Prior treatment with napabucasin.
Prior treatment with TRC105
PRIOR TREATMENT
Patients must have adequate hematologic, liver and renal function =< 28 days prior to randomization\r\n* NOTE: It is preferred that laboratory values for eligibility be assessed after the last dose of prior treatment, especially in cases where most-recent treatment prior to study entry is chemotherapy
Patients with prior treatment with PLD
Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment
Patient has not had prior treatment with blinatumomab
Previous steroid treatment and/or radiation treatment is not allowed unless it is for the emergent management of a mediastinal mass; emergent steroid treatment and/or radiation treatment should stop once protocol therapy is initiated
No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process; only one cycle is allowed
Prior treatment with brentuximab in the last 6 months or had refractory or progressive disease to prior BV treatment
At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity
Prior treatment with PM01183, topotecan or anthracyclines.
Prior treatment with alisertib
Prior treatment with PM01183 or trabectedin
prior treatment failure with at least two cycles of hypomethylating agent.
Patients must not have received prior treatment with inotuzumab ozogamicin; previous treatment with other anti-CD22 antibodies must have been completed at least 90 days prior to registration
Treatment before study with
Treatment before study with
Prior treatment with systemic chemotherapy for bladder cancer. (Prior intravesical treatment is allowed.)
Past, current or planned treatment with tumor treatment fields; oncolytic viral treatment; or prior exposure to an investigational agent or device within 28 days of receiving the first dose of treatment;
Prior RT or clinically relevant major surgery (e.g. craniotomy, metastasectomy) within 2 weeks prior to first day of study treatment (for treatment phase)
Prior treatment with venetoclax
Any prior intra-lesional MCC therapy within 180 days from day 1 of study treatment
Clinical conditions requiring treatment with oral or parenteral anticoagulants or antiplatelet agents unless treatment can be discontinued 7 days (or 5 half-lives) prior to initiation of study treatment (except used as flushes for indwelling catheters)
Patients must be willing to donate a small amount of whole blood prior to treatment and during treatment for laboratory analysis
Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment
For obinutuzumab in combination with polatuzumab vedotin and lenalidomide (G + Pola + Len) treatment group: R/R FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
Prior treatment with the same agent or combination as the study drug; prior treatment in monotherapy when treated in one of the combination arms in the study is allowed
No prior systemic treatment is allowed, except for subjects in the phase I cohort who are permitted one prior systemic treatment
Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
Any prior treatment with taxotere or carboplatin
Prior treatment with nab-P for the treatment of metastatic disease.
Prior treatment with radiopharmaceutical including radium-223, strontium-89, or samarium-153
Prior treatment with ziv-aflibercept is not allowed
No prior treatment with ONC201.
Participants with prostate cancer who are unable to interrupt treatment with ketoconazole; ketoconazole treatment must be discontinued 2 weeks prior to first dose of study medication and is not allowed during Cycle 1, but may be used in the optional extension phase.
No prior treatment for CAH/EIN/EC
Agreement to biopsies before and during treatment, depending on study part
Prior treatment with SGN-LIV1A or prior treatment with an MMAE-containing therapy
Prior treatment with flutamide (Eulexin®), steroidal anti-androgens (e.g., cyproterone acetate, chlormadinone acetate), androgens, or estrogens treatment within 4 weeks of Cycle 1, Day 1
Participant has received or will receive some form of treatment for their cancer prior to completing a minimum of 14 days of study agent dosing; (a biopsy is not considered a form of treatment)
Prior treatment as follows:
Cytoreduction allowed with hydroxyurea and/or leukapheresis for up to 14 days prior to day (D)1 of treatment under LCCC1522; patients must be off hydroxyurea for >= 12 hours prior to D1 of treatment under LCCC1522
Consent for on-treatment paired biopsies
Willingness to have pre treatment and on treatment tumor biopsies.
Treatment with colchicine is excluded.
Prior treatment with afatinib
Having received treatment in another clinical study within the 30 days prior to commencing study treatment or having side effects of a prior study drug that are not recovered to grade ? 1 or baseline, except for alopecia
Patients may have received treatment of completely resected early stage melanoma, comprising interferon, radiation treatment, or experimental vaccine therapy, and in the metastatic setting patient can have had treatment such as chemotherapy, immunotherapy (except prior treatment with ipilimumab and IL-2), and other experimental agent which was completed 4 weeks prior to enrollment
Prior treatment with compounds with the same mode of action
History of changes in baseline LVEF that occurred during prior treatment with anti-HER2 treatment
For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL. Cohort 8: Received prior treatment with bendamustine and did not respond during treatment or relapsed less than sex months after completing treatment.
No prior therapies are allowed for the treatment of the newly diagnosed breast cancer; patients with a prior diagnosis of malignancy treated >= 5 years ago are eligible, provided that they have not received prior taxanes or carboplatin as part of their prior treatment regimen, and that they meet all eligibility criteria
Patients should be > 24 hours from radiation therapy (RT) treatment to areas of the neuro-axis and all effects of treatment should have resolved
Treatment indicated based on demonstration of at least one of the following no more than 4 weeks from the time of enrollment, and no less than 6 months after prior purine analog and no less than 4 weeks after other prior treatment, if applicable
TREATMENT WITH SJCAR19: Detectable disease
Prior history of treatment with blinatumomab
No prior treatment with temozolomide
Prior treatment with ixazomib
Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to randomization.
