Malignancies other than RCC within  years prior to Cycle , Day 
Patients may have received one and only one cycle of chemotherapy prior to enrolling on Cancer and Leukemia Group B (CALGB) , 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  must take place within - days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB 
Patients must not have unequivocal disease progression (by RECIST v.) during the first cycle; patients must have disease assessed using the same method as baseline within +/-  days of the day  scheduled assessment (between days - of cycle , or days - of cycle ); all disease must be assessed and documented on the follow-up tumor assessment form (RECIST .)
Phase  ONLY: Subject has had any prior anti-cancer therapy other than: Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ?  weeks prior to Cycle  Day -). One line of cytotoxic chemotherapy (must be completed ?  weeks prior to Cycle  Day -). Adjuvant/neoadjuvant radiotherapy (must be completed ?  months prior to Cycle  Day -, with field not involving > % of bone marrow reserve).
Phase  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 ?  weeks prior Cycle  Day -.
Previous treatment with radiotherapy or immunotherapeutic agents in the  weeks prior to study drug administration (Cycle  Day )
Use of immunosuppressant medications in the  weeks prior to study drug administration (Cycle  Day )
Demonstrated adequate organ function within  days of Cycle  Day  (CD).
Antithymocyte globulin or similar anti-T cell antibody therapy ?  weeks prior to Cycle  Day 
Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor (CAR) T cells directed against B cells within  weeks of Cycle  Day 
Receipt of investigational treatment within  weeks of scheduled Cycle  Day  (CD) dosing.
Treatment with any anti-cancer agent  days prior to Cycle, Day  other than aPD- based therapy
The following laboratory results must be met during screening and also immediately before study drug administration on Cycle  Day :
Prior standard or investigational anti-cancer therapy as specified: Radioimmunoconjugate within  weeks prior to Day  of Cycle ; Monoclonal antibody or antibody-drug conjugate within  weeks prior to Day  of Cycle ; Radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within  weeks prior to Day  of Cycle 
Patients receiving cancer therapy within  weeks prior to Cycle Day (CD).
Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least  weeks prior to Cycle  Day ). Controlled brain metastases that require continuous high dose corticosteroid use within  weeks of Cycle  Day .
Subject must have adequate organ function as defined below. The following parameters must be evaluated within  days prior to Cycle  Day  (monotherapy run-in period):
Malignancies other than disease under study within  years prior to Day  of Cycle 
Average transfusion requirement of ?  units per  days of packed RBCs confirmed for a minimum of  days immediately preceding Cycle  Day .
Use of an ESA within the  weeks prior to Cycle  Day .
Receipt of anti-cancer therapy  days prior to Cycle  Day 
Platelet count >=  X ^/L within  days of starting cycle  day  treatment
Non-tolerable > Grade  neuropathy or evidence of unstable neurological symptoms within  weeks of Cycle  Day .
Autologous or allogenic transplant within the  days prior to Cycle  Day .
Has persistent phosphate level greater than upper limit of normal (ULN) during screening (within  days of treatment and prior to Cycle  Day ) and despite medical management
Research MRI sequences performed at Massachusetts General Hospital Charlestown Navy Yard must be completed =<  days of cycle  day 
Progressive disease on bendamustine within  months of cycle , day 
Treatment with systemic steroids for >  weeks prior to cycle  day  of study therapy; prior radiation therapy, with the exception of an abbreviated course (not more than  days) if used for superior vena cava (SVC) syndrome
Chemotherapy or targeted therapy within  days prior to cycle  day  of protocol therapy
Previous radiotherapy within  days of Cycle  Day .
Completion of ASCT within  days prior to Day  of Cycle.
Radio-immunoconjugate within  weeks prior to Day  of Cycle .
