Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
Patients may have received one and only one cycle of chemotherapy prior to enrolling on Cancer and Leukemia Group B (CALGB) 30610, which must have included carboplatin or cisplatin and etoposide; if a patient has had one cycle of cisplatin (or carboplatin)/etoposide prior to registration, the patient must have had all of the prior to registration tests prior to starting their first cycle of chemotherapy; additionally, these patients also must have met all of the eligibility criteria prior to receiving the first cycle of chemotherapy; registration to CALGB 30610 must take place within 7-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB 30610
Patients must not have unequivocal disease progression (by RECIST v1.1) during the first cycle; patients must have disease assessed using the same method as baseline within +/- 5 days of the day 56 scheduled assessment (between days 51-55 of cycle 1, or days 1-5 of cycle 2); all disease must be assessed and documented on the follow-up tumor assessment form (RECIST 1.1)
Patients must be registered to step 2: randomization within +/- 5 days of starting cycle 2; patients MUST NOT be registered prior to the day 56 disease assessment
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than: Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ? 4 weeks prior to Cycle 1 Day -2). One line of cytotoxic chemotherapy (must be completed ? 4 weeks prior to Cycle 1 Day -2). Adjuvant/neoadjuvant radiotherapy (must be completed ? 12 months prior to Cycle 1 Day -2, with field not involving > 10% of bone marrow reserve).
Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational anti-cancer agents or biologic therapy for the disease under study. Single non-target lesion irradiation with intent of symptom palliation is allowed if ? 4 weeks prior Cycle 1 Day -2.
Previous treatment with radiotherapy or immunotherapeutic agents in the 4 weeks prior to study drug administration (Cycle 1 Day 1)
Use of immunosuppressant medications in the 2 weeks prior to study drug administration (Cycle 1 Day 1)
Prior therapy with immune-activating agents within less than 1 cycle length prior to first day of study treatment (e.g. 3 weeks for ipilimumab or pembrolizumab; 2 weeks for nivolumab) (for treatment phase)
Any other systemic or regional anticancer therapy (cytotoxic chemotherapy, embolization) within 3 weeks or 1 cycle length, whichever is shorter, prior to first day of study treatment (for treatment phase)
Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor (CAR) T cells directed against B cells within 8 weeks of Cycle 1 Day 1
Receipt of investigational treatment within 3 weeks of scheduled Cycle 1 Day 1 (C1D1) dosing.
Treatment with investigational therapy within 14 days prior to Cycle 1, Day 1
Treatment with any anti-cancer agent 14 days prior to Cycle, Day 1 other than aPD-1 based therapy
The following laboratory results must be met during screening and also immediately before study drug administration on Cycle 1 Day 1:
Prior standard or investigational anti-cancer therapy as specified: Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1; Radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).
Participation in any interventional study within 4 weeks of Cycle 1 Day 1 or 5 half-lives of the investigational agent(s) used in the interventional study prior to Cycle 1 Day 1 (whichever is longer).
Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Cycle 1 Day 1.
Subject must have adequate organ function as defined below. The following parameters must be evaluated within 28 days prior to Cycle 0 Day 1 (monotherapy run-in period):
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Average transfusion requirement of ? 2 units per 28 days of packed RBCs confirmed for a minimum of 112 days immediately preceding Cycle 1 Day 1.
No consecutive 56 days that was RBC transfusion-free during the 112 days immediately preceding Cycle 1 Day 1.
Use of an ESA within the 4 weeks prior to Cycle 1 Day 1.
Have no symptoms of cranial hypertension or convulsions within 14 days before Cycle 1 Day 1 (anti-epileptic drugs and corticoids are allowed to control any preexisting symptoms)
Receipt of anti-cancer therapy 14 days prior to Cycle 1 Day 1
Platelet count >= 100 X 10^9/L within 14 days of starting cycle 1 day 1 treatment
Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
Has persistent phosphate level greater than upper limit of normal (ULN) during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management
Research MRI sequences performed at Massachusetts General Hospital Charlestown Navy Yard must be completed =< 7 days of cycle 1 day 1
Progressive disease on bendamustine within 6 months of cycle 1, day 1
Treatment with systemic steroids for > 4 weeks prior to cycle 1 day 1 of study therapy; prior radiation therapy, with the exception of an abbreviated course (not more than 3 days) if used for superior vena cava (SVC) syndrome
Chemotherapy or targeted therapy within 14 days prior to cycle 1 day 1 of protocol therapy
Current use or history of receiving a non-approved, investigational treatment within 14 days prior to cycle 1 day 1 of protocol therapy
Previous radiotherapy within 7 days of Cycle 1 Day 1.
Treatment with any other investigational agent within 3 weeks prior to cycle 1, day 1
Radio-immunoconjugate within 12 weeks prior to Day 1 of Cycle 1.