Treatment with prohibited medications (concurrent anticancer therapy including chemotherapy, radiation, hormonal treatment [except corticosteroids and megesterolacetate], or immunotherapy) =< 14 days prior to treatment with osimertinib
Had prior treatment with Gliadel
Must be agreeable to the mandatory research tumor biopsies (pre-treatment and on-treatment); tumor biopsies are mandatory at pre-treatment and at on-treatment; there is an optional biopsy at post-progression
Prior treatment with NKTR-102.
Extensive concurrent perianal or lower vulvar HSIL or condyloma requiring a different treatment modality than the study treatment, or treatment that cannot be deferred in observation arm, per examining provider
Radiotherapy (except for brain and extremities or stereotactic treatment) within the past 2 weeks prior to treatment with the trial drug
Prior treatment with nintedanib (BIBF1120)
Any prior treatment for SCCHN
Prior treatment with TAS-102
Treatment with prohibited medications (including concurrent anticancer therapy including chemotherapy, radiation, hormonal treatment [except corticosteroids and megestrol acetate]) =< 14 days prior to treatment
Prior treatment as follows:
Subjects can be treatment naive or may have had two prior regimens for recurrent cancer. They must be naive to treatment with PD-1/L1 or CTLA-4 inhibitors.
Prior yttrium-90 radioembolization treatment
Prior treatment with pazopanib
prior treatment as follows:
Prior treatment with murine and hu3F8 is allowed
Prior treatment with carotuximab (TRC105)
No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator’s opinion
Subjects must not have implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator’s opinion
No endoluminal stent in place at the time of treatment
FOR ALL PHASES (Ib AND II): Concurrent treatment with postmenopausal hormone replacement therapy; prior treatment must be stopped for at least 28 days prior to first baseline biopsy
No restrictions on prior treatment to be eligible
Unable to have TraceIT hydrogel placement < 8 weeks prior to beginning radiation treatment
Abstinence from all manner of physical contact near the treatment area during and up to 2 weeks after the treatment phase.
Elective surgery for treatment of the cutaneous metastases during the study and up to 4 weeks after the treatment period. Cutaneous metastases are required to remain in-situ and measurable for up to 2 weeks after last treatment to achieve study objectives;
No prior treatment with ONC201
At time of day 1 of protocol treatment, subjects with central nervous system metastases must have been treated and must be asymptomatic and meet the following:\r\n* No concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids\r\n* Neurologic stability (lack of signs and symptoms greater than baseline prior to x-ray therapy [XRT]) until the time of dosing\r\n* For radiation treatment, patients must not receive stereotactic radiosurgery or gamma knife treatment within 7 days of day 1 of protocol treatment; for whole brain radiotherapy (WBRT), there should be at least 28 days between last day of WBRT and day 1 of protocol treatment\r\n* Note: patients with leptomeningeal disease or cord compression are excluded from the study
Prolonged antibiotic treatment (>= 10 days, within 3 weeks of enrollment) as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing anti anaerobic antibiotics
Prior treatment with trabectedin
Participant has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for Myelodysplastic Syndrome is allowed except for use of cytarabine.
Not suitable for SBRT treatment
Patient who has had prior treatment with mistletoe
Be receiving leflunomide, or artesunate when study treatment is initiated. Note: Subjects who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Subjects receiving artesunate must discontinue the use prior to the first dose of study treatment.
Prior treatment with all-trans retinoic acid (ATRA) or systemic retinoid for the treatment of hematologic malignancy.
Patients may concurrently receive bisphosphonates or rank ligand inhibitors while on this study if necessary for treatment or prevention of osteopenia or osteoporosis; prior treatment with LHRH agonists is allowed for premenopausal women; topical vaginal estrogen therapy is allowable
Prior treatment with DCC-2618
Prior treatment with any LAG-3 targeting biologic or small molecule
No prior treatment with carmustine wafers
Prior treatment with fosbretabulin is allowed, if not given in combination with everolimus
Prior treatment with lenvatinib
Active treatment for VTE
Dose expansion - KRAS mutant patients groups: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. BRAF mutant patients group: Prior treatment with an ERKi and/or a pan-RAFi.