Prior treatment of PTCL with systemic anti-lymphoma therapies, investigational agents, radiation; exception: may have received  cycle of CHOP-like therapy (e.g. CHOP, CHOEP, EPOCH); these participants must initiate day  cycle  of CHEP-BV no less than  days from prior CHOP-like therapy
Episode of significant cardiovascular/cerebrovascular acute disease within  months prior to Cycle  Day 
Malignancies other than UC within  years prior to Cycle , Day 
Severe infections within  weeks prior to Cycle , Day 
Failed prior alloSCT within the past  months from Cycle  Day 
Prior treatment with bicalutamide (Casodex) or nilutamide (Nilandron) within  weeks of Cycle , Day 
Prior treatment with -alpha reductase inhibitors within  weeks of Cycle , Day 
At least  week since the last systemic therapy regimen prior to Cycle  Day . Subjects on a stable dose of hydroxyurea for at least  weeks prior to Cycle  Day  may continue on hydroxyurea until Cycle  Day . Subjects must have recovered to NCI CTCAE v. . < Grade  from all acute toxicities (excluding Grade  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  weeks prior to Cycle  Day  may continue on hydroxyurea until Cycle  Day .
Cytotoxic therapy within  days prior to cycle  day (D) 
The tumor site selected for injection cannot have been irradiated within  weeks of Cycle  Day  (CD)
Any radiation treatment to metastatic site within  days of Cycle , Day 
Be willing to provide peripheral blood samples at screening and day  of cycle  and cycle  for correlative studies
Obtained within  days prior to cycle , day : serum bilirubin =< . x ULN
Within  days of cycle  day : Platelets >= ,/mcL
Prior to dosing with urine sample obtained on Cycle  Day , if it has been >  days since obtaining the serum pregnancy test results.
Patients who have not recovered from side effects of prior systemic therapy prior to cycle  day 
Receipt of anti-cancer therapy prior to Cycle  Day : no chemotherapy, radiation therapy, small molecule tyrosine kinase inhibitor (TKI), or hormonal therapy for the treatment of cancer within  days or  half-lives (whichever is shorter) of Cycle  Day . No immune therapy or other biologic therapy (other monoclonal antibodies or antibody-drug conjugates [ADCs]) for the treatment of cancer within  days of Cycle  Day .
Administration of intravesical BCG within  weeks before cycle , day 
Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiotherapy, immunotherapy, biologic therapy, or vaccine therapy) within the last  weeks prior to day  of cycle . Patients are permitted to be on dabrafenib and trametinib at start of therapy without wash-out period prior to day  of cycle . Dosing will change to protocol determined dose levels on day  of cycle .
Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic, untreated, not stable for >=  weeks prior to day  of cycle  (must be documented by imaging), or requiring corticosteroids to manage metastasis-related symptoms. Subjects who have been off of corticosteroids for at least  weeks prior to day  of cycle  or are on a stable dose of =<  mg per day of a prednisone equivalent for >  month prior to day  of cycle  can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for >  weeks prior to day  of cycle .
Patients whose disease is refractory (defined as evidence of disease progression while on drug or within  months of its discontinuation) to more than  lines of chemotherapy given for CRPC. Any number of chemotherapies to which the patients disease is not refractory are allowed, as long as time on treatment did not exceed  months (counted from day  of cycle  to day  of the last cycle of treatment).