Prior treatment of PTCL with systemic anti-lymphoma therapies, investigational agents, radiation; exception: may have received 1 cycle of CHOP-like therapy (e.g. CHOP, CHOEP, EPOCH); these participants must initiate day 1 cycle 1 of CHEP-BV no less than 19 days from prior CHOP-like therapy
Episode of significant cardiovascular/cerebrovascular acute disease within 6 months prior to Cycle 1 Day 1
Malignancies other than UC within 5 years prior to Cycle 1, Day 1
Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
Prior treatment with bicalutamide (Casodex®) or nilutamide (Nilandron®) within 6 weeks of Cycle 1, Day 1
Administration of an investigational therapeutic agent within 28 days of Cycle 1, Day 1
At least 1 week since the last systemic therapy regimen prior to Cycle 1 Day 1. Subjects on a stable dose of hydroxyurea for at least 2 weeks prior to Cycle 1 Day 1 may continue on hydroxyurea until Cycle 1 Day 7. Subjects must have recovered to NCI CTCAE v. 4.03 < Grade 2 from all acute toxicities (excluding Grade 2 toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
Ongoing treatment with an anticancer agent for CMML not contemplated in this protocol. Subjects on a stable dose of hydroxyurea for at least 2 weeks prior to Cycle 1 Day 1 may continue on hydroxyurea until Cycle 1 Day 7.
Cytotoxic therapy within 21 days prior to cycle 1 day (D) 1
The tumor site selected for injection cannot have been irradiated within 8 weeks of Cycle 1 Day 1 (C1D1)
Any systemic anticancer therapy within 3 weeks prior to Cycle 1, Day 1
Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
Patients who have received:\r\n* Radiation or chemotherapy =< 4 weeks\r\n* Mitomycin C, nitrosureas, or radio-immunotherapy =< 6 weeks, or\r\n* Immunotherapy or targeted therapy (such as kinase inhibitors) =< 2 weeks prior to cycle 1 day 1; patients who are on ibrutinib at study entry are not required to discontinue ibrutinib for any period of time\r\n* Palliative steroids for disease related symptoms are allowed as long as dose is tapered down to an equivalent of =< 10 mg of oral prednisone daily on cycle 1 day 1
Chemotherapy within 2 weeks of first dose of sEPHB4-HSA (minimum of 6 weeks for nitrosoureas and 8 weeks for bone marrow transplantation) with the following exceptions:\r\n* Hydroxyurea allowed prior to, and up to day +5 of cycle 0 of treatment (max 100 mg/kg/day)\r\n* Corticosteroids allowed until day -3 (max dexamethasone 20mg/day)\r\n* Maintenance chemotherapy for ALL allowed one week prior to start of treatment (e.g., POMP)
Adequate organ function with the following laboratory results during screening (within 21 days) and immediately before study drug administration on Cycle 1 Day 1:
Be willing to provide peripheral blood samples at screening and day 1 of cycle 2 and cycle 3 for correlative studies
Obtained within 21 days prior to cycle 1, day 1: serum bilirubin =< 1.5 x ULN
Within 28 days of cycle 1 day 1: Platelets >= 75,000/mcL
Patients who have received any other investigational agents within the past 28 days prior to cycle 1 day 1
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
Patients who have not recovered from side effects of prior systemic therapy prior to cycle 1 day 1
Receipt of anti-cancer therapy prior to Cycle 1 Day 1: no chemotherapy, radiation therapy, small molecule tyrosine kinase inhibitor (TKI), or hormonal therapy for the treatment of cancer within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1. No immune therapy or other biologic therapy (other monoclonal antibodies or antibody-drug conjugates [ADCs]) for the treatment of cancer within 28 days of Cycle 1 Day 1.
Prior systemic treatment with an azole drug within four weeks of cycle 1 day 1.
Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiotherapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to day 1 of cycle 1. Patients are permitted to be on dabrafenib and trametinib at start of therapy without wash-out period prior to day 1 of cycle 1. Dosing will change to protocol determined dose levels on day 1 of cycle 1.
Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic, untreated, not stable for >= 4 weeks prior to day 1 of cycle 1 (must be documented by imaging), or requiring corticosteroids to manage metastasis-related symptoms. Subjects who have been off of corticosteroids for at least 2 weeks prior to day 1 of cycle 1 or are on a stable dose of =< 10 mg per day of a prednisone equivalent for > 1 month prior to day 1 of cycle 1 can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks prior to day 1 of cycle 1.
Patients whose disease is refractory (defined as evidence of disease progression while on drug or within 3 months of its discontinuation) to more than 2 lines of chemotherapy given for CRPC. Any number of chemotherapies to which the patient’s disease is not refractory are allowed, as long as time on treatment did not exceed 6 months (counted from day 1 of cycle 1 to day 1 of the last cycle of treatment).