Cardiac testing with either exercise stress test or thallium stress test, within 3 months of start of the first treatment day; atrial fibrillation that is rate controlled is allowed; note – the first treatment day is about 9 weeks before the first IL-2 treatment day; if a cardiologist’s evaluation determines that this is superfluous based on other assessments, then this may be omitted
Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities and may be enrolled only with increased monitoring: i) prior treatment with anthracyclines; ii) prior treatment with trastuzumab; iii) a New York Heart Association classification of II controlled with treatment; iv) prior central thoracic radiation therapy (RT), including RT to the heart
Phase II mandatory pre-treatment and post-treatment fresh biopsies to determine PD-L1 and EGFR expression and other biomarkers
Prior treatment with temozolomide, dacarbazine or procarbazine
Treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug
Hyperleukocytosis with > 50,000 blasts/ul; hydroxyurea for blast count control is permitted before starting treatment, but must be stopped prior to starting treatment on the study; patients will be withdrawn from the study if > 50,000 blasts/ul occur or recur > 14 days after starting treatment on the study
Is not interested in surgical treatment of her DCIS
Patients having received prior radiotherapy, treatment with cytotoxic agents, treatment with biologic agents or any anti-cancer therapy for a non-AML malignancy within the 4 weeks prior to treatment with selinexor, or those who have not fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment)
Treatment with radiation therapy within 12 weeks prior to the first dose of study treatment, unless there is tissue confirmation of tumor recurrence or there is progression outside the treatment field
Received prior treatment or receiving current treatment for this malignancy
Have failed prior treatment within 6 months of consent date
Any prior treatment with: ipilimumab
Planned treatment with TTFields therapy.
In first or subsequent relapse, or refractory to the last treatment (defined as less than a complete metabolic response to the last treatment, or within 6 months from the last treatment).
Treatment with plasmapheresis within 4 weeks prior to event 1
Prior treatment for endometrial cancer
The subject must agree to 4 months (120 days) of neoadjuvant treatment with TAK-228 and letrozole, have blood draws and urine samples obtained, have research tumor biopsies performed at baseline and after 10 days of TAK-228 treatment, and have a repeat MRI performed prior to surgery (MRI is part of routine clinical care)
Patients must require systemic treatment
Male who is expecting to father a child during the treatment period
Prior treatment with anthracyclines
No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator’s opinion
Either: \r\n* Relapsed after or refractory to prior treatment with at least two regimens or lines of treatment\r\n* Prior failure of at least one regimen or line of treatment, with poor cytogenetic or other risk factors, and ineligible for other clinical trials
Prior treatment with an Murine Double Minute 2 (MDM2) antagonist
Must consent to study-specific biopsies at two separate timepoints: pre-treatment (Screening) and post-treatment (Day 28 or EOS).
Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
Have current second malignancy at other sites, which requires treatment, or in the judgement of the Investigator, may require treatment within the next year. Concurrent malignancies that do not require treatment and are clinically stable are allowed. A past history of other malignancies is allowed as long as the subject is not receiving specific treatment other than hormonal therapy, and, in the judgement of the Investigator, is unlikely to have a recurrence.
Prior surgical treatment of the area (i.e., revision cases); a biopsy does not constitute prior surgical treatment
Prior treatment with leflunomide
Prior treatment with TRC105
Received ? 1 typical regime for the treatment of ITP. Splenectomy is considered one standard ITP treatment
Treatment with IVIG ? 14 days prior to the first dose of PRTX-100
Treatment with an anti-Rh D antigen agent (e.g. WinPho) ? 14 days prior to the first dose of PRTX-100
Prior treatment with crenolanib with progression on treatment
Prior treatment with copanlisib
Planned ongoing treatment with other drugs thought to potentially adversely interact with study drugs; if such medications have been used, patients must be off of these agents for >= 2 weeks prior to initiation of treatment:\r\n* Anticoagulants at therapeutic doses\r\n* Immunosuppressants such as tacrolimus, leflunomide or tofacitinib, roflumilast, pimecrolimus
Patients must agree to pre- and post-treatment biopsies
Prior treatment with topotecan.
Prior treatment with cytotoxic and biological agents is permissible; there should be at least a 2-week break between prior treatment and the protocol treatment
The surgical treatment must be intended to be a lumpectomy
Have body temperature >101ºF (38.3ºC) immediately prior to study treatment.
Concomitant administration of investigational drugs is not allowed; if investigational drugs were given, their use should be completed as guided by that protocol prior to initiation of cytoreduction on this protocol; if the patient is being treated for secondary (treatment related) myelodysplasia after treatment for a non-hematologic malignancy (e.g. Sarcoma), the primary disease should be in remission for at least 6 months after completing primary therapy; patients with secondary myelodysplasia after treatment of a lymphoma, may proceed with treatment with the lymphoma responding or stable but not progressing
Patient who has had prior treatment with demethylating agents
Patient receiving treatment likely to cause hemolysis or under phenytoin treatment.
Only patients that have not received any prior treatment for pancreas cancer are eligible for this treatment protocol
Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
RANDOMIZED PHASE II (ARMS K AND L): Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
Prior treatment with capecitabine or lapatinib
Prior treatment with omacetaxine
Endoscopic and surgical treatment to be provided by same team
Prior treatment with eribulin
Patients must not have had prior treatment with floxuridine (FUDR)
Prior history of treatment with ponatinib
Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment.
TREATMENT:
No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator’s opinion
Greater than 2 weeks since last treatment (chemotherapy or radiation) provided subject has recovered from side effects of treatment prior to the study
No planned systemic treatment is allowed within one week after treatment
Febrile neutropenia or serious persistent infection within 2 weeks prior to Day 1 of treatment
Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
Prior Temozolomide treatment
Patients should have normal coagulation [International Normalized Ratio (INR) < 1.3] and be able to withhold anticoagulation/antiplatelet medications a minimum of 24 hours prior to radiosurgery treatment (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery treatment has concluded.