Be taking prednisone at a dose of =<  mg/day,  days prior to starting treatment (cycle  day [(CD])
Lymphoma that is not amenable for mandatory pre- and cycle  day  (CD) post-treatment biopsy
Minor surgical procedure within  calendar days prior to cycle  day 
Adequate haematological and end-organ function, as per the local institutions reference ranges, within  hrs prior to day  of cycle  of treatment defined by the following:
Ability and availability to complete all prescribed biopsies (prior to the first evofosfamide dose and between day  of Cycle  and day  of Cycle )
Fewer than  days before Cycle  Day  since any prior chemotherapy (less than  days in the case of mitomycin or a nitrosourea)
Participation in another investigational drug trial concurrently or within  days of Cycle  Day , or a vaccine trial within  days of Cycle  Day 
Prior to dosing with urine sample obtained on Cycle  Day , if it has been >  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  days prior and  days maximum to beginning treatment under this protocol, and such cycle will count towards the maximum of  cycles under this study (i.e. cycle off study will count as cycle )
Last cycle of most recent salvage therapy within  weeks of enrollment
Prior systemic anti-myeloma therapy within  days of Cycle  Day 
Immunosuppressive therapy within  weeks of Cycle  Day 
Daily corticosteroid requirement within  weeks of Cycle  Day 
Neutrophil count >= . x ^/l at cycle  day  of docetaxel cisplatin and -FU (TPF)
Platelet count >=  x ^/l at cycle  day  of TPF
Platelets >= ,/mcL, during screening and on cycle , day 
Has an active infection requiring systemic therapy which is not expected to have resolved by cycle  day  dosing
Patients whose disease is refractory (defined as evidence of disease progression while on drug or within  months of its discontinuation) to more than  lines of chemotherapy; any number of chemotherapies to which the patients disease is not refractory are allowed, as long as time on treatment did not exceed  months (counted from day  of cycle  to day  of the last cycle of treatment)
Flutamide (Eulexin) treatment within  weeks of cycle , day  and bicalutamide (Casodex) or nilutamide (Nilandron) within  weeks of cycle  day  (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  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  day washout prior to cycle , day  will be required for any of them
Consents to whole blood collection prior to initiating therapy, on cycle  day , and at cystectomy for support of correlative research studies
Current or recent (within  calendar days prior to cycle , day ) use of dipyridamole, ticlopidine, clopidogrel, or cilostazol
Availability of a frozen biopsy core prior to cycle , day 
Chemotherapy or hormonal therapy for anti-cancer treatment within  days prior to Cycle  Day .
Immunotherapy or biological therapy (e.g., monoclonal antibodies) within  days prior to Cycle  Day , unless pre-approval is obtained from the Sponsor Medical Monitor.
Cytotoxic chemotherapy or non-hormonal targeted therapy within  days of Cycle  Day  is not permitted.
Subjects screened between  to  weeks after last cycle of chemotherapy
Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last  weeks prior to day  of cycle ; patients are permitted to be on dabrafenib and trametinib standard of care at start of therapy without wash-out period prior to day  of cycle ; dosing will change to protocol determined dose levels on day  of cycle 
Patients must be willing to use the Optune device >=  hours/day for at least  days in a -day cycle, and keep head shaved throughout treatment
Histologically confirmed solid tumor malignancy for which platinum-based chemotherapy on a -day cycle or  day cycle is being recommended
Chemotherapy within  weeks of Cycle  Day 
Severe infection within  weeks prior to Day  of Cycle 
Minimum intervals required to be off treatment prior to Cycle  Day :
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 VE 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  days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study. Minor surgical procedure within  days (including placement of a vascular access device) of study cycle  day \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  weeks prior to initiation of study treatment\r\n* Treatment with any investigational agent or approved therapy within  days (cycle  day )\r\n* Malignancies other than CRC within  years prior to cycle  day  with the exception of those with a negligible risk of metastasis or death (e.g., expected -year overall survival > %) 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  days prior to study cycle  day  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  day 
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 >  mmHg and/or diastolic blood pressure >  mmHg that is treated or untreated)\r\n** History of myocardial infarction within  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  months of cycle  day \r\n* History of stroke or transient ischemic attack within  months prior to cycle  day \r\n* Serious non-healing wound, active ulcer or untreated bone fracture\r\n* History of abdominal fistula or gastrointestinal perforation within  months prior to cycle  day \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 > . and aPTT > . x ULN within  days prior to cycle  day . History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding\r\n* Life expectancy of <  weeks\r\n* Any previous venous thromboembolism >= grade \r\n* Proteinuria at screening as demonstrated by urine dipstick >= + or -hour. proteinuria > . 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 (>=  continuous months of amenorrhea with no identified cause other than menopause) or surgically sterile must have a negative serum pregnancy test within  days prior to cycle  day 
Patients must have cHL that has not been previously treated (patients who have received one dose [day  cycle ] 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  cycle )
At cycle  day  pre-dosing: Creatinine >  x ULN
Surgery or local prostatic intervention (excluding a prostatic biopsy) less than  days of Cycle  Day .
