[c09aa8]: / clusters / 9knumclustersv2 / clust_286.txt

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Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for weeks after the last dose of napabucasin or while undergoing treatment with FOLFIRI and for days after the last dose of FOLFIRI.
Treatment before study with
Treatment before study with
Past, current or planned treatment with tumor treatment fields; oncolytic viral treatment; or prior exposure to an investigational agent or device within days of receiving the first dose of treatment;
Treatment with any of the following:\r\n* Any investigational agents or study drugs from a previous clinical study within days of the first dose of study treatment\r\n* Any other chemotherapy, immunotherapy or anticancer agents within weeks or half lives, whichever is shorter, of the first dose of study treatment, except fulvestrant, enzalutamide or hormonal therapy with LHRH analogues for medical castration in patients with breast or prostate cancer, which are permitted\r\n* Potent inhibitors or inducers or substrates of CYPA or substrates of CYPD within weeks before the first dose of study treatment ( weeks for St John's wort)\r\n* Major surgery (excluding placement of vascular access) within weeks of the first dose of study treatment\r\n* Radiotherapy with a wide field of radiation within weeks of the first dose of study treatment\r\n* AKT inhibitors
Participants cannot have been treated on a prior interventional, investigational study within weeks of the first dose of study treatment
Inclusion Criteria:\n\n Specific criteria for patients who continue treatment as well as safety and survival\n follow-up in the extension study:\n\n - Eligible for continuing or crossing over to atezolizumab-based therapy at the time of\n the parent-study closure as per the parent study or eligible for continuing the\n comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the\n parent-study closure as per the parent study\n\n - First dose of study treatment in the extension study will be received within the\n treatment interruption period allowed by the parent study\n\n - Continue to benefit from atezolizumab-based study treatment or from the comparator at\n the time of parent-study closure as assessed by the investigator\n\n - Negative serum pregnancy test within days prior to start of study treatment in women\n of childbearing potential\n\n Specific criteria for patients who do not continue treatment in the extension study and/or\n receive commercially available atezolizumab (Tecentriq) outside this extension study and\n continue safety and survival follow-up only in the extension study:\n\n - Discontinuation of atezolizumab-based therapy in parent study and in survival follow up\n at the time of parent study closure, or eligible for continuing or crossing over to\n atezolizumab-based therapy as per the parent protocol and have access to commercially\n available atezolizumab (Tecentriq) outside this extension study at the time of the\n parent-study closure\n\n Exclusion Criteria:\n\n Specific criteria for patients who continue treatment as well as safety and survival\n follow-up in the extension study:\n\n - Meet of any of the study treatment discontinuation criteria specified in the parent\n study at the time of enrollment in the extension study\n\n - Study treatment is commercially marketed in the patient's country for the patient\n specific disease and is accessible to the patient\n\n - Time between the last dose of treatment received in parent study and first dose in\n extension study is longer than the interruption period allowed in the parent study\n\n - Treatment with any anti-cancer treatment (other than treatment permitted in the parent\n study) during the time between last treatment in the parent study and the first dose\n of study treatment in the extension study\n\n - Permanent discontinuation of atezolizumab for any reason during the parent study or\n during the time between last treatment in the parent study and the first dose of study\n treatment in the extension study (if applicable)\n\n - Any unresolved or irreversible toxicities during the parent study that required\n permanent discontinuation of study treatment, in accordance to the parent study or\n local prescribing information\n\n - Ongoing SAE(s) that has not resolved to baseline level or Grade less than or equal to\n (<=) from the parent study or during the time between last treatment in the parent\n study and the first dose of study treatment in the extension study\n\n - Any serious uncontrolled concomitant disease that would contraindicate the use of\n study treatment at the time of the extension study or that would place the participant\n at high risk for treatment-related complications\n\n - Concurrent participation in any therapeutic clinical trial (other than the parent\n study)\n\n Specific criteria for patients who do not continue treatment in the extension study and/or\n receive commercially available atezolizumab (Tecentriq) outside this extension study and\n continue safety and survival follow-up only in the extension study:\n\n - Discontinuation of comparator in parent study and in survival follow-up at the time of\n parent study closure
Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within days prior to the first dose of study treatment; or pegylated interferon in the days before the first dose of study treatment
No previous treatment with the specific assigned study drug or any other drug sharing the same target; prior treatment in monotherapy when treated in one of the combination arms in the study is allowed
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
Must not have taken an unapproved drug as treatment for any indication within the last days prior to starting study treatment
Treatment with clarithromycin, anti-myeloma therapy including investigational agents or plasmapheresis within days prior to treatment in this study
Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the weeks ( days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO/TDMg (NCT) at the time of the parent study closure if the participant received the last dose of control arm study drug within the weeks ( days) prior to the first dose of control arm study therapy in the extension study
Participants in the control arm from Study BO/TDMg whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into study TDMg (NCT)
History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's last study drug dose in the parent study
Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for advanced NSCLC used for a previous treatment regimen or clinical study within days of the first dose of study treatment.