Treatment with chronic immunosuppressants
Change in the symptomatic treatment of mastocytosis or administration of any new treatment of mastocytosis within 4 weeks prior to baseline
Had prior treatment with napabucasin.
No prior treatment with wee1 kinase inhibition
Prior treatment with sipuleucel-t and Ra-223 is permitted, provided there has been a two-week washout from the last dose
Prior treatment with SERMs or SERDs within 5 weeks of first G1T48 dose
Dose level 2 (20 mg) and higher: willing to provide baseline and on treatment tumor biopsies (3 weeks after RXDX-106 treatment initiation), provided the procedure is clinically feasible and not deemed unsafe by the investigator.
Using any systemic treatment for BCC (e.g. vismodegib), or any topical treatment for their BCC tumors, unless discontinued at least one month prior
Prior treatment with trabectedin or trabectedin analog
Previous treatment with cetuximab with evidence of clinical benefit, as defined by complete response, partial response, or prolonged stable disease with 16 or more weeks of treatment without radiographic progression, as assessed by the treating physician and documented in the medical record; this treatment may have occurred at any point in the patient’s clinical course for treatment of metastatic colorectal cancer
Hydroxyurea within 48 hours prior to first day of study treatment.
Prior treatment for study indication with:
Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. NOTE: Subjects who may be receiving leflunomide or letermovir must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Subjects receiving artesunate must discontinue the use prior to the first dose of study treatment.
Prior treatment with guadecitabine.
Patients must have baseline MRI performed within the 21 days prior to starting treatment
Patients with prior treatment with hypomethylating agents
Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to the expansion cohort, treatment naive arm; if prior (neo)adjuvant treatment given as part of a clinical trial, this would be allowed as long as last dose was > 1 year prior to start of treatment
Prior treatment with fluoropyrimidines (applicable to Part 1 only)
Has prior treatment with Gliadel unless it was administered as first line treatment and at least 3 months prior to study treatment
Prior treatment, involving interferon, anakinra, imatinib, steroids, chemotherapy with, but not limited to cladribine, vinblastine, 6-mercaptopurine and etoposide, or other medications used empirically for the treatment of ECD, will be acceptable; these therapies should have been completed and discontinued 4 weeks or more prior to enrollment in this study
Prior treatment with TPI 287
No implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and treatment delivery
Time from last anti-tumor treatment to first radiation treatment at least 1 week
Prior treatment with radium-223
Treatment with chronic immunosuppressants
Patients who have been off of FOLFIRINOX more than 70 days prior to treatment on study
Prior treatment with Erwinaze
Prior treatment with any cytotoxic chemotherapy for treatment of pancreatic cancer except as an adjuvant therapy; patient should not have received gemcitabine within 6 months of starting the study treatment; 5-flourouracil or radiation treatment should be received more than 4 weeks prior to receiving the study drug
Prior treatment with dasatinib, imatinib or nilotinib
At least 7 days must have passed since the last treatment with lenalidomide, pomalidomide, thalidomide, proteasome inhibitors, or low dose cyclophosphamide (up to 50 mg daily), at least 21 days must have passed since the last treatment with daratumumab, elotuzumab, investigational therapy and most conventional chemotherapy including cyclophosphamide, bendamustine, doxorubicin, cisplatin, and etoposide; and at least 35 days since the last treatment with melphalan
Study participants must have completed any prior treatment at least 3 weeks prior to treatment on this protocol; prior treatments may have included chemotherapy however may not have included BRAF or MEK inhibitors or immunotherapies (interleukin-2, ipilimumab, anti-programmed death [PD]1 antibodies etc.) excluding vaccine therapy; prior treatment with interferon in the adjuvant setting is allowed, though prior treatment with ipilimumab in the adjuvant setting is not; prior radiation therapy is allowed though must have included no more than 3000 centigray (cGy) to fields including substantial marrow
Current treatment or treatment within 4 weeks of screening with bisphosphonates.
AT TIME OF TREATMENT:
AT TIME OF TREATMENT:
No prior treatment with LMB-2
Prior treatment with IMGN853
Prior treatment with adenovirus-based drugs
Patients undergoing pre-treatment surgery for purposes other than cytoreduction may also participate provided they meet eligibility; patients randomized to arms containing bevacizumab must wait a minimum of 28 days since that procedure to begin protocol treatment; patients who undergo an uncomplicated port placement must wait a minimum of 7 days to begin protocol treatment
Prior treatment with quizartinib or participated in a prior quizartinib study.
Prior treatment with imetelstat
Prior treatment with eribulin
They have other medical problems that could get much worse with this treatment.
Planned treatment with biological agents within 28 days prior to receiving TheraSphere (may resume after Y-90 treatment or immediately if in control arm)
Treatment with chemotherapy less than or equal to (</=) 3 weeks before study treatment
Treatment with biologic therapy </= 3 weeks before study treatment
Adequate recovery from most recent systemic or local treatment for cancer
Prior treatment with TRC105
Prior treatment with prolifeprospan 20 with carmustine wafer.
Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
Patients must not have received any treatment after discontinuing MEDI4736 with the following exceptions; localized palliative radiation therapy is allowed for symptom management, provided and treatment is completed >= 14 days prior to RE-TREATMENT registration; local treatment for brain metastases is allowed
Willingness to provide pretreatment and on-treatment biopsies.
Prior treatment with entrectinib.
Prior treatment with PM01183 or trabectedin.
Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
Prior treatment with nintedanib
No prior treatment except patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids, cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture
No prior systemic treatment for ES-SCLC
Prior treatment with either BBI608 or BBI503
Prior treatment with rigosertib;
Treatment with other locoregional therapies (other than study treatment) has not been planned for the duration of the clinical study period
Prior treatment with transarterial chemoembolization (TACE) or bland embolization >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol
Prior treatment with plitidepsin.
All patients who disagree to refrain from donating blood while on study treatment and for 4 weeks after discontinuation from this study treatment.
Prior treatment with lenvatinib.
Live vaccines should ideally not be administered to any patients undergoing treatment with chemotherapy or immunotherapy, but if need be, they should be administered >4 months prior to the initiation of treatment or >4 months after the completion of all treatment
Has prior treatment with Gliadel (carmustine) unless it was administered as first line treatment and at least 3 months prior to study treatment
On treatment with eculizumab (Soliris®) for at least 3 months
Prior treatment with temozolomide, dacarbazine or procarbazine
Ongoing treatment with chronic immunosuppressants.
Treatment-naïve
TREATMENT
TREATMENT
Patients may have had prior adjuvant treatment for colorectal cancer; the prior treatment regimen must not have included bevacizumab but may have included oxaliplatin and the last dose of chemotherapy must have been > 6 months prior to study entry; patients with prior radiotherapy are acceptable; it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated
Prior treatment with other agents targeting the HGF/c-Met pathway
Preemptive treatment with retinoic acid prior to exclusion of APL ? 7 days
Prior treatment with IMGN779
Prior treatment with neratinib
Prior treatment with imetelstat
Prior treatment with letrozole is allowed if the patient meets the washout period of 10 days.
Treatment with short-acting somatostatin analogs less than 3 days and Sandostatin depot injection less than 5 weeks before scanning and treatment
No prior treatment with carmustine wafers
Chronic treatment with glucocorticoids within one year
Patients may have had prior chemotherapy or immunotherapy or radiation therapy; all prior therapies must be stopped 4 weeks prior to first dose of study treatment, with the exception of patients who have received ipilimumab, which must be stopped 6 weeks prior to first dose of study treatment; patients are prohibited from receiving live vaccines within 30 days prior to first dose of study treatment
Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.
Actively breastfeeding women unless it is interrupted during treatment and at least 6 weeks after treatment discontinuation
Prior treatment with dasatinib
Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.
ELIGIBILITY FOR TREATMENT ON ARM 1: Ninety days must have passed since the last doses of radiation or chemoradiation treatment involving lung tissue or thorax prior to T cell infusion (to avoid confounding pneumonitis)
ELIGIBILITY FOR TREATMENT ON ARM 2: Ninety days must have passed since the last definitive doses of radiation or chemoradiation treatment prior to T cell infusion (to avoid confounding pneumonitis)
Patients willing to have regular blood draws, one before treatment and four during or after treatment
Current treatment or known prior treatment with ribavirin
Prior treatment with bosutinib.
Prior treatment with ponatinib.
Prior treatment with MMB
Prior treatment with bortezomib
Prior treatment with BBI608.
Prior treatment with radium-223 dichloride
History of prior venetoclax treatment
Prior treatment according to protocol-defined criteria
Preemptive treatment with retinoic acid prior to exclusion of APL ? 7 days;
Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosphonates are permitted without restriction even during protocol treatment.
Prior treatment with second generation anti-androgens
The most recent treatment prior to enrollment must be one of the following (duration of treatment >= 2 weeks), and must have been adequately tolerated according to the treating physician's judgment\r\n* Letrozole\r\n* Exemestane\r\n* Exemestane + everolimus (everolimus must be discontinued for >= 3 weeks prior to starting study treatment)\r\n* Letrozole or exemestane in combination with an experimental agent(s) on a clinical trial, provided that the experimental agent(s) is not a PI3K inhibitor or v-akt murine thymoma viral oncogene homolog 1 (AKT) inhibitor (experiment agent[s] must be discontinued for >= 3 weeks prior to starting study treatment)
Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from placement
Treatment naïve patients
Prior treatment with eribulin
Subjects may be receiving anti-cancer treatment, but this treatment should be have been instituted at least 4 weeks prior to enrollment, and may not change during the study period
Prior treatment with letrozole is allowed
Prior treatment with pemetrexed < 6 months prior to starting study drug
Prior treatment with KW-0761 or vorinostat.
Prior treatment with an anti-angiogenic agent is not an exclusion criterion.