Pediatric patients ?  day old on Cycle  Day  (CD)
Immunosuppressive therapy within  weeks of Cycle , Day 
Maintenance should commence within  days of recovery of peripheral blood counts after consolidation cycle ; patients must begin consolidation cycle  within  days of recovery to be eligible for further therapy
Immunosuppressive therapy within  weeks of Cycle , Day 
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 - h after drug administration on days  and  of cycle  as well as day  of cycle ; urine for assessment of ABT- renal clearance for  h after administration of drugs on days  and  of cycle  as well as day  of cycle ; and a pretreatment peripheral blood sample for possible sequencing of the BRCA, BRCA loci as well as possible pharmacogenomic analysis
Participants who have undergone a major surgical procedure or trauma within  weeks prior to cycle , day ; all wounds must be fully healed on cycle , day 
Patients who have had chemotherapy or immunotherapy within  weeks ( weeks for nitrosoureas or mitomycin C) or radiotherapy within  weeks prior to cycle  day ; patients who have had tyrosine kinase inhibitors (such as Braf or MEK inhibitors) within  days of cycle  day 
Participation in an investigational anti-cancer study within  weeks prior to cycle  day 
Patients must have begun cycle  (carfilzomib   mg/m^) and must not have received any dose reduction for toxicity in the last cycle of treatment, immediately preceding progression
Participants who are untreated or who received a maximum of one () cycle of combination chemotherapy, including rituximab-containing regimens, prior are eligible; the start of previous chemotherapy cycle must occur at least  days prior to beginning treatment under this protocol, and such cycle will count towards the total maximum of  cycles under this study
Has had minor surgery (i.e., simple excision, tooth extraction) < days prior to the first dose of study drug (Cycle , Day ).
Patient must be randomized within  weeks of the first day of the last cycle of chemotherapy
Clinically significant bleeding within  days of Cycle  Day  (Treatment Groups B and C only).
Subject has received radiotherapy or radiosurgery within  days prior to Cycle  Day ;
Clinically significant bleeding within  days of Cycle  Day 
Agree to provide core biopsies at baseline and at Cycle  Day 
Receipt of any anti-cancer drug/biologic or investigational treatment within  days prior to Cycle  Day  except hormone therapy, which can be given up to  days prior to Cycle  Day ; recovery of treatment related toxicity consistent with other eligibility criteria
Radiation therapy within  weeks prior to Cycle , Day 
Malignancies other than disease under study within  years prior to Cycle , Day 
Prior anti-cancer therapy within  weeks prior to Day  of Cycle 
Prior radiation therapy within  weeks prior to Day  of Cycle 
A bone marrow biopsy must be performed within four weeks prior to Cycle  Day  treatment to establish the baseline fibrosis score;
Patients must have been off of chemotherapy for at least  weeks prior to day  of cycle ; informed consent can be signed at any time prior to the start of therapy
Significant cardiac event within  months before Cycle  Day .