Be taking prednisone at a dose of =< 10 mg/day, 7 days prior to starting treatment (cycle 1 day 1[(C1D1])
Any other on-going chemotherapeutic, biologic, radiopharmaceutical, or investigational agent currently or within 28 days of cycle 1 day 1
Lymphoma that is not amenable for mandatory pre- and cycle 2 day 15 (C2D15) post-treatment biopsy
Adequate haematological and end-organ function, as per the local institutions reference ranges, within 72 hrs prior to day 1 of cycle 1 of treatment defined by the following:
Ability and availability to complete all prescribed biopsies (prior to the first evofosfamide dose and between day 15 of Cycle 2 and day 8 of Cycle 3)
Fewer than 28 days before Cycle 1 Day 1 since any prior chemotherapy (less than 42 days in the case of mitomycin or a nitrosourea)
Fewer than 28 days before Cycle 1 Day 1 since administration of hormonal or biological anti-neoplastic agents
Participation in another investigational drug trial concurrently or within 30 days of Cycle 1 Day 1, or a vaccine trial within 90 days of Cycle 1 Day 1
Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
Only participants whose lymphoma is untreated are allowed for the dose-finding portion; for the dose expansion cohort both untreated and participants who have received a maximum of one cycle of combination chemotherapy, including rituximab-containing regimens R-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone (CHOP) and R-EPOCH, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior and 28 days maximum to beginning treatment under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e. cycle off study will count as cycle 1)
Prior systemic anti-myeloma therapy within 14 days of Cycle 1 Day 1
Immunosuppressive therapy within 6 weeks of Cycle 1 Day 1
Daily corticosteroid requirement within 2 weeks of Cycle 1 Day 1
The following patients are allowed:\r\n* Patients may have been treated for AML or antecedent hematologic disorder with myeloid growth factors, recombinant erythropoietin, thalidomide, lenalidomide, 5-azacitidine or decitabine\r\n* Any prior chemo therapy must have been completed >= 2 weeks prior to day 1 of study treatment and the participant must have recovered to eligibility levels from prior toxicity\r\n* There is no limit for prior chemo regimens\r\n* Patients may have received hematopoietic stem cell transplantation for AML or other diseases\r\n* Hydroxyurea is allowed prior to day 1 of study treatment for count control and during cycle 1; the use of hydroxyurea is not allowed beyond completion of cycle 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Neutrophil count >= 1.5 x 10^9/l at cycle 1 day 1 of docetaxel cisplatin and 5-FU (TPF)
Platelet count >= 100 x 10^9/l at cycle 1 day 1 of TPF
Hemoglobin >= 10 g/dl at cycle 1 day 1 of TPF
Platelets >= 100,000/mcL, during screening and on cycle 1, day 1
Has an active infection requiring systemic therapy which is not expected to have resolved by cycle 1 day 1 dosing
Patients who have had an active infection requiring systemic therapy =< 7 days prior to day -14 are not eligible UNLESS they are symptom-free and have a negative culture at the time of dosing on day -14
Treatment within 12 months of cycle 1 day 1 with any Cyp17-lyase inhibitor, any 2nd generation AR antagonist (e.g. enzalutamide), cabazitaxel or carboplatin
Patients whose disease is refractory (defined as evidence of disease progression while on drug or within 3 months of its discontinuation) to more than 2 lines of chemotherapy; any number of chemotherapies to which the patient’s disease is not refractory are allowed, as long as time on treatment did not exceed 6 months (counted from day 1 of cycle 1 to day 1 of the last cycle of treatment)
Flutamide (Eulexin) treatment within 4 weeks of cycle 1, day 1 and bicalutamide (Casodex) or nilutamide (Nilandron) within 6 weeks of cycle 1 day 1 (exceptions: if progression is documented prior to this time interval, or if patient is deemed by the treating physician to be highly unlikely to respond to AR inhibitor withdrawal (e.g. if PSA did not decline for 3 months in response to AR inhibitor given as a second line or later intervention, or if patient has symptoms attributable to disease progression) only a 3 day washout prior to cycle 1, day 1 will be required for any of them
Current or recent (within 10 calendar days prior to cycle 1, day 1) use of dipyridamole, ticlopidine, clopidogrel, or cilostazol
Treatment with an investigational therapeutic within 30 days of cycle 1
Availability of a frozen biopsy core prior to cycle 1, day 1
Administration of an investigational therapeutic within 30 days of cycle 1, day -2
Chemotherapy or hormonal therapy for anti-cancer treatment within 28 days prior to Cycle 1 Day 1.
Immunotherapy or biological therapy (e.g., monoclonal antibodies) within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
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.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle 1 Day 1 is not permitted.
