[c09aa8]: / clusters / clusters342final / clust_157.txt

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Prior treatment with a PARP inhibitor or topotecan
Patients who received and progressed on the combination of carboplatin/paclitaxel will not be eligible
Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration
Prior exposure to ABT888 or other PARP inhibitors is permitted in all cohorts except the cohort evaluating BRCA-mutated PARP inhibitor naive patients, where prior PARP inhibitor treatment will not be permitted; prior exposure to cyclin-dependent kinase inhibitors other than SCH727965 is permitted
Patients who have previously received SCH727965
Subjects on a potent CYP3A4 inhibitor or CPY3A4 inducer who cannot be changed to another medication are excluded
>= 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor, as measured by verbally addressing the following question: please rate your pain by picking a number, from 0 to 10 (0 being none and 10 being as bad as you can imagine) that best describes your pain from your aromatase inhibitor breast cancer medication on AVERAGE, over the past week* Note: Patients may, or may not, be taking non-opioid analgesics
Concurrent use of the aromatase inhibitor exemestane
Patients receiving histone deacetylase (HDAC) inhibitors or compounds with HDAC inhibitor like activity, such as valproic acid, are ineligible; patients who have received such agents may enroll on this study after a 14-day washout period
Patients who have received prior romidepsin use are eligible
No history of receiving endocrine therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures; these agents used previously as chemoprevention are allowed
The patients BRAF mutation status at position 600 must be known prior to enrollment; patients with V600E mutations are eligible if they have failed an approved BRAF inhibitor or MEK inhibitor therapy or have been offered an approved BRAF inhibitor or MEK inhibitor therapy and refused
Patients whose BRAF V600E mutation status is unknown, have the BRAF V600E mutation and are responding to a BRAF inhibitor or MEK inhibitor therapy, or have the BRAF V600E mutation and have not been offered the option of receiving a BRAF inhibitor or MEK inhibitor therapy for the treatment of their melanoma
Previous mitogen-activated protein kinase kinase (MEK) inhibitor use such as PD-0325901; CI1040; AS73026; GDC 0973; ARRY43182; GSK110212
Patients previously enrolled on this trial are ineligible
Patients progressing on a prior BRAF inhibitor-based therapy will be eligible, as are patients nave to BRAF inhibitor therapy; resistance to BRAF inhibitor-based therapy will be defined as progressive disease by RECIST 1.1 criteria while receiving therapy with a BRAF inhibitor (vemurafenib or dabrafenib, alone or in combination with a mitogen-activated protein kinase [MEK] inhibitor); this may be innate resistance (patients who never achieved a tumor response while on BRAF inhibitor therapy) or acquired resistance (progression after having a tumor response to BRAF inhibitor therapy); there will not be a period of break between progression on the prior BRAF inhibitor-based therapy and the start of dabrafenib, trametinib and GSK2141795
Patients must have received prior BRAF inhibitor therapy (e.g. dabrafenib, vemurafenib) within 56 days prior to registration; prior trametinib therapy is permitted; patients are not required to interrupt BRAF or MEK inhibitor therapy prior to the initiation of three agent combination therapy on study
Patients should not have taken valproic acid, another histone deacetylase (HDAC) inhibitor, for at least 2 weeks prior to enrollment
TREATMENT: Patients with ovarian cancer and breast cancer gene (BRCA) mutations must have received specific poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy; if these patients have other mutations of interest, they will be eligible to receive agents based on that mutation
TREATMENT: Patients with metastatic breast cancer and BRCA mutations must have received specific PARP inhibitor therapy; if these patients have other mutations of interest as defined in the protocol, they will be eligible to receive agents based on that mutation
TREATMENT: Patients who have had prior treatment with any PARP inhibitor in combination with temozolomide are ineligible to receive treatment with veliparib on this study; patients who have received prior temozolomide or PARP inhibitor with or without other chemotherapy/targeted agent aside from temozolomide should not be excluded solely because of receiving prior PARP inhibitor or temozolomide, unless it was in combination; patients who have received temozolomide with a PARP inhibitor in the past are eligible to participate but will not receive veliparib with temozolomide on study; such patients are eligible to receive other treatment regimens on study based on identified genetic mutations
TREATMENT: Patients who have received prior mitogen-activated protein kinase kinase (MEK) inhibitors would not be eligible to receive trametinib DMSO on study; if these patients have mutations of interest in pathways other than the rat sarcoma (RAS) pathway, they will be eligible to receive agents based on that mutation
Proteasome inhibitor naive or sensitive disease; proteasome inhibitor sensitive disease is defined as a PR or better to prior proteasome inhibitor-based therapy that is maintained for >= 60 days from the last dose of the proteasome inhibitor* A patient who receives induction therapy with lenalidomide, bortezomib and dexamethasone and achieves a PR or better but subsequently progresses on continued lenalidomide or lenalidomide-dexamethasone would be eligible provided the progression occurs 60 days or more after discontinuation of the bortezomib; similarly, ixazomib exposure is allowed provided they meet the definition of proteasome inhibitor sensitive disease
PHASE I SUBJECTS ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression
Prior therapy is allowed; for patients enrolled in the Phase II portion of the study, patients may have received prior immunotherapy (including high-dose IL-2, ipilimumab, nivolumab, and other anti-PD1/PDL1 antibodies) or chemotherapy; however prior navitoclax, BRAF inhibitor and/or MEK inhibitor therapy will not be allowed
Prior navitoclax, BRAF inhibitor, and MEK inhibitor is prohibited; (exceptions for Phase I are described above)
Patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for treatment of MDS or myeloproliferative neoplasm (MPN) (e.g. azacitidine, decitabine, histone deacetylase inhibitors, tyrosine kinase inhibitors, hematopoietic growth factors, interferon, lenalidomide, thalidomide) will be eligible for this trial as long as immunomodulatory drugs (e.g. lenalidomide, thalidomide) have not been used in the past 3 months
Patients previously treated with irinotecan are eligible for this study