Current or recent (within  calendar days prior to cycle , day ) 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  months prior to Day  of Cycle , treatment with a monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within  weeks prior to Day  of Cycle , radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within  weeks prior to Day  of Cycle 
Participant has received anti-myeloma treatment within  weeks before Cycle  Day 
Any radiation treatment to metastatic site within  days of Cycle , Day 
Administration of intravesical bacillus Calmette-Guerin (BCG) within  weeks before cycle , day 
Any approved anti-cancer therapy within  weeks prior to enrollment with the following exceptions: \r\n* Palliative radiotherapy for bone metastases must be completed >  days prior to baseline imaging and >  days prior to cycle  day  of treatment\r\n* Hormone replacement therapy or oral contraceptives are permitted \r\n* Administration of intravesical bacillus Calmette-Guerin (BCG) >  weeks before cycle , day  is allowed
Any approved anti-cancer therapy within  weeks prior to enrollment o Administration of intravesical bacillus Calmette-Guerin (BCG) >  weeks before cycle , day  is allowed
Subject consents to hospitalization for first (Cycle  Day ) dose of CC- and for  hours after.
Participation in an investigational anti-cancer study within  weeks prior to cycle  day 
Severe infections within  weeks prior to Cycle , Day 
Received crizotinib within  days of the first dose of brigatinib (Day , Cycle ).
Thromboembolism within  months of cycle , day 
No treatment with cytotoxic therapy or monoclonal antibodies within  days prior to cycle  day 
No treatment with a steroid intended to treat myeloma within  days prior to cycle  day 
Severe infections within  weeks prior to Cycle  Day 
Radiation therapy for treatment of the primary tumor within  weeks of cycle , day 
Radiation or radionuclide therapy for treatment of metastatic CRPC tumor within  or  weeks, respectively, of cycle , day 
Prior flutamide (Eulexin) treatment within  weeks of cycle , day  (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 , day )
Bicalutamide (Casodex), nilutamide (Nilandron) within  weeks of cycle  day  (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 , day )
Subjects must have platelet count greater than , per microliter at baseline and at the start of study (day , cycle ) visit
Radiotherapy or systemic therapy within  weeks of Cycle  Day  (CD)
Cytotoxic therapy or monoclonal antibodies within  days prior to cycle  day 
At least  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 ?  weeks before Cycle  Day .
Received the last dose of previous treatment / therapy before Day  of cycle :
Subject has adequate biological parameters as demonstrated by the following blood counts at screening (obtained ?  days prior to starting Cycle  Day ):
Subject has the following blood chemistry levels at screening (obtained ?  days prior to starting Cycle  Day ):
Significant or symptomatic amounts of ascites should be drained prior to Cycle  Day
At least  days must have elapsed prior to Day  Cycle , since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least  days must have elapsed prior to Day  Cycle  since \limited palliative radiotherapy\, defined as a course of therapy encompassing <% total bone marrow volume and not exceeding  GY.
Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the  weeks prior to Cycle  Day 
Any malignancy within  years prior to Cycle , Day 
Anti-cancer therapy within the period immediately before Cycle  Day 
Malignancies other than UC within  years prior to Cycle , Day 
Systemic cytotoxic therapies or radiotherapy ? days prior to day  cycle 
For two weeks prior to day  cycle , administration of specified cytochrome P A (CYPA) inducers
At least  days must have elapsed prior to day  cycle , from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least  days must have elapsed prior to Day  Cycle  for \limited palliative radiotherapy\, defined as a course of therapy encompassing < % total bone marrow volume and not exceeding  Gy.
Adequate bone marrow, liver, and renal function within the  days prior to Day  of Cycle  of study drug up until pre-dose of Cycle 
Participants with persistent phosphate greater than upper limit of normal during screening (within  days prior to Day  of Cycle  up until pre-dose of Cycle ) and despite medical management of phosphate levels
Small molecular cell cycle inhibitors >=  weeks from registration
Antithymocyte globulin or similar anti-T cell antibody therapy ?  weeks prior to Cycle  Day 
Severe infections within  weeks prior to Cycle , Day 
Neutrophil count < .  ^/liter (L) prior to dosing on Cycle  Day 
Platelet count ?   ^/L prior to dosing on Cycle  Day 
Prior anti-cancer therapy or radiotherapy within  weeks prior to Day  of Cycle 
? weeks for cytotoxic therapy (except hydroxyurea, which is permitted at doses of ?g/day during the first  weeks of Cycle ) prior to CD.