Subjects screened between 1 to 12 weeks after last cycle of chemotherapy
Patients must be beyond day 30 and before day 75 after transplant
Chemotherapy or immunotherapy or any other anticancer therapy =< 3 weeks prior to cycle 1 day 1; hydroxyurea may be continued until 72 hours prior to first dose and at least 24 hours before the baseline bone marrow aspiration is performed
Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to day 1 of cycle 1; patients are permitted to be on dabrafenib and trametinib standard of care at start of therapy without wash-out period prior to day 1 of cycle 1; dosing will change to protocol determined dose levels on day 1 of cycle 1
Prior systemic treatment with an azole anti-fungal drug (e.g. fluconazole, itraconazole) within 4 weeks of cycle 1, day 1
Administration of an investigational therapeutic within 30 days prior to cycle 1, day 1
Patients must be willing to use the Optune device >= 18 hours/day for at least 23 days in a 28-day cycle, and keep head shaved throughout treatment
Histologically confirmed solid tumor malignancy for which platinum-based chemotherapy on a 21-day cycle or 14 day cycle is being recommended
Chemotherapy within 3 weeks of Cycle 1 Day 1
Severe infection within 4 weeks prior to Day 1 of Cycle 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1 (localized radiation to a single site at least 1 week before cycle 1 day 1 is permissible)
Minimum intervals required to be off treatment prior to Cycle 1 Day 1:
Cancer-related exclusion criteria:\r\n* Patients with known MSI-high status or unknown MSI status are not eligible for study entry\r\n* Patients with BRAF V600E mutations are not eligible for the study\r\n* Surgical procedure (surgical resection, wound revision or any other major surgery) or significant traumatic injury within 60 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study. Minor surgical procedure within 7 days (including placement of a vascular access device) of study cycle 1 day 1\r\n** Study-related biopsies are NOT considered surgical procedures under the exclusion criteria\r\n* Untreated central nervous system (CNS) metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to initiation of study treatment\r\n* Treatment with any investigational agent or approved therapy within 21 days (cycle 1 day 1)\r\n* Malignancies other than CRC within 3 years prior to cycle 1 day 1 with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)\r\n* Prior radiation therapy within 14 days prior to study cycle 1 day 1 and/or persistence of radiation-related adverse effects. However, palliative radiation therapy (as long as it does not involve target lesions) is permitted on the study\r\n* Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past\r\n* Spinal cord compression not definitively treated with surgery and/or radiation\r\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\r\n* Uncontrolled tumor related pain. Patients who require narcotic pain medication during screening should be on a stable dose regimen prior to cycle 1 day 1
Exclusion criteria based on organ function or medical history:\r\n* History of clinically significant cardiac or pulmonary dysfunction including the following:\r\n** Inadequately controlled hypertension (that is defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg that is treated or untreated)\r\n** History of myocardial infarction within 6 months prior to first dose of study drug in cycle\r\n** Prior history of hypertensive crisis or hypertensive encephalopathy\r\n** History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or non-infectious pneuomonitis requiring steroids\r\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of cycle 1 day 1\r\n* History of stroke or transient ischemic attack within 6 months prior to cycle 1 day 1\r\n* Serious non-healing wound, active ulcer or untreated bone fracture\r\n* History of abdominal fistula or gastrointestinal perforation within 6 months prior to cycle 1 day 1\r\n* History of hemoptysis (?one teaspoon of bright red blood per episode), or any other serious hemorrhage or at risk of bleeding (gastrointestinal history of bleeds, gastrointestinal ulcers, etc.). INR > 1.5 and aPTT > 1.5 x ULN within 7 days prior to cycle 1 day 1. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding\r\n* Life expectancy of < 12 weeks\r\n* Any previous venous thromboembolism >= grade 3\r\n* Proteinuria at screening as demonstrated by urine dipstick >= 2+ or 24-hour. proteinuria > 1.0 g\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal\r\n* Uncontrolled serious medical or psychiatric illness\r\n* Pregnant or lactating, or intending to become pregnant during the study. Women who are not post-menopausal (>= 12 continuous months of amenorrhea with no identified cause other than menopause) or surgically sterile must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1
Patients must have cHL that has not been previously treated (patients who have received one dose [day 1 cycle 1] of standard doxorubicin hydrochloride [adriamycin], bleomycin, vinblastine and dacarbazine [ABVD] or doxorubicin hydrochloride, vinblastine, dacarbazine [AVD] may be enrolled as long as they completed all the required standard of care baseline studies before enrollment and initiate study therapy by day 15 cycle 1)
At cycle 1 day 1 pre-dosing: Creatinine > 2 x ULN
Surgery or local prostatic intervention (excluding a prostatic biopsy) less than 28 days of Cycle 1 Day 1.
