preceding 4 weeks
Other investigational drugs or investigational therapy if the patient is currently taking those drugs/therapy, or if they have received the drugs/therapy within 1 month.
Plans to initiate treatment with an investigational agent during the study
Have taken an investigational agent within 30 days of visit 1
Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization
Participation in clinical trials with other investigational agents not included in this trial, =< 30 days prior to registration
Participation in any investigational drug study within 4 weeks preceding enrollment
Use of any standard chemotherapy or other investigational agent(s) within 1 week of study enrollment
Received an investigational agent within 30 days prior to enrollment
Has received treatment with any investigational drug in the previous 4 weeks
Treatment with any investigational compound within 30 days prior to the first dose of study drugs
Participation in any other clinical trials with other investigational agents not included in this trial ? 21 days prior to registration
Investigational drug therapy outside of this trial during or within 3 weeks prior to C1D1.
Patients receiving investigational agent within 30 days of enrollment. However, the principal investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of alpha-1-antitrypsin.
Received an investigational agent within 30 days prior to enrollment
The patient has received any investigational drug within the past 4 weeks
Treatment with any investigational drug within 30 days prior to registration.
Taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
Investigational drug use within 28 days of C1D1
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Any investigational drug within 28 days prior to study treatment.
Current or planned participation in a study of another investigational agent or using an investigational device.
Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents
Treatment with any investigational agent within 14 days of first administration of study treatment is not permitted
Received an investigational agent within 30 days prior to enrollment
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug
Patients who have received any other investigational agents within the past 28 days prior to cycle 1 day 1
Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
Patient is currently using, or planning to use another investigational agent
Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Patients receiving other investigational immunotherapy or anti-myeloma drugs within 14 days before enrollment.
Concomitant use of any anticancer therapy or use of any investigational agent(s).
Any other anti cancer agents (eg, hormonal, biological, investigational) within 5 times the half life prior to investigational product.
Use of any other investigational agents within 30 days of starting study treatment
Patients who have been treated with an investigational agent within 21 days prior to the first dose of study drug.
Treatment with investigational therapy within 28 days prior to randomisation
Planned participation in another study of an investigational agent or investigational device or planned use of any other agent or therapeutic device intended for therapy of glioma
Use of an investigational agent within 4 weeks of enrollment (day 1)
Administration of investigational agents within 28 days prior to treatment initiation
Receiving any approved or investigational anti-cancer agent other than those provided for in this study
Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study entry Note: Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
Patient is using or plans to use an investigational agent for the prevention of GvHD.
Plan to be included into another interventional investigational study.
Received an investigational agent within 30 days prior to enrollment
Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
Currently receiving or have received any other investigational agent considered as a treatment for the primary neoplasm =< 21 days prior to registration
The participant has received another investigational agent within 14 days of the first dose of study drug
Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs
The use of another investigational drug within the previous 30 days
Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half lives before enrollment or is currently enrolled in the treatment stage of an investigational study
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Current or planned participation in a study of an investigational agent or using an investigational device
Exposure to any investigational drug or placebo within 4 weeks of enrollment
Subjects may not be receiving any other investigational agents or have participated in any other clinical trial involving another investigational agent for treatment of advanced solid tumors or lymphoma within 3 weeks prior to cycle 1, day 1 of the study.
Participants who are receiving an investigational agent(s)
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 21 days prior to registration
Treatment with any investigational agent on a different clinical trial within 30 days of enrollment
Treatment with any investigational agent on a different clinical trial within 30 days of lymphodepleting chemotherapy
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm or used an investigational device =< 4 weeks from registration
Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
Prior BCMA-directed investigational agents at any time
No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy
Subjects who anticipate use of other investigational or non-investigational agents for the treatment of MDS during the study period, aside from a stable dose of erythropoietin stimulating agent started >8 weeks prior to screening for this study.
Treatment with any investigational agent within 28 days of first administration of study treatment.
Myelosuppressive chemotherapy, immunotherapy, or any investigational agent: ? 21 days (? 42 days if a nitrosourea) prior to screening.
Any cytotoxic chemotherapy, immune checkpoint inhibitor therapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), within 14 days of the first dose of study treatment.
Patients receiving another investigational agent
Subjects who have participated in a clinical trial within 30 days of Screening or are scheduled to receive an investigational product.
Patient has used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment or has plans to use any of these during the course of the study
Administration of any investigational agent within 4 weeks prior to initiating study treatment
Chemotherapy, immunotherapy, targeted therapy, monoclonal antibodies, tumor embolization, or other investigational agent within 28 days prior to the first dose of study drug
Received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Treatment with any investigational agent or on an interventional clinical trial within 30 days prior to treatment on protocol
Previous investigational product (IP) assignment in the present study
Patients who participated in any therapeutic clinical study with an investigational agent within the last 30 days
Participation in another clinical study with an investigational product during the last 4 weeks.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm; NOTE: Bisphosphonates are considered to be supportive care rather than therapy and are allowed while on protocol treatment
Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days
Patient is receiving other investigational drugs
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Administration of another investigational medicinal product within 30 days before the screening period.
Any other on-going chemotherapeutic, biologic, radiopharmaceutical, or investigational agent currently or within 28 days of cycle 1 day 1
Cytotoxic therapy or investigational agent use within 28 days
Participation in another clinical study with an investigational product during the 4 weeks prior to therapy initiation
Have received other investigational drugs within 30 days of enrollment.
Treatment with a non-approved or investigational drug within 30 days prior to day 1 of study treatment
Participation in another clinical study with an investigational product during the last 4 weeks
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
Receiving any investigational agent, that would be considered as a treatment for the primary neoplasm
Received another investigational agent (defined as any agent/device that has not received regulatory approval for any indication) within 14 days of the first dose of study drug for a nonmyelosuppressive agent, or 21 days of the first dose of study drug for a myelosuppressive agent
Currently enrolled in another investigational therapy protocol for AML.
Patients participating in another trial of an investigational agent within 4 weeks of the 1st dose of the study
Anti-cancer therapy, including an investigational agent, less than 14 days prior to the first dose of nivolumab
Participation in another clinical study with an investigational product during the last 6 months
Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to study entry;
Currently receiving chemotherapy, radiation therapy, investigational immunotherapy, or investigational biotherapy for breast cancer
Major surgery (including breast surgery) within < 30 days of starting treatment or received chemotherapy, investigational agents, or other cancer therapy < 14 days prior to the initiation of investigational products (except adjuvant endocrine therapy)
Participation in another clinical study with an investigational product during the last 4 weeks
Patient is currently receiving or has received another investigational agent within 4 weeks prior to day 1 of study
Participated in a previous clinical trial or used any investigational drugs, biologics, or devices within 90 days prior to study treatment or plans to use any of these during the course of the study.
Received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine phosphate [fludarabine])
Treatment with a prior investigational agent within 30 days of first dose of investigational medication
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Participating in any other clinical trials using an investigational product.
Participation in a trial of an investigational agent within the prior 30 days
Received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)
Subject has received an investigational therapeutic agent for prostate cancer within 4 weeks prior to the administration of 131I-MIP-1095
Participation in another clinical study with an investigational product administered during the last 28 days.
Treatment with any small molecule investigational medicinal product (IMP) within 28 days prior to first dose
Any previous treatment with a DDR agent, including any of the investigational agents
Be at least 28 days from last administration of cytotoxic chemotherapy or other investigational agent
Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time.
No investigational agents within 2 weeks prior to first study treatment.
An interval of >= 4 weeks after the last administration of any investigational agent or any other treatment prior to first dose of pembrolizumab
Patients receiving any other investigational agent (s)
Investigational drugs: subjects must not have received an investigational drug within 4 weeks
Current or planned participation in a study of an investigational agent or using an investigational device
investigational product AGS-16C3F and/or,
Receiving any other investigational agent
Patient has received other investigational drugs with 14 days before enrollment
Participation in another clinical study with an investigational product during the last 4 weeks
Use of other investigational drug within 28 days of enrollment.
Receipt of Investigational agents within 28 days prior to first dose of protocol therapy.