Prior treatment with Alpharadin® (Xofigo®)
Within 2 weeks of treatment initiation (day 0), have received at or adjacent to the target treatment lesions:\r\n* Any surgical procedures other than biopsies related to CTCL diagnosis or follow up\r\n* Any topical treatment other than bland moisturizers (creams, lotions, emollients, etc)
Have other concurrent cutaneous conditions in the treatment area or immediately adjacent to the treatment area that would be exacerbated by resiquimod or interfere with assessments
Prior crenolanib treatment for a non-leukemic indication
Patients must not have prior, current or planned treatment as defined below:\r\n* Previous treatment with > 2 anticancer regimens\r\n* Any prior radiotherapy to the pelvis or abdomen\r\n* Surgery (including open biopsy) within 4 weeks prior to the start of study, or anticipation of the need for major surgery during study treatment\r\n* Minor surgery procedures, within 24 hours prior to the first study treatment\r\n* Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (> 325 mg/day)\r\n* Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study\r\n* Chronic daily treatment with corticosteroids (dose > 10 mg/day methylprednisolone equivalent), excluding inhaled steroids
Prior treatment with eribulin
Complete initial work-up within 8 days prior to treatment that allows definite staging
Prior bevacizumab as 1st line treatment for GB (if treatment was concluded 12 months prior to enrollment, the patient may be eligible to participate in the trial)
Prior therapies for treatment of HL including involved field radiation therapy or any prior treatment for any malignancy with anthracyclines
Currently benefitting from continued treatment and have an acceptable safety profile with GSK2110183 as determined by the investigator following previous treatment with GSK2110183 either as monotherapy or as part of a combination treatment regimen.
Complete initial work-up within 8 days prior to treatment that allows definite staging.
Either no previous trans-hepatic arterial treatment or progressive hepatic metastasis after prior regional treatment with trans-arterial embolization; embolization of hepatic artery with different types of medication will be considered to be one regional treatment
For patients with MPN: Ruxolitinib treatment requirements will be waived for patients who have failed this treatment in the past or for whom this treatment is otherwise contraindicated
Prior treatment with radiosurgery
Has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form.
Prior treatment with treatment doses of capecitabine (prior radio-sensitizing doses of capecitabine are allowed as long as the patient did not progress on capecitabine)
The above tests must be obtained within 14 days of study treatment
Patients must have an indication for treatment by 2008 IWCLL Criteria
Prior treatment with MDV3100
Prior treatment with ketoconazole
Prior treatment with HAI FUDR
a. Indication A - ASPS: Prior treatment with cediranib.
Patients must have achieved PR to primary treatment and not be refractory to prior treatment
Treatment must begin within 90 days of the last dose of immunochemotherapy
Less than 28 days since last treatment used to treat the disease
Prior history of treatment with dasatinib
Prior treatment with temozolomide, dacarbazine or procarbazine.
Osteoporosis requiring treatment at the time of randomization or treatment considered likely to become necessary within the subsequent six months
Study treatment must begin within 30 days of surgical resection or adjuvant treatment; this timeline may be extended if further time for recovery from treatment related toxicities is required
Prior treatment with cabazitaxel
Prior treatment with pacritinib
Prior treatment with bortezomib
Prior treatment with TPI 287
Patients should NOT have had prior therapy for primary myelofibrosis. This includes treatment with cytoreductive drugs (Hydroxyurea), immunomodulatory drugs (thalidomide, lenalidomide, pomalidomide), JAK2 inhibitors, or other therapies specifically for myelofibrosis. If they received these classes of drugs for indications other than PMF, treatment should be discontinued at least 6 weeks prior to randomization.
Prior treatment with drugs of the immunotoxin class
TREATMENT:
Prior treatment with AN-152
Participants may be treatment naive, refractory to or intolerant of one or more prior therapies, or treated with prior systemic treatment including but not limited to liposomal doxorubicin
Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment.
Prior treatment with bicalutamide will not be allowed
Patients may have had treatment for an unlimited number of prior relapses
Serum cholesterol < ULN with or without treatment for hyperlipidemia; if > ULN and untreated, may be rescreened for eligibility after treatment
Prior treatment with MMB
Prior treatment with TNFRSF agonists.
Prior treatment with more than 3 lines of cytostatic therapies for metastatic disease unless specifically agreed between investigator and sponsor. Subjects with a history of any prior Grade =/> 3 toxicity associated with taxane treatment will be excluded.
Prior treatment with interferon alfa is allowed
Requires initiation of daily PE treatment and has received 1 PE treatment prior to randomization
Prior sunitinib treatment.
Prior treatment with mirvetuximab soravtansine
Prior treatment with ANG1005/GRN1005
Eligible and agreeable for percutaneous biopsy of a primary or metastatic lesion prior to treatment and after approximately 16 weeks of treatment
Prior treatment with selinexor
Prior crenolanib treatment for a non-leukemic indication
Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
Any prior treatment with topoisomerase I therapy.
Prior treatment with BBI608.
Able to initiate study treatment within 2 weeks of completion of last chemoradiation treatment;
Prior treatment with a compound of the same mechanism
Treatment with interferon within 4 weeks prior to first dose of study treatment
Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF)
Prior HER3- directed treatment (HER2- or EGFR-directed treatment is acceptable).
Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from placement
Prior vemurafenib treatment
Prior treatment with cabazitaxel
Prior history of treatment with ABT-263
Lapatinib =< 14 days before first study treatment
Chemotherapy with approved or investigative anticancer therapeutics including steroid therapy within the three weeks prior to first dose (unless enrolling on this study after progression Cancer Molecular Analysis Project [CMAP] compassionate use carfilzomib protocol, in which case subject may proceed with current study treatment on next expected date of treatment)
Patients receiving treatment with bupropion.
Prior treatment with AEZS-108.
Patients with a history of prior treatment with ipilimumab
Prior treatment with bortezomib (Velcade) is acceptable with a wash-out of 2 weeks
Treatment with ritonavir at the time of first dose of study treatment.
Treatment with a cyclical chemotherapy within a period of time that is less than the cycle length used for that treatment prior to first dose of study treatment.
Treatment with any other investigational agents within a period of time that is less than the cycle length used for the treatment or within 28 days (whichever is shorter) prior to first dose of study treatment.
Prior treatment with TRC105
Patients with a history of prior treatment with ipilimumab or dasatinib
Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
Prior treatment with floxuridine (FUDR)
Prior treatment with HAI floxuridine (FUDR)
Prior treatment with immunomodulators, including toll-like receptor (TLR) agonists, inhibitors of indoleamine 2,3-dioxygenase (IDO)/ tryptophan-2,3-dioxygenase (TDO), or agonists of OX40, is allowed provided that at least 5 half-lives of the drug or a minimum of 3 weeks have elapsed between the last dose of the prior treatment and the proposed Cycle 1, Day 1, with the exception as specified in protocol
Prior treatment with AIs
Patients who are receiving treatment with statins that are known to cause rhabdomyolysis and that cannot be discontinued at least 2 days prior to starting LDE225 treatment
Subjects enrolled into the previously untreated subject cohort must also meet all of the following criteria: No prior treatment for CLL (prior corticosteroid immunosuppression treatment for autoimmune hemolytic anaemia and idiopathic thrombocytopenic purpura (ITP) is permitted); Be considered inappropriate for fludarabine-based therapy for reasons that include, but are not limited to, advanced age or presence of co-morbidities.
Prior treatment with PM01183.
Prior treatment with pazopanib.
Part A2: Unable to swallow tablets. Intolerant of therapy with erlotinib. Concomitant treatment with the cytochrome P450 3A (CYP3A) modulators. Must not have received treatment with any of these modulators within 14 days of study treatment.
Is treatment naive or has received prior treatment for metastatic melanoma.
prior treatment with PF-02341066
Prior treatment with taxanes or anthracyclines is required;
Prior treatment with obinutuzumab
Minimum 3 weeks since prior systematic treatment or phototherapy
Patients who have failed at least one line of a standard treatment, including bendamustine, fludarabine, ibrutinib, or alemtuzumab and require treatment within 2 years of completion of last treatment regimen or untreated with del17p by fluorescence in-situ hybridization (FISH) (high-risk) who do not have an allogeneic stem cell transplant option
Patients must not co-enroll on other treatment trials
CHILD: Child has completed cancer treatment and is up to 7 years post-treatment
Patients receiving non-intensive treatment
>= 6 months post active treatment
Patients who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential.
Documented investigator-assessed relapse or progression after the last treatment is required if the participant responded and then progressed on the prior treatment.
Prior treatment with selinexor
Prior treatment with the Optune® system.
Patients taking Viagra must have a 1 day washout period prior to treatment.\r\n* Note: patients must agree to discontinue Viagra while on study treatment.
Treatment with virus – specific T cells within 6 weeks (42 days) of planned infusion
Planned treatment with any VEGF?TKI treatment with treatment has not yet begun
Provides consent for his/her own treatment and procedures
Anytime from treatment
Has initiated treatment as part of an active St. Jude Children's Research Hospital (SJCRH) treatment plan
Acupuncture treatment in the preceding 4 weeks prior to day 1
6 months post-treatment completion
Off-treatment and progression-free for at least 12 months and =< 14 years; treatment cessation is defined as the final dose of chemotherapy, the last dose (fraction) of radiation, or date of surgery, whichever occurred last
Serum creatinine acceptable for treatment with cisplatin per institutional guidelines
Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 2 years post-treatment
Refusal of any cancer treatment(s)
Six to 36 months post treatment
2 months post treatment
Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
Treatment for hyperleukocytosis with hydroxyurea;
Prior treatment with an agent targeting the exportin
AYA has initial or relapsed cancer diagnosis and is actively on treatment and will continue to be on treatment long enough to complete the intervention and evaluation (4 to 6 weeks)
Planned cisplatin treatment restricted to the following treatment course criteria:\r\n* Dose: > 50 mg/m^2\r\n* Frequency: every (q)3-q4 weeks\r\n* Cycles: 7 maximum
Men randomized to the treatment arm should not father a baby while receiving topical treatment during this study; men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment
No prior history of NMSC in the treatment fields
No actinic keratosis (AK)/Bowen’s disease in the treatment fields within the last 3 months
Exposure to cisplatin treatment without intervention
Prior or concurrent eczema or other eczemoid skin disorders or active skin condition (acute, chronic, or exfoliative) that disrupts the epidermis; persons with psoriasis are not excluded except in cases of:\r\n* any active lesion\r\n* any active lesion in the previous 6 months that required treatment, either systemic or topical\r\n* any prior episode, at any time, extensive enough or severe enough as to require systemic treatment
Treatment with other oral hypoglycemic agents
TREATMENT GROUP
TREATMENT GROUP
As determined by the study investigators or consenting professionals, recent prolonged antibiotic treatment as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing antianaerobic antibiotics
Subjects who received prior treatment or are already receiving everolimus treatment prior to study entry are not eligible.