Pediatric patients ? 1 day old on Cycle 1 Day 1 (C1D1)
Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
Maintenance should commence within 60 days of recovery of peripheral blood counts after consolidation cycle 2; patients must begin consolidation cycle 2 within 60 days of recovery to be eligible for further therapy
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
Willingness to provide the biologic specimens is required by the protocol; this is part of the mandatory correlative research component; these specimens include:\r\n- PHASE I: peripheral blood for plasma pharmacokinetic analysis and peripheral blood mononuclear cell (PBMC) polymer assessment from 0-24 h after drug administration on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; urine for assessment of ABT-888 renal clearance for 24 h after administration of drugs on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; and a pretreatment peripheral blood sample for possible sequencing of the BRCA1, BRCA2 loci as well as possible pharmacogenomic analysis
Participants who have undergone a major surgical procedure or trauma within 4 weeks prior to cycle 1, day 1; all wounds must be fully healed on cycle 1, day 1
Patients who have had chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to cycle 1 day 1; patients who have had tyrosine kinase inhibitors (such as Braf or MEK inhibitors) within 15 days of cycle 1 day 1
Radiation, chemotherapy, or immunotherapy or any other approved anticancer therapy =< 2 weeks prior to cycle 1 day 1
Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1 or radio-immunotherapy =< 4 weeks prior to cycle 1 day 1
Participants who are untreated or who received a maximum of one (1) cycle of combination chemotherapy, including rituximab-containing regimens, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior to beginning treatment under this protocol, and such cycle will count towards the total maximum of 6 cycles under this study
Has had minor surgery (i.e., simple excision, tooth extraction) <7 days prior to the first dose of study drug (Cycle 1, Day 1).
Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy
Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day 1;
Agree to provide core biopsies at baseline and at Cycle 2 Day 15
Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria
Radiation therapy within 2 weeks prior to Cycle 1, Day 1
Patients who have, within 14 days prior to Day 1 dosing:
Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
A bone marrow biopsy must be performed within four weeks prior to Cycle 1 Day 1 treatment to establish the baseline fibrosis score;
Patients must have been off of chemotherapy for at least 4 weeks prior to day 1 of cycle 1; informed consent can be signed at any time prior to the start of therapy
Significant cardiac event within 12 months before Cycle 1 Day 1.
Current or recent (within 10 calendar days prior to cycle 1, day 1) use of dipyramidole, ticlopidine, clopidogrel, or cilostazol
For participants with relapsed or refractory FL: prior allogeneic or autologous stem cell transplantation, anthracycline therapy, treatment with fludarabine or alemtuzumab within 12 months prior to Day 1 of Cycle 1, treatment with a monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1, radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Participant has received anti-myeloma treatment within 2 weeks before Cycle 1 Day 1
Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
Deteriorating neurological symptoms, or need for increasing doses of corticosteroids or new onset of seizures between the screening assessment and cycle 1 day 1
Any approved anti-cancer therapy within 3 weeks prior to enrollment with the following exceptions: \r\n* Palliative radiotherapy for bone metastases must be completed > 7 days prior to baseline imaging and > 21 days prior to cycle 1 day 1 of treatment\r\n* Hormone replacement therapy or oral contraceptives are permitted \r\n* Administration of intravesical bacillus Calmette-Guerin (BCG) > 4 weeks before cycle 1, day 1 is allowed
Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after.
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 3 weeks prior to cycle 1 day 1; treatment with mitomycin C or radio-immunotherapy must be completed within 6 weeks prior to cycle 1 day 1
Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1
Chemotherapy (approved or investigational) within 3 weeks prior to the first day of treatment or antibody therapy within 6 weeks prior to the first day of treatment
Received crizotinib within 3 days of the first dose of brigatinib (Day 1, Cycle 1).
Thromboembolism within 6 months of cycle 1, day 1
Strontium-89, samarium-153, or radium-223 therapy within 4 weeks of cycle 1, day 1
No treatment with cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1
No treatment with a steroid intended to treat myeloma within 14 days prior to cycle 1 day 1
Radiation therapy for treatment of the primary tumor within 6 weeks of cycle 1, day 1
Radiation or radionuclide therapy for treatment of metastatic CRPC tumor within 2 or 6 weeks, respectively, of cycle 1, day 1
Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of cycle 1, day 1
Prior flutamide (Eulexin) treatment within 4 weeks of cycle 1, day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to cycle 1, day 1)
Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of cycle 1 day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to cycle 1, day 1)
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Subjects must have platelet count greater than 25,000 per microliter at baseline and at the start of study (day 1, cycle 1) visit
Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of cycle 1, day 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Administration of an investigational therapeutic drug within 30 Days of Cycle 1 Day 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Radiotherapy or systemic therapy within 2 weeks of Cycle 1 Day 1 (C1D1)
Cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Peripheral white blood cell (WBC) count 30,000/µL For cyto-reduction, hydroxyurea is allowed during screening and up to Cycle 1, Days 1-14, to reduce WBC count to < 30,000 µL prior to Day 1. After Cycle 1, Day 14, hydroxyurea is prohibited.