Within 28 days before first dose of avelumab: anti-cancer treatment, major surgery requiring general anesthesia, or the use of any investigational agent
Participation in clinical trials with other investigational agents not included in this trial throughout the duration of this trial
Patients who are currently receiving any other investigational agent
Treatment with any investigational agent or on an interventional clinical trial within 30 days prior to registration
Treatment with other investigational agents within 30 days of day 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Administration of any investigational agent within 4 weeks prior to initiating study treatment
Participation in another clinical study with an investigational product during the last 4 weeks (prior use of bevacizumab in the upfront setting is allowed)
Participation in an investigational therapeutic drug trial within 30 days of study entry
Patients who are currently participating in any other clinical trial of an investigational product
Participants who are receiving any other investigational agents or have received investigational therapy or any anti-cancer monoclonal antibody (mAB) within 4 weeks prior to the 1st dose of pembrolizumab
Receiving any other investigational agent, which would be considered as a treatment for the primary neoplasm
Participation in other clinical trials, including those with other investigational agents not included in this trial, =< 30 days prior to registration and throughout the duration of this trial
Patients must not be receiving any other investigational agent
Participation in another clinical study with an investigational product during the last 4 weeks
Exposure to any therapeutic agent (investigational or conventional) within 7 days of date of randomization or to any agent for which 5 half lives have not elapsed
Participation in another clinical study with an investigational product for cancer during the last 12 months
Patients receiving any other investigational agents or whom have received recent treatment for colorectal cancer (radiation within the previous two weeks, chemotherapy or investigational therapy within the previous four weeks)
Any anticancer therapy or investigational agent within prior 3 weeks.
Receiving other investigational agent
At least 21 days have passed since receiving any investigational agent at the time of registration
Receipt of any investigational therapy is not permitted within 28 days prior to the first dose of nivolumab
Currently receiving an investigational agent
Participation in another clinical study with an investigational product during the last 6 months (mo)
Patients who have received any other investigational agent =< 28 days prior to registration are not eligible
Treatment with a non-approved or investigational drug within 28 days of study treatment
Received any investigational drugs within the 14 days prior to the first day of transplant conditioning
Receipt of any investigational agent or study treatment within 30 days prior to C1D1
Patients who have received other investigational drugs within 14 days prior to screening
Current participation in or previous participation in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment
mCRPC EXPANSION COHORT: The patient has received any other type of investigational agent within 28 days before the first dose of study treatment
No treatment with any investigational agent within 30 days prior to being registered for protocol therapy
Other investigational therapy (within 30 days of Study Day 1).
Patients who are currently participating in any other clinical trial of an investigational product
Investigational therapy within 2 weeks of screening
Concurrent treatment with any other investigational agent
Participation in another clinical study with an investigational product during the last 4 weeks
The subject must have no measurable disease at the time of investigational product administration\r\n* The subject must complete all prior surgery requiring general anesthesia at least four (4) weeks before administration of the investigational product; the subject must complete all surgery requiring local/epidural anesthesia at least seventy-two (72) hours prior to administration of the investigational product\r\n* The subject must complete all prior systemic chemotherapy therapy, and all adverse events have either returned to baseline or have stabilized at least four (4) weeks prior to administration of the investigational product\r\n* The subject must complete all prior systemic radiation therapy at least four (4) weeks prior to administration of the investigational product; the subject must complete all prior focal radiation therapy at least two (2) weeks prior to the administration of the investigational agent; the subject must not have received a radiopharmaceutical within eight (8) weeks prior to the administration of the investigational product\r\n* The subject may continue hormonal therapy (i.e. tamoxifen, anastrozole) during the study
Receipt of investigational agents within 5 half-lives of last dose of investigational agent
Receipt of any other investigational agents within 14 days prior to study treatment
Is currently receiving active treatment with anti-cancer systemic chemotherapy, investigational agent, or biological therapy
Treatment with other investigational agent(s) within 30 days of planned lymphodepletion
Use of any investigational agents within 21 days of registration.
Treatment with an investigational product during the last 2 weeks
Receipt of an investigational agent within 28 days (or 60 days for an antibody-based therapy) before the first planned dose of study drugs
Participation in any other investigational study or use of any other investigational agents within 30 days prior to study entry
Recipient must not have received any investigational drug within 30 days of starting conditioning treatment
Treatment with any other investigational agent within 3 weeks prior to the first dose of MEDI4736 and tremelimumab
Concurrent use of investigational therapeutic agent
Any investigational agent within 4 weeks prior to initiating study treatment
Treatment with an investigational therapeutic within 30 days of cycle 1
Participation in another clinical study with an investigational product during the last 3 months
Receipt of a prior investigational study agent within 4 weeks prior to enrollment; *Note- patients who have received anti-CD19 CART cells (e.g. CART19/cytotoxic T lymphocyte [CTL] 019) on an investigational study where cell infusion occurred greater than 4 weeks before the screening visit are NOT excluded
Receiving or less than 21 days since receiving any other concurrent cytotoxic, biologic agent(s) or investigational agent
Subjects must not have received any investigational agents within 30 days of study entry
PHASE I: Patients who are receiving any other investigational agent
Subjects requiring or using other investigational agents while on treatment in this trial.
Administration of an investigational therapeutic within 30 days of cycle 1, day -2
Received investigational treatment in another clinical study within 4 weeks prior to the initiation of investigational treatment;
Use of any investigational agents within 30 days prior to enrollment and for the duration of the study
Treatment with unapproved investigational therapeutic agent within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
Exposure to other investigational drugs within 4 weeks before enrollment
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Investigational agent within 30 days of enrollment without approval from the sponsor- principal investigator (PI)
Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 x half-life for investigational drugs where the half-life is known) preceding informed consent
Patients who are receiving other investigational drugs 14 or fewer days before enrollment
Received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
Participation in another investigational drug study in the prior 4 weeks
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment (the use of Hydrea is allowed)
Any investigational agent within 4 weeks prior to initiating study treatment
Patients receiving an investigational drug within 10 days prior to registration
Have received other investigational drugs within 14 days prior to enrollment
Currently receiving any investigational drug or device in another clinical trial or within 30 days preceding informed consent.
Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment
Receipt of a large molecule anticancer agent (e.g., antibody), including an investigational anticancer antibody, within 28 days of starting study treatment
Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days
Concurrent use of investigational therapeutic agent
Treatment with any investigational compound within 30 days prior to the first dose of study drugs
Use of any investigational product (IP) or investigational medical device within 28 days before day 1 of study drug
Receipt of investigational agents within 5 half-lives of last dose of investigational agent
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Patient has received other investigational drugs with 14 days before enrollment
Any investigational agent within 4 weeks of study treatment initiation
Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days
Treatment with chemotherapy, monoclonal antibodies or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial
Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol; (subject must have recovered from all acute effects of previously administered investigational agents)
Receipt of any other type of investigational agent within 28 days before the first dose of study treatment
Currently receiving any other investigational agents, or received an investigational agent within 3 weeks of the first dose of nintedanib
Use of any investigational drugs within 30 days prior to dosing
Use of any investigational agent within 4 weeks prior to study entry.
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment into the study
Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days
Exposure to any investigational agent within 30 days of date of randomization.
Patient has received other investigational drugs within 14 days before enrollment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
Investigational compound within 4 weeks of enrollment or who are planning to receive other investigational agents while participating in this study
Research participant must be at least 2 weeks out from having received the last dose of investigational agent
Investigational Drugs: Subjects who have received another investigational drug within the last 14 days are excluded from participation.
Use of any investigational agent within 4 weeks prior to the Baseline Visit.
Known or suspected drug sensitivity to cytarabine or the investigational agent ficlatuzumab
Patients should not have received an investigational agent for at least 2 weeks prior to the first study drug dose
Patients who are receiving investigational therapies or who have been treated with investigational therapies or investigational devices within 5 half-lives of the investigational therapy or 4 weeks of first scheduled day of dosing with PFK-158 if the half-live of the investigational agent is not known.
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
The use of any investigational agent in the month before enrollment into the study
Recent Investigational therapy
Participation in an investigational drug or device study or treatment with any antineoplastic agent within 14 days of the first day of dosing on this study
Patients currently receiving high dose systemic steroids for treatment of MM in excess of 320mg total dose of dexamethasone or equivalent, patients who received an investigational agent within 5 half-lives of the agent
Treatment with other investigational drugs within 6 months of study entry
Prior use of radiotherapy or investigational agents for pancreatic cancer
Patient has received other investigational drugs within 4 weeks before enrollment
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
Treatment with a non-approved or investigational drug within 28 days of study treatment
Participation in a clinical study involving receipt of an investigational drug during the last 30 days.