Having received treatment in another clinical study within the days prior to commencing study treatment or having side effects of a prior study drug that are not recovered to grade ? or baseline, except for alopecia
Treatment with any investigational compound within days prior to the first dose of study drugs
Treatment with an investigational drug study within days of before starting on study treatment
Any cytotoxic chemotherapy or other anticancer drugs from previous treatment regimen or clinical study within days of first dose of study drug
STUDY TREATMENT: Hemoglobin >= . g/dL within days prior to the first study treatment.
Chemotherapy or radiotherapy within days prior to starting study treatment; in case of monoclonal antibodies/biologics, within days prior to starting study treatment
Women of childbearing potential must use an acceptable form of birth control for days prior to beginning study treatment, through the duration of study treatment, and for months after discontinuing study treatment
Bisphosphonate treatment within days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days to of the -day treatment cycle)
Any of the following clinical laboratory results during screening (i.e., within days before the first dose of study treatment):
Be receiving leflunomide, or artesunate when study treatment is initiated. Note: Subjects who may be receiving leflunomide must discontinue the use at least days prior to randomization at Visit /Day and the first dose of study treatment. Subjects receiving artesunate must discontinue the use prior to the first dose of study treatment.
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within days before the first dose of study treatment
Treatment within days prior to first study treatment with conventional therapy or treatment within days prior to first study treatment with an investigational drug
Hyperleukocytosis with > , 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 > , blasts/ul occur or recur > days after starting treatment on the study
Treatment within the last days with a drug that has not received regulatory approval for any indication at the time of study entry or used an investigational device within weeks of the first dose of treatment
Treatment with radiation therapy within 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
Treatment with any investigational compound within days prior to the first dose of study drugs
Received an immune-suppressive based treatment for any reason within days prior to the first dose of study treatment.
Use of an investigational treatment (except for ibrutinib) from days prior to the first dose
Use of an investigational treatment (except for ibrutinib) from days prior to the first dose
Must not have taken an unapproved drug as treatment for any indication within the last days prior to starting study treatment
Has been permanently discontinued from study treatment in the parent study for any reason.
Prior treatment within days of the first dose of study drug with any other chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment, or failure to recover from adverse effects of prior therapies administered over weeks prior to study day ; all toxicities from prior therapies must be =< grade (or =< grade for alopecia or peripheral neuropathy); prior systemic treatment in the adjuvant setting is allowed
Consumption of agents which strongly inhibit CYPA enzyme, within days prior to the first dose of study treatment and during the study.
Consumption of agents which strongly induce CYPA enzyme, within days prior to the first dose of study treatment and during the study.
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 days prior to randomization at Visit /Day and the first dose of study treatment. Subjects receiving artesunate must discontinue the use prior to the first dose of study treatment.
Patients who have been off of FOLFIRINOX more than days prior to treatment on study
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
Prior treatment with any cytotoxic chemotherapy for treatment of pancreatic cancer except as an adjuvant therapy; patient should not have received gemcitabine within months of starting the study treatment; -flourouracil or radiation treatment should be received more than weeks prior to receiving the study drug
At least days must have passed since the last treatment with lenalidomide, pomalidomide, thalidomide, proteasome inhibitors, or low dose cyclophosphamide (up to mg daily), at least 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 days since the last treatment with melphalan
Platelets >= x ^/L, within weeks of the first dose of study treatment
Treatment with any systemic chemotherapy or investigational agents within weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy
Treatment with chemotherapy less than or equal to (</=) weeks before study treatment
Treatment with biologic therapy </= weeks before study treatment
Discontinued all prior treatment for cancer at least days prior to initial dose of study treatment.