In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
Prior treatment with dose dense regimens of temozolomide is not allowed (e.g, 7 days on/7 days off, 21 day/28 day and daily low dose continuous dosing). However, prior treatment with standard day 1-5 dosing in the adjuvant setting and low dose daily dosing as part of chemoradiation therapy are allowed
At least 4 weeks must elapse between the completion of the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy or experimental therapy and administration of the first vaccine; completion is defined as last day of any treatment/therapy, not last day of last cycle
Use of systemic corticosteroids ? 2 weeks before Cycle 1 Day 1.
Received the last dose of previous treatment / therapy before Day 1 of cycle 1:
Subject has the following blood chemistry levels at screening (obtained ? 14 days prior to starting Cycle 1 Day 1):
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ? 2 weeks prior to Cycle 1 Day 1, except ibrutinib which may be continued until one day prior to initiation of selinexor; radio-immunotherapy 4 weeks prior to Cycle 1 Day 1. Patients must have recovered to Grade ? 1 from clinically significant adverse effects.
At least 21 days must have elapsed prior to Day 1 Cycle 1, since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 since \limited palliative radiotherapy\, defined as a course of therapy encompassing <25% total bone marrow volume and not exceeding 30 GY.
Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1
Any malignancy within 5 years prior to Cycle 1, Day 1
Prior systemic treatment with an azole drug (fluconazole, itraconazole) within 4 weeks of cycle 1 day 1.
Anti-cancer therapy within the period immediately before Cycle 1 Day 1
Malignancies other than UC within 5 years prior to Cycle 1, Day 1
Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/day for more than 1 day out of 7 days
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1; any clinical trial therapy (including investigational anti-cancer study) =< 3 weeks prior to cycle 1 day 1
Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1 of Cycle 1
Systemic cytotoxic therapies or radiotherapy ?14 days prior to day 1 cycle 1
For two weeks prior to day 1 cycle 1, administration of specified cytochrome P450 3A (CYP3A) inducers
Patients who have been treated with an investigational agent <21 days prior to day 1 of cycle 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for \limited palliative radiotherapy\, defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
Adequate bone marrow, liver, and renal function within the 14 days prior to Day 1 of Cycle 1 of study drug up until pre-dose of Cycle 1
Participants with persistent phosphate greater than upper limit of normal during screening (within 14 days prior to Day 1 of Cycle 1 up until pre-dose of Cycle 1) and despite medical management of phosphate levels
Neutrophil count < 1.5 × 10^9/liter (L) prior to dosing on Cycle 1 Day 1
Platelet count ? 150 × 10^9/L prior to dosing on Cycle 1 Day 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ?3 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1;
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ?2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1.
Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
?2 weeks for cytotoxic therapy (except hydroxyurea, which is permitted at doses of ?5g/day during the first 2 weeks of Cycle 1) prior to C1D1.
Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1
Participation in an investigational anti-cancer study =< 3 weeks prior to cycle day 1
CYCLE II PORTION ONLY: Only participants with a nausea score >= 3 at least once on the diary assessment from cycle 1 can be randomized for cycle 2
CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1
CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1
CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1
Planned administration of an investigational study drug or agent that either can interact with pamidronate or have an independent effect on bone mineral density within the 4 weeks prior to randomization (day 90) or planned use during study participation (day 90 through day 360)
7th or later cycle of intravenous carboplatin or oxaliplatin infusion planned or 4 months after the first cycle of agent (whichever is of longer duration) =< 30 days after registration
Study participation will occur during the first cycle of 5 day temozolomide course
History of intra-abdominal inflammatory process within 6 months prior to Day 1 of Cycle 1
Treatment with any HCV anti-viral therapy within 4 weeks prior to Cycle 1 Day 1
Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
Describe fatigue as being present every day for most of day for a minimum of 2 weeks
Describe fatigue as being present every day for most of the day for a minimum of 2 weeks
If currently menstruating, must know the date of the first day of their latest menstrual cycle
Inclusion Criteria:\n\n        Cycle 1:\n\n        The following inclusion criteria must be checked prior to inclusion at Cycle 1:\n\n          1. Patient read, understood and signed the written informed consent before any study\n             related activity, agreeing to participate in the study and to comply with study\n             requirements.\n\n          2. Female patient of at least 8 years of age.\n\n          3. Histologically or cytologically confirmed breast cancer, including recurrent or\n             metastatic.\n\n          4. Naïve to moderately or highly emetogenic antineoplastic agents.\n\n          5. Scheduled to receive at least 4 consecutive cycles of an AC combination regimen.\n\n             Notes:\n\n               1. additional not emetogenic, minimally or low emetogenic antineoplastic agents are\n                  permitted at any time after start of AC combination on Day 1.