Treatment with demethylating agents within  days prior to Cycle , Day 
Participation in an investigational anti-cancer study =<  weeks prior to cycle day 
CYCLE II PORTION ONLY: Only participants with a nausea score >=  at least once on the diary assessment from cycle  can be randomized for cycle 
CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 
CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 
CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 
th or later cycle of intravenous carboplatin or oxaliplatin infusion planned or  months after the first cycle of agent (whichever is of longer duration) =<  days after registration
Study participation will occur during the first cycle of  day temozolomide course
History of intra-abdominal inflammatory process within  months prior to Day  of Cycle 
Treatment with any HCV anti-viral therapy within  weeks prior to Cycle  Day 
Prior anti-cancer therapy within  weeks prior to Cycle , Day 
If currently menstruating, must know the date of the first day of their latest menstrual cycle
Inclusion Criteria:\n\n        Cycle :\n\n        The following inclusion criteria must be checked prior to inclusion at Cycle :\n\n          . 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          . Female patient of at least  years of age.\n\n          . Histologically or cytologically confirmed breast cancer, including recurrent or\n             metastatic.\n\n          . Nave to moderately or highly emetogenic antineoplastic agents.\n\n          . Scheduled to receive at least  consecutive cycles of an AC combination regimen.\n\n             Notes:\n\n               . additional not emetogenic, minimally or low emetogenic antineoplastic agents are\n                  permitted at any time after start of AC combination on Day .\n\n               . additional highly or moderately emetogenic antineoplastic agents are only allowed\n                  on Day  after the start of AC combination, provided their administration is\n                  completed within  hours from the start of the AC combination administration.\n\n          . ECOG Performance Status of  or .\n\n          . 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  hours prior to dose of investigational product.\n\n             Notes:\n\n               . Female patients of non-childberaring potential are defined as being in\n                  post-menopausal state since at least  year; or having documented surgical\n                  sterilization or hysterectomy at least  months before study participation.\n\n               . Reliable contraceptive measures include implants, injectables, combined oral\n                  contraceptives, intrauterine devices, vasectomized partner or complete (long\n                  term) sexual abstinence;\n\n          . Hematologic and metabolic status adequate for receiving a cycle of AC chemotherapy\n             based on investigator's assessment.\n\n          . 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         . 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  of Cycle ); inclusion\n        criteria  will be re-checked at Day  (Visit ).\n\n        Cycles  to :\n\n        The following inclusion criteria must be checked prior to inclusion at each repeated cycle:\n\n          . 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          . Scheduled to receive an AC chemotherapy regimen or AC chemotherapy together with other\n             chemotherapies as defined in Inclusion criterion # for Cycle .\n\n          . 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  hours prior to dosing of investigational product.\n\n          . 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 ); inclusion criterion #\n        will be re-checked at Day  (Visit ).\n\n        Exclusion Criteria:\n\n        Cycle :\n\n        The following exclusion criteria must be checked prior to inclusion at Cycle :\n\n          . Lactating patient.\n\n          . Current use of illicit drugs or current evidence of alcohol abuse.\n\n          . Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition\n             to the AC regimen, from  hours after the start of the AC chemotherapy on Day  and up\n             to Day  of Cycle .\n\n          . Received or is scheduled to receive radiation therapy to the abdomen or the pelvis\n             within  week prior to the start of AC chemotherapy administration on Day  or between\n             Days  to , inclusive.\n\n          . Any vomiting, retching, or nausea (grade  as defined by National Cancer Institute)\n             within  hours prior to the start of AC chemotherapy administration on Day .\n\n          . Symptomatic primary or metastatic central nervous system (CNS) malignancy.\n\n          . 