Patients who have received radiotherapy, surgery, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents, immunotherapy, or any other anti-cancer therapy of any kind, or any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of CPI-613 treatment
Received any investigational drugs within the 14 days prior to the first dose of fludarabine
Any other type of investigational agent within 4 weeks before the first dose of study treatment
Investigational agent received within 30 days prior to the first dose of study drug; if received any investigational agent prior to this time point, drug-related toxicities must have recovered to grade 2 or less prior to first dose of study drug
Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
Patients must not have received any investigational agents within 21 days of study entry
Received an investigational agent within 30 days prior to enrollment
Investigational agent within 4 weeks of first dose of study treatment
Enrollment in any other investigational treatment study or use of an investigational agent, or has not yet completed at least 3 half-lives since ending another investigational device or drug trial
Participation in another investigational trial within 90 days
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment
Received an investigational agent within 30 days prior to enrollment
Exposure to other investigational drugs within 2 weeks before enrollment
Any investigational drug within 4 weeks
Patient has received other investigational drugs within 3 weeks before study registration
Patients may not have used any investigational agent within 4 weeks prior to enrollment into the study
While on this study, patients may not be treated with any other investigational agent for any purpose until relapse or progression
Administration of an investigational therapeutic within 30 days prior to cycle 1, day 1
Patients who are receiving any other investigational agent
Patients may not be receiving any other investigational agents and may not have participated in a study of an investigational agent or using an investigational device within five half-lives of the compound or 3 months, whichever is greater
Treated with any investigational therapy within 2 weeks of the first dose of study treatment.
Received any investigational agent for any indication within 30 days prior to first treatment.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
Prior treatment with any investigational drug within the preceding 4 weeks
Known history of hepatitis B or C as these patients may be at risk of disease reactivation when treated with the chemotherapy and/or the investigational agent
Participation in an investigational new drug trial within 28 days prior to initiating treatment on study
Investigational agent: >= 28 days must have elapsed from treatment with a different investigational agent
Administration of any unlicensed or investigational agent within 4 weeks of entry to the study
No prior investigational agent in the 4 weeks prior to initiation of therapy
Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment.
Patients who have received any investigational treatment agent within the last 28 days.
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Currently participating in another clinical trial using an investigational study medication, or recent participation in such a trial
Receiving any other investigational agent which would be considered as a treatment for the lymphoma
Received an investigational drug, was vaccinated with live attenuated vaccines, or used an invasive investigational medical device within 4 weeks before the planned first dose of study drug, or is currently being treated in an investigational study
Treatment with investigational therapy(ies) within 5 half-lives of the investigational therapy prior to the first scheduled day of dosing with VT1021, or 4 weeks if the half-life of the investigational agent is not known.
Received an investigational agent within 30 days prior to enrollment
Participation in another interventional clinical trial or treatment with any investigational drug within 4 weeks prior to study entry.
Prior or current use of any investigational or commercially available anti-HCV agents other than interferon or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration
Treatment with other investigational drugs or anti-cancer therapy within 28 days prior to enrolment.
Participation in another clinical study with an investigational product (IP) during the last 3 weeks before the first day of study treatment
Use of investigational agent within 30 days of signing informed consent
Patients who have received another investigational agent within the previous 3 months
Use of any investigational agent within 30 days of the first radiation dose
Use of investigational agent within last 14 days
Use of any investigational agent within 4 weeks prior to study entry.
Received any investigational agent within the 14 days before the start of ALT-803
Previous treatment with any other investigational agents within 4 weeks prior to MCLA-117 administration;
Use of an investigational treatment (except for ibrutinib) from 30 days prior to the first dose
Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
Use of an investigational treatment (except for ibrutinib) from 30 days prior to the first dose
Use of an investigational agent within 4 weeks of enrollment
Treatment with any other investigational agent within 28 days prior to enrolment.
Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 4 weeks prior to study entry.
Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
4 weeks from any investigational agent
Planned treatment, or treatment with any investigational drug within 4 weeks prior to screening.
Current or recent treatment with any other investigational medicinal product or device
Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration, or plans to start any other investigational product or device study within 30 days after last drug administration.
Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Full recovery (< grade 1) from the toxic effects of any earlier intervention and a minimum of 28 days from the administration of any investigational agent
No treatment with any investigational agent within 30 days prior to registration for protocol therapy
Less than 4 weeks since use of another investigational agent
Participation in an investigational trial within 30 days of study entry
Did not receive any investigational treatment for at least 28 days prior to study entry
Treatment with any investigational agent within 4 weeks prior to baseline
Treatment with any investigational agent within 4 weeks prior baseline
Receipt of any investigational medication within 4 weeks prior to randomization
Patient on other investigational drug
Prior investigational therapy within the past 28 days.
Receiving any other investigational agent
no current or prior use of investigational agents within 4 weeks of study entry.
Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).
201 Treatment within 30 days prior to enrollment with another investigational device or drug (interventional clinical study / studies). Other investigational procedures while participating in this study are excluded (observational studies are permitted).
Patients who have received treatment with any other investigational agent within 4 weeks before initiation of study treatment
Use of any investigational product within 4 weeks prior to randomization
No non-approved investigational agents or procedures ?4 weeks of study entry
Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks prior to first administration of IMP and during study with exceptions
Any other investigational treatments within 4 weeks prior to and during study; includes participation in any medical device or other therapeutic intervention clinical trials
Any other investigational agent or used an investigational device within 21 days prior to day 1 of protocol therapy
Treatment with any other investigational anti-leukemia agent
Participation in another clinical study with an investigational product during the last 3 weeks
Current participation in another clinical study of an investigational agent, vaccine, or device. Concomitant participation in observational studies is acceptable after sponsor approval.
Treatment with an investigational therapeutic drug within 30 days of cycle 1
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
Non-nitrosourea cytotoxic drug or any systemic investigational agent with exception of methotrexate ? 4 weeks
Any investigational agent(s) within 4 weeks prior to entry
Use of other investigational agents within 6 months prior to enrollment
Participation in other investigational studies while enrolled on this trial.
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Systemic anti-cancer therapy or participation in other clinical trials, including those with other investigational agents not included in this trial, ? 28 days of registration and throughout the duration of active treatment in this trial
RENAL COHORT: The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Treatment with any other investigational agent or investigational device within 4 weeks prior to registration (or within five half-lives of the investigational product, whichever is longer); patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre phase I study” where a sub- therapeutic dose of drug is administered) at the coordinating center principal investigator (PI)’s discretion, and should have recovered to eligibility levels from any toxicities
Treatment with other investigational agent within 4 weeks to the first dose of tremelimumab or durvalumab
Investigational therapy within 3 weeks.
Treatment with any investigational drug within 28 days prior to initiating study medications
Patients participating in an investigational new drug protocol within 14 days before enrollment.
Received any investigational drugs within the 14 days before 1st dose of fludarabine
Participation in clinical trials with other investigational agents not included in this trial throughout the duration of this trial
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
Patient who has participated in a prior investigational study within 30 days prior to enrollment
Treatment with other investigational agents within 30 days of day 1
Prior treatment with an investigational agent is allowed but must have been completed >= 28 days prior to randomization with resolution of all treatment-related toxicities to grade =< 1.
No investigational agents within 4 weeks from initiation of study treatment
Use of other investigational drugs
Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or investigational CMV vaccine at any time.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with investigational therapy within 14 days prior to initiation of study drug
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Patients must not receive any other investigational agents while on study or within four weeks prior to randomization
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Any investigational agent within 4 weeks prior to initiating study treatment
Subject has known sensitivity to any of the components of the investigational product AGS67E:
Investigational therapy within 28 days prior to initiation of study treatment
Treatment with any investigational agent within 30 days prior to registration for protocol therapy
Concurrent participation in a clinical trial which involves another investigational agent
Ongoing treatment with any other cancer therapy or investigational agent, with the exception of intrathecal (IT) chemotherapy for leukemia, when indicated
Use of any investigational agent within the last 28 days. For classes of investigational agents that are not known to have prolonged toxicities the wash-out time may be decreased to 14 days after agreement with the Medical Monitor.
TREATMENT: Patients who have had prior treatment with any of the other investigational agents or combinations on this protocol are eligible but will not receive the same investigational agent (everolimus or trametinib) or combination (AZD1775/combination or veliparib/temozolomide); instead, patients will receive an investigational agent or combination prospectively identified to work on a different target in their tumor’s mutation/aberrant pathway
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Concurrent treatment with an investigational agent
Subjects must not have received any investigational agents within 30 days of study entry
Treatment with any investigational drug within 30 days prior to registration.
Participation in another clinical study with an investigational product during the last 4 weeks
Therapy with other investigational agents within 4 weeks of treatment initiation on this trial
Participants who are receiving, or have received, any other investigational drugs or devices within the 2 weeks prior to the first dose of study medications
An interval of >= 4 weeks after the last administration of any investigational agent, bevacizumab, or prior cytotoxic therapy
Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) or receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
Investigational therapy within 4 weeks of Screening.
Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) or receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Patient is receiving any other investigational agent
Subjects having received any other investigational agents within 4 weeks prior to the\n first study drug administration and have not recovered completely (to AEs < Grade 2)\n from the side effects of the earlier investigational agent
Prior investigational immunotherapy
Participation in any other clinical trials with other investigational agents not included in this trial, =< 21 days prior to registration
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Use of an investigational agent within the previous 28 days of study registration
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610
Participation in a prior investigational study within 30 days prior to enrollment
Treatment with any investigational agent within two weeks prior to first dose in this study; hydroxyurea is allowed to control the AML prior to treatment on the study
Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Received investigational drugs within the 14 days of study registration
Use of any investigational product within 30 days prior to randomization
Use of other investigational drugs within 28 days preceding the first dose of trametinib and during the study
Patients with a history of prior therapy with another investigational agent within 4 weeks of the first planned dose of PF-0444913
Patients must not receive any other investigational agents during the period on study or the four weeks prior to entry
Received an investigational agent within 30 days prior to enrollment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment (the use of Hydrea is allowed)
Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
Patients must not be receiving any other investigational agent
Patients may not be receiving any other investigational agents at time of study entry or at any time while on study or be on another investigational agent that can impact on the primary clinical outcome analyses or has known pharmacodynamics or pharmacokinetic effects on AAT
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of IPHC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Receiving any other investigational agent
Concurrent treatment with an investigational agent other than the investigational agent(s) used in this study OR treatment within 4 weeks of study entry with any investigational agent(s) or device(s)
Prior investigational therapy must be completed at least 30 days prior to study entry
Prior chemotherapy (except PLD in Dose Escalation Cohorts only) or any investigational agent within 3 weeks prior to registration
Patients who have received any investigational agent within 30 days prior to day 1
Any investigational drug < 6 weeks prior to the first dose of study drug or not recovered from effects of prior investigational agent
Patients must not be planning to receive any other investigational agents during the course of protocol treatment
Use of any other investigational drug
Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks
Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
Subjects who received any investigational agent ?28 days of study drug initiation.
Subjects who received an investigational agent <14 days prior to their first day of study drug administration.
Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
Patients who received an investigational agent (including AG-120 or AG-221) <14 days prior to their first day of study drug administration. In addition, the first dose of AG-881 should not occur before a period ?5 half-lives of the investigational agent (other than AG-120 or AG-221) has elapsed.
Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening
Any type of anticancer agent (including investigational) within 2 weeks before randomization.
Investigational medicinal product within the last 30 days prior to screening
Investigational medicinal product within the last 30 days prior to screening
Subject is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.
Major surgery within <30 days of starting treatment or received chemotherapy, investigational agents, or other cancer therapy, except hormonal therapy (eg, tamoxifen, aromatase inhibitors), <14 days prior to the initiation of investigational products
A prior line of treatment is considered an induction regimen if it involves an approved or investigational cytotoxic chemotherapy agent, biological agent, and/or hypomethylating agent administered alone or in a combination regimen, with the intent to induce robust cytoreduction (i.e., CR).
A prior line of treatment is considered an induction regimen if it involves an approved or investigational cytotoxic chemotherapy agent, biological agent, and/or hypomethylating agent administered alone or in a combination regimen, with the intent to induce robust cytoreduction (i.e., CR).
The patient has received treatment with another investigational agent within 14 days of study entry.
Any other type of investigational agent within 28 days before the first dose of study treatment
Participation in a clinical trial with an investigational therapy within 30 days prior to randomization
Concomitant use of any other investigational drugs
Patients who were currently receiving any other investigational agent.
Any investigational agents from a previous clinical study within 4 half-lives of said prior investigational agent(s) with regard to the first dose of study treatment on this protocol.
Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
Concomitant use of any other investigational or anticancer agent(s).
Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment
Receipt of systemic anticancer therapy, including investigational agents, within 28 days of starting study treatment. If anticancer therapy was given within 28 days of starting study treatment, patients may be included if 5 times the elimination half-life of the drug has passed. a biologic anticancer agent (e.g., antibody), including an investigational anticancer antibody, within 28 days of starting study treatment
Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to randomization.
? 28 days elapsed from the administration of any investigational agent
Any anti-cancer treatment within 14 days or any investigational agent within 30 days before the first dose of study drug.
Treatment with any investigational product within < 4 half-lives for each individual investigational product OR 28 days prior to randomization
Patient has an investigational medicinal product within the last 30 days prior to screening.
Use of any investigational agent within the 4 weeks preceding enrollment
Any investigational agent within 3 weeks of Day 1 of trial drug treatment
Known sensitivity to any of the ingredients of the investigational product AGS15E
Any investigational therapy within 28 days prior to the first dose of IP.
Any investigational therapy within 28 days prior to the first dose of IP.
First day of dosing with tesevatinib is less than 2 weeks from treatment with another investigational agent
Received an investigational agent within 4 weeks prior to enrollment
Treatment with any investigational drug within 28 days before randomisation.
Prior treatments usage as defined: A) Use of an investigational anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of the investigational products:; B) A minimum of 14 days between termination of the investigational drug and administration of GSK525762; C) Any therapy related toxicities must also have resolved to Grade 1 or less. Note that an investigational drug is defined as a drug without an approved oncologic indication; D) Chemotherapy, radiotherapy, anti-neoplastic antibody or targeted therapy or immunotherapy within 14 days, major surgery within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of the investigational product. Anti-androgen (e.g., bicalutamide) therapies for prostate cancer must be stopped 4 weeks prior to enrollment. Second line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped 2 weeks prior to enrollment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to 10 mg/day) and still be eligible for this study.
Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
Previously received an investigational antineoplastic agent for NSCLC.
Use of any investigational agent within 28 days of randomization.
Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.
Receipt of any investigational medication within 4 weeks prior to enrollment
No investigational agent within 4 weeks prior to first dose of study drug.
Enrollment on any additional investigational agent study. Enrollment on concurrent observational study is allowed following consultation with the Sponsor.
Have been treated with an investigational agent within 4 weeks prior to the first day of IP administration.
Subject who is receiving or has received any other investigational agents within 28 days prior to day 1 of treatment in this study; in addition, day 1 of the study treatment should be at least 14 days after prior chemotherapy
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed.
Investigational therapy within 4 weeks of Screening.
Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment or receipt of a biologic anticancer agent (e.g., antibody) within 28 days of starting study treatment.
Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Administration of any investigational agent within 28 days of first dose of study drug
Prior treatment in any other clinical trial involving another investigational agent within 4 weeks prior to Day -31 of the study; resolution of respective adverse event to Grade 1 or lower should have occurred
Participants who have received any anticancer treatment within 3 weeks or any investigational agent within 30 days before the first dose of study drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.
Currently enrolled in another clinical trial (exclude non-cancer treatment trial) or received an investigational agent within 4 weeks of study initiation
Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
Any investigational agent within the previous 30 days.
Treatment with any other investigational agent within 28 days prior to registration. Subjects must not be treated with any other investigational agent while on protocol specified therapy.
Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study
Treatment with radiotherapy, any chemotherapeutic agent, systemic steroids used as an anti-neoplastic agent, or any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
Have discontinued investigational product or non approved use of a drug or device from a clinical trial within 30 days before the first day of study treatment.
Systemic treatment on any investigational clinical trial within 28 days prior to registration.
Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
An interval of >= 4 weeks after the last administration of any investigational agent or prior cytotoxic therapy (except bevacizumab); there should be 14 days interval between the last dose of bevacizumab and first day of treatment on study
Patient has received other investigational drugs with 14 days before enrollment
Participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing.
Participation in a therapeutic investigational study within 4 weeks prior to enrollment, or anticipated treatment with another investigational product while on study; this refers to non-commercially approved investigational drugs different than those used in this protocol
Treatment with any investigational drug within 28 days prior to randomization
Participation in the active phase of other clinical trials of investigational agents in which last study treatment was administered within 2 weeks prior to randomization
Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (day -7)
Treatment with any other investigational agent
Investigational agent received within 30 days prior to the first dose of study drug
Patients who have received any investigational agent, chemotherapy, interferon-alfa, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to day 1
Current or past use of investigational agents within 4 weeks of study enrollment
Other investigational agents within 21 days prior to study treatment.
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Participation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization.
Another investigational drug
Subjects who have received investigational drugs =< 4 weeks prior to registration
Patients participating in an investigational new drug protocol within 14 days before enrollment
No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
Exposure to any investigational agent, systemic chemotherapy, or therapeutic radiation within 21 days of enrollment (Part 1) or randomization (Part 2).