\n\n               2. additional highly or moderately emetogenic antineoplastic agents are only allowed\n                  on Day 1 after the start of AC combination, provided their administration is\n                  completed within 6 hours from the start of the AC combination administration.\n\n          6. ECOG Performance Status of 0 or 1.\n\n          7. Patient shall be: a) of non-childbearing potential or b) of childbearing potential\n             using reliable contraceptive measures and having a negative urine pregnancy test\n             within 24 hours prior to dose of investigational product.\n\n             Notes:\n\n               1. Female patients of non-childberaring potential are defined as being in\n                  post-menopausal state since at least 1 year; or having documented surgical\n                  sterilization or hysterectomy at least 3 months before study participation.\n\n               2. Reliable contraceptive measures include implants, injectables, combined oral\n                  contraceptives, intrauterine devices, vasectomized partner or complete (long\n                  term) sexual abstinence;\n\n          8. Hematologic and metabolic status adequate for receiving a cycle of AC chemotherapy\n             based on investigator's assessment.\n\n          9. If the patient has a known hepatic or renal impairment, she may be enrolled in the\n             study at the discretion of the Investigator.\n\n         10. Able to read, understand, follow the study procedure and complete the patient diary.\n\n        All inclusion criteria will be checked at screening visit (Visit 1 of Cycle 1); inclusion\n        criteria 7 will be re-checked at Day 1 (Visit 2).\n\n        Cycles 2 to 4:\n\n        The following inclusion criteria must be checked prior to inclusion at each repeated cycle:\n\n          1. Participation in the study during the next cycle of chemotherapy is considered\n             appropriate by the Investigator and does not pose unwarranted risk to the patient.\n\n          2. Scheduled to receive an AC chemotherapy regimen or AC chemotherapy together with other\n             chemotherapies as defined in Inclusion criterion #5 for Cycle 1.\n\n          3. Patient shall be: a) of non-childbearing potential or b) of childbearing potential\n             using reliable contraceptive measures and having a negative urine pregnancy test\n             within 24 hours prior to dosing of investigational product.\n\n          4. Adequate hematologic and metabolic status for receiving a cycle of AC chemotherapy\n             according to the Investigator's opinion.\n\n        All inclusion criteria will be checked at screening visit (Visit 1); inclusion criterion #3\n        will be re-checked at Day 1 (Visit 2).\n\n        Exclusion Criteria:\n\n        Cycle 1:\n\n        The following exclusion criteria must be checked prior to inclusion at Cycle 1:\n\n          1. Lactating patient.\n\n          2. Current use of illicit drugs or current evidence of alcohol abuse.\n\n          3. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition\n             to the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 and up\n             to Day 1 of Cycle 2.\n\n          4. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis\n             within 1 week prior to the start of AC chemotherapy administration on Day 1 or between\n             Days 1 to 5, inclusive.\n\n          5. Any vomiting, retching, or nausea (grade 1 as defined by National Cancer Institute)\n             within 24 hours prior to the start of AC chemotherapy administration on Day 1.\n\n          6. Symptomatic primary or metastatic central nervous system (CNS) malignancy.\n\n          7. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial\n             pressure, hypercalcemia, an active infection or any illness or medical conditions\n             (other than malignancy) that, in the opinion of the Investigator, may confound the\n             results of the study, represent another potential etiology for emesis and nausea\n             (other than chemotherapy-induced nausea and vomiting [CINV]) or pose unwarranted risks\n             in administering the study drugs to the patient.\n\n          8. Known hypersensitivity or contraindication to 5 hydroxytryptamine type 3 (5-HT3)\n             receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron,\n             tropisetron, ramosetron), to dexamethasone, or to neurokinin-1 (NK1) receptor\n             antagonists (e.g., aprepitant, rolapitant).\n\n          9. Known contraindication to the IV administration of 50 mL 5% glucose solution.\n\n         10. Participation in a previous clinical trial involving IV fosnetupitant or oral\n             netupitant administered alone or in combination with palonosetron.\n\n         11. Any investigational drugs taken within 4 weeks prior to Day 1, and/or is scheduled to\n             receive any investigational drug (other than those planned by the study protocol)\n             during the present study.\n\n         12. Systemic corticosteroid therapy within 72 hours prior to the start of AC chemotherapy\n             administration on Day 1, except the dexamethasone provided as additional study drug.\n             However, topical and inhaled corticosteroids are permitted.\n\n         13. Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy\n             during the study participation.\n\n         14. Other than as administered as part of the study protocol, any medication with known or\n             potential antiemetic activity within 24 hours prior to the start of AC chemotherapy\n             administration on Day 1, including:\n\n               -  5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron,\n                  tropisetron, ramosetron, palonosetron)\n\n               -  NK1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant or any\n                  other new drug of this class)\n\n               -  benzamides (e.g., metoclopramide, alizapride)\n\n               -  phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine,\n                  thiethylperazine, chlorpromazine)\n\n               -  benzodiazepines (except if the subject is receiving such medication for sleep or\n                  anxiety and has been on a stable dose for at least seven days prior to Day 1).