Patients may have had treatment for no more than 2 prior relapses
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment
Prior treatment with capecitabine
Prior treatment with a drug that targets BCMA on tumor cells or any other bi specific antibody construct or chimeric antigen receptor T cell (CAR-T) infusion for the treatment of multiple myeloma
Be an intestinal cancer survivor that is a minimum of 4 months post chemotherapy/radiation treatment; OR be a healthy adult with no prior history of treatment for cancer
There will be no restrictions on prior treatment
Prior endoscopic treatment for BE
Recipients of more than minimal anti-leukemia treatment, with minimal treatment defined as: leukapheresis, hydroxyurea, or cytarabine more than 1 g per square meter
Prior and current therapy:\r\n* For NF1 related benign tumor manifestations there is no standard effective medical treatment, and surgery is the only standard treatment; chemotherapy and radiation therapy are additional treatment options for malignant NF1 related tumors; for the purpose of this study subjects who have not previously received medical or surgical treatment, patients who have previously received medical or surgical treatment, and subjects who are currently receiving medical treatment and or radiation for a NF1 related manifestation will be eligible\r\n* Patients must be recovered from acute toxicities of prior therapy in order to be able to safely undergo biopsies proposed on the trial; prior and current treatment for NF1 related manifestations will be recorded on protocol 08-C-0079\r\n* Prior radiation therapy and chemotherapy in patients with MPNST must not have been administered within 4 weeks prior to enrollment
Planned total mastectomy for treatment
Allowable type and amount of prior therapy: patients with newly diagnosed malignancies should not have initiated treatment for their disease before participating in this study; patients with recurrent or second malignancies may have had prior therapy as appropriate for their disease, but should have completed all prior treatment at least 30 days before participation in this study and should not have initiated new treatment for the current problem
Patients who have consented to a therapeutic protocol for the treatment of their cancer
Prior treatment
Treatment-naïve/Unfit Cohorts Only: Any prior anti-leukemic therapy (excluding hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low dose cytarabine.
Prior treatment with SL-401
Actively breastfeeding women unless it is interrupted during treatment and at least 6 weeks after treatment discontinuation
Patients 18 years of age and older who are being evaluated for and/or treated for cancer at the NIH Clinical Center or at participating sites:\r\n* Who have a newly diagnosed malignancy for which they have not yet received treatment, or\r\n* Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:\r\n** Radiographic evidence of tumor growth and/or new metastases, or\r\n** Documented evidence by the treating physician of signs/symptoms of clinical disease progression, or\r\n* Who are currently undergoing treatment (adjuvant, neoadjuvant, etc.), are within the first two (2) cycles of treatment, and for whom disease response has not yet been assessed\r\n** In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle\r\n* For matched pair collections only (tissue + blood), patients with ongoing partial response (PR) or stable disease (SD) are eligible\r\n** Confirmation of viable malignancy and/or < 90% tumor necrosis must be confirmed to the coordinating site, as indicated in the final pathology report, for patients enrolled with PR or SD
Prior treatment with sipuleucel-T
No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma
Prior treatment with MORAb-009
Prior treatment with SS1(dsFv)PE38 (SS1P)
Prior treatment with trabectedin
Patients must be registered to the study within 3 working days after being seen by surgical team for MBO or within 3 working days after completion of indicated treatment (e.g. total parenteral nutrition [TPN], anticoagulation reversal) to make them eligible for surgical intervention, whichever is later, and prior to any treatment (surgical or non-surgical) for MBO; treatment is defined as any medication or invasive interventions beyond nasogastric decompression, hydration, pain medications or antiemetic medications; NOTE: somatostatin analogues may be used prior to registration if that use is limited to not more than the two days just prior to registration
Prior treatment with PM060184.
Patients who have initiated treatment for unresectable or metastatic melanoma at\n             medical practice (e.g. community-based, office-based, hospital-based, academic\n             setting)within 21 days before informed consent for this study OR in the case where\n             treatment has not yet been initiated, documentation that the treatment strategy was\n             determined before informed consent for this study, and treatment must be initiated\n             within 28 days after informed consent
Ipilimumab-treated patients must be receiving treatment for the indication(s)\n             approved in their country of residence or where they are receiving treatment
Prior treatment with BLZ-100.
Prior treatment with talimogene laherparepvec or any other oncolytic virus.
Prior treatment with TGR-1202
Prior treatment with lenvatinib.
Prior treatment with TRC105