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Investigational agent within 21 days prior to day 1 of protocol therapy
The patient has received treatment with an investigational systemic anticancer agent within 14 days prior to study therapy administration.
Previously received treatment with RGX-104 or another investigational agent that is a known LXR agonist.
Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment.
Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study
Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
Patients on other investigational drugs while on study will be excluded
Receipt of any investigational medication within 4 weeks prior to enrollment
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Received no other investigational therapy within the past 14 days
Treatment with an investigational agent within 4 weeks of starting treatment.
Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR-214.
Participation in another clinical study with an investigational product during the last 21 days
Participation in another clinical study with receipt of an investigational product during the last 4 weeks
Treatment with any systemic anticancer treatment or an investigational agent within 4 weeks and any radiation within 2 weeks of registration
Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Concurrent enrollment in another therapeutic clinical study or receipt of an investigational product within the last 4 weeks (participation in the survival follow-up period of a study is not an exclusion criterion)
Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent such as a monoclonal antibody).
Administration of any investigational agent within 28 days of first dose of study drug
Receipt of any investigational medication within 2 weeks prior to enrollment
Treatment with any investigational agent within three weeks prior to first dose in this study
Concurrent use of investigational therapeutic agent
Received an investigational agent within 30 days prior to registration
Investigational compound within 4 weeks of enrollment
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Treatment with any investigational agent within 28 days of first administration of study treatment
Treatment with any investigational agent within three weeks prior to first dose in this study
Patients must have received their last dose of any other investigational agent greater than 28 days prior to enrollment (with exception of fluorothymidine F-18 [FLT])\r\n* Patients must have received their last dose of any other biologic agent greater than 7 days prior to enrollment
Currently receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Use of an investigational agent within 4 weeks before the screening visit;
Investigational drug use within 28 days of randomization.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Taking an investigational agent within 4 weeks of initiation of everolimus
Received other cancer treatment or investigational drug within 4 weeks prior to screening
Participants should not have received any other investigational agents nor have participated in an investigational trial within the past 4 weeks
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
Received any chemotherapeutic or targeted agent (approved or investigational) for NSCLC within 2 weeks of initiation of pacritinib (with the exception of erlotinib)
Other investigational drugs within 4 weeks prior to enrollment, unless cleared by the Principal Investigator
Prior investigational agents =< 4 weeks prior to registration
Current or planned participation in a study of an investigational agent or using an investigational device
Subjects who have received investigational agents within 28 days of the first day of study drug.
Use of investigational agents of any kind within 30 days before study treatment
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Receiving any other investigational agent =< 4 weeks prior to registration which would be considered as treatment for the primary neoplasm
Patient who has participated in a prior therapeutic investigational drug study within 30 days prior to enrollment
Participation in another investigational drug study in the prior 8 weeks
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Patient has received an investigational agent or used an investigational device within 28 days of the first dose of study drug
Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study
Treatment with chemotherapy, monoclonal antibodies, biological agents (e.g. Ibrutinib) or other than the investigational agents during the time of participation in this trial
Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol; (subject must have recovered from all acute effects of previously administered investigational agents)
Receipt of anticancer therapy within 28 days prior to the first dose of Investigational Product
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Participation in any other research protocol involving administration of an investigational agent within 6 weeks prior to study entry
Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Known sensitivity to any of the components of the investigational product AGS67E:
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Other investigational agents =< 4 weeks prior to registration/ randomization
Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
Use of other investigational drugs within 28 days preceding the first dose of vemurafenib during this study
Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.
Administration of an investigational agent within 4 weeks of Treatment Cycle 1, Day 1
Participation in an investigational anti-cancer study within 3 weeks prior to initiation of therapy
Other investigational treatment during or within 21 days before starting study treatment
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
At least 4 weeks must have elapsed from the use of any other investigational agent prior to starting study drug
Treatment with investigational therapy within 2 weeks of study treatment
Use of investigational agent within 28 days prior to Randomization
Patients receiving other investigational agent
Investigational drugs: subjects must not have received an investigational drug within 4 weeks
Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment
Subjects who received an investigational agent <14 days prior to their first day of study drug administration. In addition, the first dose of AG-120 should not occur before a period ?5 half-lives of the investigational agent has elapsed.
Use of an investigational treatment from 30 days prior to the first dose of SNX-5422 and during the study.
Use of an investigational agent within 2 weeks of enrollment (day 1 visit)
Currently receiving another investigational agent
Use of any investigational product or investigational medical device within 28 days prior to enrollment
Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.
Patient who will be receiving another investigational product during the study
At least 3 weeks since prior biologics or investigational agents
Received an investigational agent within 4 weeks prior to enrollment
No treatment with an investigational product or device within 21 days of cycle 1 day 1
Subjects who are receiving any other investigational agents or who have received an investigational agent within 28 days prior to enrollment (does not apply to participation in survival follow up), or who have previous exposure to vandetanib
Receiving any other concurrent cytotoxic, biologic agent(s) or investigational agent
Receiving another investigational agent (30 day wash-out required prior to first dose)
Other investigational therapy (not included above) within 3 weeks of randomization
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
History of receiving any investigational treatment within 21 days prior to enrollment into the study
Radiotherapy or systemic therapy (standard or an investigational or biologic anticancer agent) within 14 days of initiation of study drug treatment
Current enrollment in another clinical trial involving treatment and/or is receiving an investigational agent for any reason
Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
If a subject previously received investigational treatment, the last dose of investigational treatment was administered within 4 weeks of Day 1 of the study or adverse event(s) attributable to investigational treatment have not resolved to Grade 1 or better.
Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment;
Subjects must have received their last dose of investigational or biologic agent >= 7 days prior to study registration\r\n* In the event that a subject has received an investigational or biologic agent and has experienced >= grade 2 myelosuppression, then at least three (3) weeks must have elapsed prior to registration\r\n* If the investigational or biologic agent has a prolonged half-life (>= 7 days) then at least three (3) weeks must have elapsed prior to registration
The patient has received any investigational therapy ? 28 days prior to start of Investigational Product. Investigational therapy is defined as any medicinal product that is not approved in the country of treatment for any indication, adult or pediatric.
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Use of any investigational agent within 4 weeks prior to study entry.
Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
Receipt of treatment with another investigational device or drug
No treatment with any investigational agent within 30 days prior to study registration.
Current or anticipated use of other investigational agents while participating in this study
Received ibrutinib or following therapies considered investigational for treatment of cGVHD including imatinib, bortezomib, ruxolitnib, or entospletinib, within 4 wks prior to starting AMG 592 or is currently receiving treatment in another investigational drug or device study.
Prior use of investigational drugs =< 14 days prior to registration
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Patients receiving any other standard or investigational treatment for their cancer, or any investigational agent for any non-cancer indication within the past 2 weeks prior to initiation of CPI-613 treatment
Patient has received other investigational drugs with 14 days before enrollment
Patient has received other investigational drugs with 14 days before enrollment
Subjects who received a small molecule investigational agent <14 days prior to their first day of study drug administration. In addition, the first dose of AG-221 should not occur before a period ?5 half-lives of the investigational agent has elapsed.
Receipt of any other investigational agents within 14 days prior to study enrollment
Concomitant use of any other investigational drugs
Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) before the first planned dose of study drugs
Patients who have participated in a window study (treatment with an investigational agent prior to surgery for =< 2 weeks) are eligible; patients must have discontinued the investigational agent at least 14 days before participation
Patients who have received any investigational agent within 4 weeks of enrollment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 (6,8-bis[benzylthio]octanoic acid) treatment
Receipt of any other investigational agent within the 28 days prior to Day 1.
Treatment with an investigational agent ? 30 days prior to randomization
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment
Participation in an investigational therapeutic study within 3 weeks prior to first dose
Having received an investigational agent within 30 days prior to the first dose of study treatment
Prior sipuleucel-T treatment or investigational immunotherapy.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Treatment with other investigational agents =< 14 days of registration
Prior treatment with any investigational drug within the preceding 4 weeks
The patient has received any investigational agents within 4 weeks prior to their first dose of sorafenib
Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Receiving any other investigational agent that would be considered a treatment for the primary neoplasm
Patients that are receiving any other investigational agent
No patients receiving other investigational therapy for the past 30 days before dosing.
Participation in an investigational therapeutic drug trial within 30 days of study entry
Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1
Treatment with a non-approved or investigational drug within 30 days before visit 1
Taking other investigational drugs
Treatment with a systemic investigational agent within 28 days before the screening visit.