\n\n               -  butyrophenones (e.g., haloperidol, droperidol)\n\n               -  anticholinergics (e.g., scopolamine, with the exception of inhaled\n                  anticholinergics for respiratory disorders, e.g., ipratropium bromide)\n\n               -  antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine, chlorpheniramine)\n\n               -  domperidone\n\n               -  mirtazapine\n\n               -  olanzapine\n\n               -  prescribed cannabinoids (e.g., tetrahydrocannabinol or nabilone)\n\n               -  Over The Counter (OTC) antiemetics, OTC cold or OTC allergy medications.\n\n         15. Scheduled to receive any strong or moderate inhibitor of CYP3A4 during the efficacy\n             assessment period (Day 1 to Day 5, inclusive) or its intake within 1 week prior to Day\n             1.\n\n         16. Scheduled to receive any CYP3A4 inducer during the efficacy assessment period (Day 1\n             to Day 5, inclusive) or its intake within 4 weeks prior to Day 1, with the exception\n             of corticosteroids (for which exclusion criterion #12 applies).\n\n         17. History or predisposition to cardiac conduction abnormalities, except for incomplete\n             right bundle branch block.\n\n         18. History of risk factors for Torsades de Pointes (heart failure, hypokalemia, family\n             history of Long QT Syndrome).\n\n         19. Severe or uncontrolled cardiovascular diseases, including myocardial infarction within\n             3 months prior to Day 1, unstable angina pectoris, significant valvular or pericardial\n             disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure\n             (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial\n             hypertension.\n\n        All exclusion criteria with the exception of criteria #5, #12, and #14 will be checked at\n        screening visit (Visit 1). Exclusion criteria #5, #12, and #14 will be checked at Day 1\n        (Visit 2) only.\n\n        Exclusion criteria #3, #4, #7, #11, #13, #15, and #16 need to be re-checked at Day 1 (Visit\n        2).\n\n        Cycles 2 to 4:\n\n        The following exclusion criteria must be checked prior to inclusion at each repeated cycle:\n\n          1. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition\n             to the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 of\n             current cycle and up to Day 1 of the next cycle.\n\n          2. Active infection or uncontrolled disease that may pose unwarranted risks in\n             administering the study drugs to the patient.\n\n          3. Started any of the prohibited medications.\n\n          4. Any vomiting, retching, or nausea (grade ? 1 as defined by National Cancer Institute)\n             within 24 hours prior to the start of AC chemotherapy administration on Day 1.\n\n          5. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis\n             within 1 week prior to the start of AC chemotherapy administration on Day 1 or between\n             Days 1 to 5.\n\n          6. Symptomatic primary or metastatic CNS malignancy.\n\n          7. Any illness or medical condition that, in the opinion of the investigator, may\n             confound the results of the study or pose unwarranted risks in administering the\n             investigational product or dexamethasone to the patient.\n\n        All exclusion criteria, with exception of criterion #4, will be checked at screening visit\n        (Visit 1). Exclusion criterion #4 will be checked at Day 1 (Visit 2) only. Exclusion\n        criteria #2, #3 and #5 need to be re-checked at Day 1 (Visit 2).
Women who are using postmenopausal hormones, and are planning to continue the same regimen through surgery are eligible to participate; if the hormone therapy regimen is cyclical, the following should be recorded regarding the day of baseline core biopsy and day of surgery: the agent, the day of the phase (e.g. day 13 of 14-day estrogen phase etc); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
?100% increase in WBC count (myeloid cell line and monocyte series) within the 8-week period leading to Cycle 1, Day 1
Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study day 1 or treatment with a therapeutic antibody less than 4 weeks prior to study day 1 as well as systemic radiation therapy within 28 days prior to study day 1 or focal radiotherapy within 14 days prior to study day 1.
Patient must start everolimus 10mg plus exemestane 25mg treatment on Cycle 1 Day 1 of trial
Washout period prior to Day 1 Cycle 1:
Patients must have had treatment with temozolomide, lomustine (CCNU) or PCV (procarbazine, lomustine [CCNU], vincristine) chemotherapy prior to histopathologic transformation to glioblastoma or prior to identification of one of the genetic alterations specified; notes or records from the treating oncologist are required for documentation of treatment history; prior treatment with at least one of the following chemotherapy schedules is required to be eligible:\r\n* At least one 6 week course of continuous daily temozolomide\r\n* At least six 28-day cycles given in one of the following schedules:\r\n** Daily for 5 days of a 28-day cycle\r\n** Daily for 21 days of a 28-day cycle\r\n** Daily for 14 days of a 28-day cycle\r\n** Alternating 7 days on/7 days per 28-day cycle\r\n** Continuous daily dosing of a 28-day cycle\r\n* Other schedules of temozolomide may be considered after discussion with the overall principal investigator\r\n* At least 3 cycles of PCV or lomustine (CCNU) chemotherapy