Subject who is receiving or has received any other investigational agents within days prior to day of treatment in this study; in addition, day of the study treatment should be at least days after prior chemotherapy
Treatment with other locoregional therapies (other than study treatment) has not been planned for the duration of the clinical study period
Tamoxifen therapy less than days before first dose of study treatment
Part A, B and C: Fulvestrant therapy less than days before first dose of study treatment. Part D: Fulvestrant therapy less than days before first dose of study treatment
Any cytotoxic chemotherapy,or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen within days of the first dose of study treatment
Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within days of the first dose of study treatment
Other investigational treatment during or within days before starting study treatment
Use of an investigational treatment from days prior to the first dose of SNX- and during the study.
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within days before the first dose of study treatment\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within days before the first dose of study treatment
History of receiving any investigational treatment within days prior to enrollment into the study
Any investigational agents or study drugs from a previous clinical study within days of the first dose of study treatment;
Anticancer treatment (e.g., radiation therapy, chemotherapy) within days of first dose\r\n* An exception is cetuximab treatment, which can be received within days of the first treatment on study.
Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within days of the first dose of study treatment.
Previous exposure to any investigational treatment within days before the first dose of study treatment
Treatment with any anti-cancer investigational drug within days prior to commencing study treatment
Patients must not have prior, current or planned treatment as defined below:\r\n* Previous treatment with > anticancer regimens\r\n* Any prior radiotherapy to the pelvis or abdomen\r\n* Surgery (including open biopsy) within weeks prior to the start of study, or anticipation of the need for major surgery during study treatment\r\n* Minor surgery procedures, within hours prior to the first study treatment\r\n* Current or recent (within days prior to the first study drug dose) chronic daily treatment with aspirin (> mg/day)\r\n* Current or recent treatment with another investigational drug within days of first study treatment dosing or earlier participation in this study\r\n* Chronic daily treatment with corticosteroids (dose > mg/day methylprednisolone equivalent), excluding inhaled steroids
Subjects receiving other investigational agents thirty days prior to study treatment or during treatment
Has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form.
Any unresolved toxicity that meets the study treatment discontinuation or study withdrawal criteria from the parent study at the time of transition to this study.
The above tests must be obtained within days of study treatment
Treatment must begin within days of the last dose of immunochemotherapy
Treatment with any of the following hormone replacement therapies, unless discontinued at least days prior to the first dose of study treatment:
French subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous days.
Study treatment must begin within days of surgical resection or adjuvant treatment; this timeline may be extended if further time for recovery from treatment related toxicities is required
Anti-leukemia treatment within days of study drug (other than hydroxyurea or -mercaptopurine), immunosuppressive therapy (except for GVHD treatment/prophylaxis in Part B), or investigational agents
Receiving any other therapies for cancer treatment (with the exception of gonadotropin-releasing hormone [GnRH] agonists for prostate cancer); Note: hydroxyurea is allowed before initiation of study treatment and for the first days of study treatment
Severe infections within days prior to the first dose of study treatment
Received an immune-suppressive based treatment for any reason within days prior to the first dose of study treatment.
Must not have taken an unapproved drug as treatment for any indication within the last days prior to starting study treatment.
Treatment with interferon within weeks prior to first dose of study treatment
Antileukemia treatment within days of study drug (other than hydroxyurea or -mercaptopurine)
French subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous days.
Chemotherapy =< days before first study treatment
Trastuzumab =< days before first study treatment
Lapatinib =< days before first study treatment
Focal radiation therapy within weeks before first dose of study treatment, or full spinal radiotherapy within months before first dose of study treatment.
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 days (whichever is shorter) prior to first dose of study treatment.
Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within weeks of initial study treatment
Administration of an investigational study treatment within days preceding the first dose of study treatment(s) in this study.
The patient has received any investigational or non-registered medicinal product other than the study treat-ment within days preceding the first dose of study treatment or plans to receive such a drug during the study period.
Subject must be receiving a stable dose of ASP for days minimum and is able to enroll into this rollover study without treatment interruption of study drug, or with no more than consecutive days of treatment interruption in study drug within the parent study.
Plan to be on chemotherapy or other allowable treatment for at least months (minimum days) and be willing to come in for study visits\r\n* The plan for treatment should be for at least months at time of study enrollment; the treatment can stop earlier during the study at the discretion of the physician and patient (e.g., due to progression as noted through imaging, toxicity, or patient preference)
Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within months after the last dose of study treatment
Recipient of vaccines within month of or during study drug treatment.
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 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 days after informed consent