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Patient has received an investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within 2 weeks of study
Patient must not have received any other investigational agents within 14 days prior to study enrollment
Treatment with an investigational agent within 4 weeks before dosing
Treatment with any investigational agent within 14 days of first administration of study treatment
Patients who have not yet completed at least 21 days (30 days for prior monoclonal antibody therapy) since ending other investigational device or drug trials, or who are currently receiving other investigational treatments
Patients who have received any other investigational agent in a 28-day period prior to enrollment in this study
Subjects receiving other investigational agents thirty days prior to study treatment or during treatment
Receiving any investigational agent currently, or within 2 weeks of day 1 of treatment on this study
Ongoing treatment with any other investigational therapy
Participation in another investigational drug clinical trial
Receipt of another investigational drug within 14 days of enrollment.
Concomitant use of any other investigational drugs
The participant has received any other type of investigational agent within 28 days before the first dose of study treatment
Current enrollment in another clinical trial involving treatment and/or is receiving an investigational agent for any reason
Patients who have participated in any therapeutic clinical study/received any investigational agent within the last 30 days are excluded from participation in this trial.
Prior treatment with any investigational drug within the preceding 4 weeks
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Received an investigational agent within 30 days prior to enrollment
Concurrent use of other investigational agents and patients who have received investigational drugs =< 4 weeks prior to enrollment
Individuals who have received any investigational drug within 4 weeks
Participation in another investigational drug clinical trial.
Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1
Patient has received other investigational drugs within 3 weeks before study registration
Treatment with other investigational agents in the prior 4 weeks.
Use of an investigational agent, including an investigational anti-cancer agent, within 14 days prior to the first dose of study drug
Treatment with investigational agent within 30 days prior to enrollment
Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol
Use of investigational agents within 4 weeks prior to enrollment
Current enrollment in any other investigational treatment study
Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
Treatment with other investigational agents within 30 days of day 1
Patients who are using other investigational agents or who had received investigational drugs =< 4 weeks prior to study treatment start
Participants may not be receiving any other study agent
Received investigational drugs within the 14 days before enrollment
Treatment with an investigational product or device within 21 days of cycle 1 day 1
Received any investigational drugs within the 14 days before 1st dose of fludarabine
No use of an investigational agent within 2 weeks of starting ECP
E 09. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
Patients receiving an investigational agent within 30 days before enrollment
Patient has received other investigational drugs within 14 days prior to enrollment
Patient has received other investigational drugs with 14 days before enrollment
Patient has received other investigational drugs with 14 days before enrollment
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Participation in another clinical study with an investigational product during the last 14 days
Currently receiving a study therapy or if they had an investigational agent within 4 weeks at the time of enrollment.
Current active treatment with an investigational agent
Participation in another clinical study with receipt of an investigational product during the last 4 weeks
Participation in another clinical study with an investigational product during the previous 4 weeks
Any investigational agent within 4 weeks of first dose of study treatment
Patients must not have received any other investigational agents within 30 days prior to vaccination.
Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start
Patient participating in another clinical trial or receiving an investigational drug
Participation in any clinical study or having taken any investigational therapy within 28 days.
Treatment with a an investigational agent within 30 days prior to the first dose of dasatinib/ATRA or planning to receive an investigational agent during the study
Patients who have received any investigational agent, chemotherapy, interferon-?, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to first dose
Patient has received other investigational drugs with 14 days before enrollment.
An investigational agent within the past 30 days
Treatment with hydroxyurea, busulfan, cytoreductive agents other than frontline TKI, or an investigational agent within 28 days of registration; patients who are on alpha-interferon as primary therapy are not eligible
Patient has not received other investigational drugs with 14 days before enrollment
Current use of an investigational agent
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
Any investigational agent, other than NEOD001, within 4 weeks
Treatment with any investigational agent within 28 days before the first dose of study treatment
Subjects who participated in any other investigational drug trial or had exposure to any other investigational agent, device or procedure <4 weeks prior to Screening and throughout the entire trial, with the exception of investigational drugs administered prophylactically for CMV post allogeneic HCT.
Treatment with any investigational agent within 28 days prior to registration.
Patients must not be receiving any other investigational agent
Participation in an investigational research study using an investigational agent within 30 days of screening
Participation in a clinical trial of an investigational device or drug within 4 weeks of study entry.
Concurrent participation or participation within the last 30 days prior to enrollment in any clinical trial with an investigational medicinal drug/chemotherapeutic or biologic or medical product.
Be currently enrolled in another investigational treatment protocol
Participation in clinical trials with other investigational agents not included in this trial throughout the duration of this trial
Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or investigational drug study(s), or subject is receiving other investigational agent(s)
Patients may not be receiving any other investigational agent with therapeutic anticancer intent
Participation in another clinical study with an investigational product during the last 4 weeks
Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Receipt of investigational drugs within 14 days before D1 of alisertib
Ongoing investigational treatment
Use of an investigational therapeutic agent with 4 weeks of enrollment
Investigational drug other than NEOD001 within 4 weeks
Treatment with an investigational agent within 30 days prior to the first dose of SNX?5422 or planning to receive an investigational agent during the study.
Exposure to an investigational product or investigational device in another clinical study within 4 weeks prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
Having received an investigational agent with 21 days of receiving the first dose of study drug on this trial
Use of an investigational agent within 4 weeks of Day 1 visit.
Treatment with other investigational agents within the prior 7 days prior to the 1st dose of AbGn-168H (neihulizumab)
Other investigational agent within 3 weeks prior to initiation of study therapy
Use of an investigational drug within 30 days prior to screening.
Other investigational agents currently or within 30 days prior to study enrollment
Use of any investigational drugs, biologics, or devices within 28 days prior to study enrollment
Use of any investigational drug within 4 weeks
Subject is enrolled in any other clinical protocol or investigational trial with an interventional agent or assessments that may interfere with study procedures.
No investigational drug within 4 weeks of starting study treatment.
Investigational agent received within 30 days prior to the first dose of study drug; if received any investigational agent prior to this time point, drug-related toxicities must have recovered to grade 2 or less prior to first dose of study drug
Use of any investigational agent within 28 days prior to Baseline.
Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy.
Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy.
Received an investigational agent within 30 days prior to enrollment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
Use of any investigational drug or treatment within 4 weeks prior to enrollment
Receiving any other investigational agents or receipt of another investigational agent within 4 weeks of study entry
Patients may not be receiving nor have received any other investigational agent =< 4 weeks prior to study registration
Receipt of any investigational agents within 14 days before the first dose of ibrutinib
History of receiving any investigational treatment within 28 days of study medication initiation
Subjects receiving concomitant treatment with radiotherapy or other investigational drugs
Receipt of any investigational agent within 4 weeks prior to 1st dose
Prior to study treatment administration, at least 21 days must have elapsed since the subject's prior investigational or non-investigational systemic therapy, or any major surgery, and at least 21 days since prior radiotherapy.
Received an investigational agent for another disease within 30 days prior to enrollment
Patient should not be part of another trial testing other investigational agents or devices
Patients should not participate in any other therapeutic investigational study while taking part in this study
Concomitant use of any other investigational drugs
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Subjects who have received any other investigational drug or agent within 28 days of first dose of TH-302
Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study
Patients who are receiving any other investigational agent
A minimum of 4 weeks must have elapsed since the administration of all other investigational agents
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to day 1 of the study.
Patient is enrolled in any other therapeutic clinical protocol or investigational trial
Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
Subjects previously treated on another investigational agent must have a 2-week or more washout before starting cabozantinib, depending on the agent, toxicity profile, and half-life; however, such patients may begin tetracycline dosing after consent is signed
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Patient is enrolled in any other therapeutic clinical protocol or investigational trial
Patient must not have received treatment with other investigational agents within the last 4 weeks
Be currently enrolled in another investigational protocol
Patient has received other investigational drugs with 14 days before enrollment
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Receiving any other investigational agent considered as a treatment for the primary neoplasm
Any investigational therapy in the past 30 days
Subjects who have received investigational agents must wait at least 4 weeks
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to the first dose of study treatment
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Biologic or investigational agent (anti-neoplastic): patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent >= 7 days prior to study enrollment \r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur, and discussed with the principal investigator
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Known or suspected allergy to the investigational agent or any agent given in association with this trial.
Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 2 weeks prior to treatment in this study
Administration of any investigational agents within 30 days before study entry
Participation in any investigational drug study within 28 days prior to ISF35 administration; (subject must have recovered from all acute effects of previously administered investigational agents)
Treatment with a non-approved or investigational drug or agent within 30 days before day 1 of trial treatment
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed
Treatment with any investigational agent within 3 weeks prior to first dose in this study.