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          . Known hypersensitivity or contraindication to  hydroxytryptamine type  (-HT)\n             receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron,\n             tropisetron, ramosetron), to dexamethasone, or to neurokinin- (NK) receptor\n             antagonists (e.g., aprepitant, rolapitant).\n\n          . Known contraindication to the IV administration of  mL % glucose solution.\n\n         . Participation in a previous clinical trial involving IV fosnetupitant or oral\n             netupitant administered alone or in combination with palonosetron.\n\n         . Any investigational drugs taken within  weeks prior to Day , 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         . Systemic corticosteroid therapy within  hours prior to the start of AC chemotherapy\n             administration on Day , except the dexamethasone provided as additional study drug.\n             However, topical and inhaled corticosteroids are permitted.\n\n         . Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy\n             during the study participation.\n\n         . Other than as administered as part of the study protocol, any medication with known or\n             potential antiemetic activity within  hours prior to the start of AC chemotherapy\n             administration on Day , including:\n\n               -  -HT receptor antagonists (e.g., ondansetron, granisetron, dolasetron,\n                  tropisetron, ramosetron, palonosetron)\n\n               -  NK 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 ).\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         . Scheduled to receive any strong or moderate inhibitor of CYPA during the efficacy\n             assessment period (Day  to Day , inclusive) or its intake within  week prior to Day\n             .\n\n         . Scheduled to receive any CYPA inducer during the efficacy assessment period (Day \n             to Day , inclusive) or its intake within  weeks prior to Day , with the exception\n             of corticosteroids (for which exclusion criterion # applies).\n\n         . History or predisposition to cardiac conduction abnormalities, except for incomplete\n             right bundle branch block.\n\n         . History of risk factors for Torsades de Pointes (heart failure, hypokalemia, family\n             history of Long QT Syndrome).\n\n         . Severe or uncontrolled cardiovascular diseases, including myocardial infarction within\n              months prior to Day , 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 #, #, and # will be checked at\n        screening visit (Visit ). Exclusion criteria #, #, and # will be checked at Day \n        (Visit ) only.\n\n        Exclusion criteria #, #, #, #, #, #, and # need to be re-checked at Day  (Visit\n        ).\n\n        Cycles  to :\n\n        The following exclusion criteria must be checked prior to inclusion at each repeated cycle:\n\n          . Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition\n             to the AC regimen, from  hours after the start of the AC chemotherapy on Day  of\n             current cycle and up to Day  of the next cycle.\n\n          . Active infection or uncontrolled disease that may pose unwarranted risks in\n             administering the study drugs to the patient.\n\n          . Started any of the prohibited medications.\n\n          . Any vomiting, retching, or nausea (grade ?  as defined by National Cancer Institute)\n             within  hours prior to the start of AC chemotherapy administration on Day .\n\n          . Received or is scheduled to receive radiation therapy to the abdomen or the pelvis\n             within  week prior to the start of AC chemotherapy administration on Day  or between\n             Days  to .\n\n          . Symptomatic primary or metastatic CNS malignancy.\n\n          . 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 #, will be checked at screening visit\n        (Visit ). Exclusion criterion # will be checked at Day  (Visit ) only. Exclusion\n        criteria #, # and # need to be re-checked at Day  (Visit ).
Patient must start everolimus mg plus exemestane mg treatment on Cycle  Day  of trial
Patients that may need dose reduction to commence cycle  treatment
Washout period prior to Day  Cycle :
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  week course of continuous daily temozolomide\r\n* At least six -day cycles given in one of the following schedules:\r\n** Daily for  days of a -day cycle\r\n** Daily for  days of a -day cycle\r\n** Daily for  days of a -day cycle\r\n** Alternating  days on/ days per -day cycle\r\n** Continuous daily dosing of a -day cycle\r\n* Other schedules of temozolomide may be considered after discussion with the overall principal investigator\r\n* At least  cycles of PCV or lomustine (CCNU) chemotherapy