The subject has received any investigational agent within 28 days before the first dose of study treatment
Treatment with another investigational agent under the following conditions:
Concomitant treatment with another investigational agent while participating in this trial.
Patient has received other investigational drugs within 1 week before enrollment.
Current treatment with another investigational agent.
Use of any other investigational agent within 21 days before day 1.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Received any other investigational therapy within 28 days of Day 1; or
More than 4 weeks from any investigational agent.
Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
Patients who are receiving any other investigational agents; if the patient received a previous investigational or other agent or treatment, a washout period of 4 weeks is required
Receipt of any investigational treatment within 4 weeks of scheduled dosing day 1.
Use of any investigational agent within the last 28 days
Prior treatment with any investigational product within the past 4 weeks
Subjects who have participated in another investigational study within 30 days prior to surgery.
Subjects who have received any other investigational agents within 30 days of first lithium dose
Treatment with an unapproved, investigational agent within 21 days of the first dose of study drug
Prior participation in an investigational study (procedure or device) within 21 days of study day 1
investigational drug within 28 days
Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
Ongoing treatment with any other investigational therapy
Concurrent treatment with an investigational agent
Treatment with any investigational agent <=3 weeks prior to first dose of study treatment
Receiving other investigational agent
Participation in a trial of an investigational agent within the prior 30 days
Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276.
Receipt of investigational therapy in a clinical trial setting within 30 days of enrollment;
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment; the following exceptions are allowed:\r\n* Unapproved/ experimental TKIs discontinued 14 days prior to cycle 1, day 1
Use of other investigational drugs within 28 days preceding the first dose of vemurafenib on this study.
Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
Patients who have received any investigational drug within 28 days prior to Day 1 of study entry (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy
Treatment with any investigational product within 28 days prior to signing the ICF.
Received an investigational agent <14 days prior to their first day of study drug administration. In addition, the first dose of AG-221 should not occur before a period ?5 half-lives of the investigational agent has elapsed
Patients receiving other investigational agent
An investigational therapy.
Patients receiving any other current investigational therapeutic agent.
Prior exposure to an investigational agent or device within 30 days of signing the ICF. Of note, the subject may participate in observational studies;
Any other investigational drug/medical device within 3 weeks prior to the first dose
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to Day 1 of Cycle
Treatment with a non-approved or investigational drug within 30 days prior to day 1 of study treatment
Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to study entry
Treatment with an unapproved, investigational therapeutic agent, immunotherapy or biological therapy within 21 days prior to the first dose of study drug
Exposure to any investigational agent within 30 days of date of randomization.
Use of other investigational drugs
Exposure to any investigational agent within 30 days of Randomization.
Patients who have been treated with an investigational agent <21 days prior to day 1 of cycle 1
Has the subject received any investigational treatment within the past 30 days?
Recently received an investigational agent or device
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Participation in concurrent study of an investigational agent or device.
Received an investigational agent within 30 days prior to enrollment
Receipt of an investigational drug within 28 days prior to initiation of study treatment
Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
Use of an investigational therapeutic agent within 30 days
Use of investigational device or agents within 2 weeks of enrollment date.
Concurrent use of other investigational agent
Investigational therapy or any other therapy =< 28 days before first study treatment
Patient has received other investigational drugs with 14 days before enrollment
Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
Patient has received other investigational drugs with 14 days before enrollment
Use of other investigational agents within 6 weeks of day 1 of protocol therapy
Participant has been exposed to an investigational product (IP) or investigational device in another clinical study within 4 weeks prior to IP administration, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Subject may not receive another investigational agent.
Participation in another clinical study with an investigational drug within 30 days of Screening.
Treatment with another investigational drug or device within 28 days prior to Day 1
Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm
Investigational agents within 4 weeks of initial study treatment.
The patient received treatment with another investigational agent within 14 days of screening.
Must be 28 days from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
Use of an investigational agent within the past 30 days
Any investigational agent is acceptable if administered >= 30 days before registration
Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation
Use of any investigational agent within 28 days prior to start of CA-4948
Current participation in a treatment study or past participation in a study of an investigational agent within 4 weeks before the first dose of study treatment
Current participation in a treatment study or past participation in a study of an investigational agent within 4 weeks before the first dose of study treatment
Prior treatment with any investigational drug within the preceding 2 weeks
Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
Administration of an investigational therapeutic within 30 days of screening
Receiving any other investigational agent
Patients may not have received an investigational agent within 4 weeks of starting this trial
Use of anti-cancer treatment (including investigational drugs) within 28 days
Patient has received other investigational drugs within 14 days of treatment initiation
Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration
Donor must not be currently enrolled on another investigational agent study.
Use of investigational drug within 4 weeks of Day 1 Week 1 or current enrollment in an investigational drug or device study
Patient has received other investigational drugs within 14 days before treatment of treatment with brentuximab vedotin
Treatment with any other investigational agent within 28 days prior to randomization
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Patients may not use any of the following therapies during the study:\r\n* Any non-study anti-cancer agent (investigational or non-investigational)\r\n* Any other investigational agents\r\n* Any other (non-CA184024 related) CTLA-4 inhibitors or agonists\r\n* CD137 agonists\r\n* Immunosuppressive agents\r\n* Chronic systemic corticosteroids\r\n* Any non-oncology vaccine therapies used for the prevention of infectious diseases (for up to 30 days prior to or after any dose of study drug)
Received treatment with an investigational agent within 4 weeks of study entry, or is actively participating in another interventional clinical study.
Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s) or subject is receiving other investigational agents.
Has received investigational therapy within 2 weeks prior to randomization
Participation in another clinical trial or use of any investigational drug within 30 days prior to study entry
any investigational treatment within the past 30 days
No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
Patients may not be receiving any other investigational agent with therapeutic anticancer intent
Prior treatment with any investigational drug within the preceding 4 weeks
Any other investigational agent within 28 days of study entry
Concurrent treatment with an investigational agent or participation in another treatment clinical trial;
The participant is receiving any other investigational agent(s)
Patient received chemotherapy, biological or investigational agent ? 28 days prior to enrollment.
Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
Received investigational therapy or procedure ? 30 days prior to enrollment.
Treatment with a investigational drug within 28 days before Day 1 of trial treatment.
Planned administration of alemtuzumab (Campath-1H) or other investigational agents as alternative agent for GVHD prophylaxis
Received an investigational agent for any indication within 30 days prior to first treatment
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
Receiving any other investigational agent which would be considered as a treatment for AL amyloidosis
Patients receiving any other investigational agent(s)
Participation in another clinical study with an investigational product during the last 14 days
Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study drug
Patients who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half -lives before registration or is currently enrolled in the treatment stage of an investigational study are not eligible; please contact PI for further details on wash-out period and eligibility of such patients
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Received an investigational agent within 30 days prior to enrollment
Participation in an investigational anti-cancer study =< 3 weeks prior to cycle day 1
Concurrent use of investigational therapeutic agent
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Concurrent use of investigational therapeutic agent
Received an investigational agent within 30 days prior to enrollment
Currently receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Patients may not be receiving any other investigational agent
Treatment within the last 30 days with any investigational drug
Patients who have received previous cytotoxic chemotherapy including an AC-T regimen or previous therapeutic radiation therapy for any reason in the last 5 years; because of possible limitations in bone marrow reserve, patients with such prior treatments are not appropriate candidates for this trial; patients who have had prior hormonal therapy (for instance, tamoxifen for prevention of breast cancer) are eligible; patients who have participated in a window study (treatment with an investigational agent prior to surgery for =< 2 weeks) are eligible but must have discontinued the investigational agent at least 14 days before enrollment
Use of an investigational therapeutic within 30 days
Patient has received an investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within 7 days of study entry
Use of investigational agents, with the exception of gemtuzumab ozogamicin, within 30 days
Investigational treatment or clinical trial within 4 weeks.
Investigational therapy other than enzalutamide.
Received an antineoplastic therapy or investigational agent after treatment with talazoparib in the originating protocol.
28 days from the administration of any investigational agent
Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
Patient is currently receiving or has received another investigational agent within 30 days or monoamine oxidase inhibitor within 14 days prior to Lazanda administration
Patient who is participating in any investigational agent that is not Food and Drug Administration (FDA)-approved
Systemic therapy or investigational agent administered < 28 days prior to treatment with nintedanib
Current participation in a trial with another investigational agent, unless co-enrollment is approved by the principal investigators (PIs) of both studies
Any prior investigational CMV vaccine
Other investigational product-concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Any prior investigational CMV vaccine
Received an investigational agent within 30 days prior to enrollment
Any prior investigational CMV vaccine
Other investigational product — concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Receiving any other investigational agent
Receiving any approved or investigational anti-cancer agent other than those provided for in this study
Participation in another clinical trial or use of another investigational agent within 30 days of study entry
Enrollment in another investigational drug trial
Received any investigational agent =< 28 days before Treg infusions
Prior treatment with any investigational drug or device within 30 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational procedures;
Participation in an interventional, investigational non-immunotherapy study within 2 weeks of the first dose of study treatment.
Have received other investigational drugs within 28 days prior to enrollment
Participation in any other investigational treatment within the 6 weeks prior to enrollment or concurrent with this study.
Initiation of investigational agent =< 3 days after initiation of radiotherapy
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other investigational drugs within 4 weeks prior to enrollment, unless cleared by the principal investigator
Subjects who have received treatment with an investigational agent within 30 days of the projected first administration of Investigational Product (Day 0)
Subjects with a known sensitivity to any of the Investigational Product components
Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
Patients must not have received any investigational agents within 30 days prior to commencing study treatment
Use of any investigational agent within 30 days of randomization
Subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
Treatment with any investigational agent within 30 days prior to registration for protocol therapy
Concurrent participation in a clinical trial which involves another investigational agent
Concurrent participation in another study involving investigational drugs or investigational medical devices
Use of investigational agent within 30 days of study entry
Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
Participation in an investigational study that has acute GVHD as the primary endpoint
Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
Administration of any investigational agent =< 30 days prior to pre-registration
Patient is using or plans to use an investigational agent for the prevention or treatment of VOD.
Patient is receiving or plans to receive other investigational therapy during study.
Participation in another clinical trial involving an investigational product within 30 days prior to screening; or
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Use of any other investigational agents =< 12 weeks prior to pre-registration
Treatment with any investigational drug or investigational biologic within 30 days of initiating study treatment or during the study
Concurrent treatment with other investigational agent
Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
RECIPIENT: Any prior investigational CMV vaccine
RECIPIENT: Other investigational product – concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Treatment with any investigational drug or investigational biologic within 30 days of initiating study treatment or during the study
Patient aged < 6 years who received any investigational drug (defined as a medication with no marketing authorization granted for any age class and any indication) within 90 days prior to Day 1, or patient aged 6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
Patient who is receiving investigational agent(s) as part of another clinical study at the time of screening or who anticipates receiving investigational agent(s) during their scheduled radiotherapy and concomitant daily temozolomide therapy (e.g. through the BMX001, MRZ 112, and BMX 209-548 studies)
Received any investigational agent within the 14 days before the start of study treatment (1st dose of ALT-803)
Patients who have received an investigational drug within 30 days of enrollment in study
Enrollment on an interventional investigational study
Patient has used any investigational drugs, biologics, or devices within 14 days prior to study treatment or plans to use any of these during the course of the study
Participation in an investigational study that has acute GVHD as the primary endpoint
Has received an investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical study with an investigational agent during the 12-week study period
Exposure to any investigational agent (defined as any agent not approved by the Food and Drug Administration [FDA]) within 30 days prior to the Screening Visit
Currently enrolled on an interventional investigational study
Patients who have participated in a clinical trial of an investigational drug within 12 months prior to enrollment
Use of non-study investigational agent(s) =< 3 months prior to randomization
Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Participation in a trial of an investigational medicinal product within the previous 28 days
Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of the conditioning regimen
The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Receiving any other investigational agent =< 3 months prior to registration/randomization, except innocuous agents with no known interaction with the study agent (e.g., standard dose multivitamins or topical agents for limited skin conditions)
Known clinically-significant doubling in marrow or perIP (INVESTIGATIONAL PRODUCT) heral blood blast percentage (to ? 20%) in the 8-week period leading to the first dose of IP (INVESTIGATIONAL PRODUCT) (Cycle 1, Day 1)
Use of any of the following within 28 days prior to the first dose of IP (INVESTIGATIONAL PRODUCT):
Treatment with any local or systemic anti-neoplastic therapy or any other investigational agent in the 4 weeks prior to study drug administration
Patients may not be receiving any other investigational agents; any prior investigational therapeutic products must be stopped at least 28 days (4 week washout) prior to treatment start
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed
Investigational Drugs: Patients who are currently receiving another investigational drug are excluded from participation.
Participation in another clinical study with an investigational product during the last 14 days
Receipt of any investigational agents within 30 days prior to commencing study treatment
Has, is, or is planning (during the study) to participate in any study involving administration of a CMV vaccine or another CMV investigational agent
Participants may not receive any other investigational agents within 30 days of enrollment nor during study participation
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:
Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents
Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]
Participants who are already enrolled in a conflicting investigational trial
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an investigational new drug [IND] for initial efficacy investigations)
Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an investigational new drug (IND) for initial efficacy investigations
Concomitant investigational therapy
Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment
Treatment with another investigational drug or other intervention with 24 hours of injection
Concomitant investigational therapy
Planned treatment with agent targeting PI3K/mTOR pathway (either standard of care or investigational agent)
Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of [18F]-ML-10.
Current enrollment in an investigational drug or device study, or participation in such a study within 30 days of first administration of the hormonal agent
Patient is participating in a clinical trial of another investigational drug or device
Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments
Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), within 14 days of the first dose of study treatment
Agrees not to receive any other investigational product or therapy while participating in this study.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Subjects must not receive concurrent or prior use of an immunosuppressive agent within 14 days of the first dose of investigational agent, with the following exceptions and notes:
Subjects must not have received another investigational agent within the shorter of 4 weeks or 5 half-lives before the first dose of investigational agent.
Known intolerance to pritelivir or any of the excipients and 12. Having received an investigational drug in an investigational drug trial within the last 30 days before Day 1 for this clinical trial (except for subjects entering Part B who have previously received foscarnet treatment in Part A of this trial). Participation in a clinical trial without receiving other investigational drugs (e.g. follow-up phase of a trial, observational study) is permitted.
Prior exposure to azacitidine, decitabine or investigational hypomethylating agent
Participation in another clinical study with an investigational product during the last 21 days
Treatment with a prior investigational agent within 30 days of planned instillation of NanoPac®, with the exception of subjects participating in poly (ADP-ribose) polymerase (PARP) inhibitor trials. These subjects must discontinue the investigational agent prior to surgery
Planned participation in another study of an investigational agent or investigational device or use of a therapeutic device intended for therapy of glioma
Has received an investigational product within the 30 days prior to Lymphoseek administration
Has received investigational drugs suspected to cause peripheral neuropathy; no concurrent investigational drugs may be used
Patient has completed participation in another clinical study involving administration of an investigational agent in the preceding 4 weeks. However, participation in clinical studies involving other investigational PET or SPECT tracers will not be excluded if in the opinion of the Investigator:
use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)
Patient included in another clinical trial involving an IMP within 30 days before the first investigational contrast agent injection.
Be informed of the investigational nature of this study
NORMAL VOLUNTEERS: Be informed of the investigational nature of this study
Patients with the use of any investigational product or device, excluding fluorodopa (F-DOPA) scans, within 30 days prior to dosing
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment* (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Administration of any investigational therapeutic within 30 days of enrollment
At the time of registration, all subjects must be removed >= 28 days from any investigational agents
Received an investigational agent within 30 days prior to enrollment
Use of an investigational agent within 4 weeks of enrollment
May have received treatment with an investigational product.
Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration
Patient is participating in a clinical trial of another investigational drug or device
Have taken an investigational drug within 30 days of enrollment.
Known Stage IV ovarian cancer with brain metastases 14. Received an investigational agent in another clinical trial within 30 days prior to surgery 15. Known sensitivity to fluorescent light
Treatment with any investigational product within 30 days before the first infusion.
Investigational drugs: must not be receiving other investigational (from other studies) drugs at time of enrollment and must not be planning to take other investigational drugs during DLT period
Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1
The patient participated in another clinical investigation within 30 days of enrollment or is receiving another investigational agent.
Subjects who have taken an investigational drug within 30 days of enrollment.
Receipt of an investigational drug or device within 30 days of enrollment.
Patients who have been treated with chemotherapy, with biological therapy or other investigational agent must have discontinued the treatment at least 2 weeks (14 days) prior to starting the study drug on Study Day -
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
Other investigational drugs
The participant is receiving any other investigational agent(s).
The participant is receiving any other investigational agent(s).
Subjects who have taken an investigational drug within 30 days of enrollment.
No investigational agent within 4 weeks prior to first dose of study drug
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrolment
Treatment with other investigational agents less than 14 days prior to study entry.