Patients must not have received prior HSP90 inhibitor therapy
Patients who previously received gemcitabine for the treatment of recurrent disease
Patients may not have received prior MEK, v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), or v-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor therapy
Patients must have been previously treated with an immunomodulatory drug (IMiD) and proteasome inhibitor, must be refractory to carfilzomib defined as progression on or within 2 months of a carfilzomib-containing therapy, and must be progressing
Patients previously treated on clinical trial with reolysin
Metastases located within 3 cm of the previously irradiated structures:* Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)* Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)* Brain stem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)* Whole lung previously irradiated with prior volume 20 Gy (V20Gy) > 30% (delivered in =< 3 Gy/fraction)* Primary tumor irradiated with SBRT* Metastasis irradiated with SBRT
Patients must NOT be receiving valproic acid, an histone deacetylase (HDAC) inhibitor, and may not have previously received any HDAC inhibitor prior to enrollment (e.g. valproic acid, entinostat, vorinostat) unless discussed with the study chair; patients must not have received prior HDAC therapy for the treatment of their malignancy
Patients who have received prior therapy with a temozolomide-based regimen are eligible; Note: patients who have progressed on a poly adenosine diphosphate ribose polymerase (PARP) inhibitor and temozolomide regimen are not eligible for Part A of the study
PARP inhibitor exposure:* Part A: Patients who have received prior therapy with a PARP inhibitor, with the exception of BMN 673, are eligible; however, patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible* Part B and Part C: Patients who have previously been exposed to a PARP inhibitor are not eligible
Phase 1 (Part A): patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible
Phase 2 (Part B and Part C): patients who have previously been exposed to a PARP inhibitor are not eligible
Parts C, D, and E: patients who have received prior ipilimumab are not eligible
Patients must not have received a prior BRAF or mitogen-activated protein kinase kinase (MEK) inhibitor
Prior exposure to a Bruton agammaglobulinemia tyrosine-protein kinase (BTK) inhibitor
Metastases located within 3 cm of the previously irradiated structures:* Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)* Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)* Brainstem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)* Whole lung previously irradiated with prior V20Gy > 30% (delivered in =< 3 Gy/fraction)* Primary tumor irradiated with SBRT* Metastasis irradiated with SBRT
Renal cell patients must have had at least one prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
Patients who have previously received CDX-011 (glembatumumab vedotin) or other monomethyl auristatin E (MMAE)-containing agents
No prior proteasome inhibitor or immune-modulating drug (IMiD) use
Patients who have previously received denosumab
Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium
Patients may not have previously received a PARP inhibitor
Patients may not have previously received a PARP-inhibitor
Prior use of PARP-inhibitors
Prior therapy with AT13387 or another HSP90 inhibitor
Patients who have received prior inhibitor of VEGF signaling and a poly (ADP-ribose) polymerases (PARP) inhibitor administered in combination; unless administered in combination, patients who received a prior PARP inhibitor or a prior VEGF-signaling inhibitor agent are allowed after discussing with the PI
Patients who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent
Subjects who are unable to tolerate BRAF inhibitor and/or MEK inhibitor therapy due to grade >= 2 toxicity (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) from these agents, irrespective of antitumor response, are eligible on condition that: (a) toxicities persisted despite change from doublet to singlet therapy (i.e. from concurrent BRAF inhibition plus MEK inhibition to BRAF inhibition alone), (b) toxicities are attributed to a class effect, and therefore switch from one drug to another is expected to induce the same type of toxicity (e.g. ocular toxicities or cardiac dysfunction from MEK inhibitor), (c) drug-specific toxicities that do not resolve with switch from one BRAF inhibitor to another (i.e. dabrafenib to vemurafenib, or vice versa), will be eligible for enrollment in 9922; in other words, patients will be allowed to enroll into the NCI9922 study despite lack of progression to MAPK inhibitor treatments, on condition that grade 2 or higher toxicities attributed to MAPK inhibitors resolve to grade 1, or less, at the time of study enrollment
Patients must not have received prior cisplatin or poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors; prior carboplatin in the adjuvant/neoadjuvant setting and prior treatment with iniparib is allowed, if completed more than 6 months prior to study entry
Prior poly ADP ribose polymerase (PARP) inhibitor therapy is allowed; patients with ovarian cancer and a BRCA mutation should have had prior treatment with olaparib per guidelines for standard of care treatment
Patients must not have received prior PARP inhibitor therapy including, but not limited to ABT-888, olaparib, rucaparib, and talazoparib (BMN637)
Patients who have previously received alemtuzumab are ineligible
Currently using select CYP2D6 inhibitor or inducer medications
Metastases located within 3 cm of previously irradiated (< 3Gy per fraction) structures if not a candidate for surgery for these lesions and if:* Spinal cord previously irradiated to > 40 Gy* Brachial plexus previously irradiated to > 50 Gy* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy* Brainstem previously irradiated to > 50 Gy* Lung previously irradiated with prior V20 Gy > 35%
Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study
Previous MEK, retrovirus associated sequence (RAS), or RAF inhibitor use
Not previously received XL184 or another MET/HGF inhibitor (tivantinib or crizotinib); there are no limits on number of prior therapeutic regimens; patients who have been treated with prior VEGF pathway, or RET inhibitors (except XL184) may be eligible
Patients who have received a prior inhibitor of vascular endothelial growth factor (VEGF) signaling inhibitor, or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor administered
Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:* Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible* Patients who have received prior therapy with ABI-009 are not eligible* Patients who have previously received irinotecan and temozolomide in combination without progressive disease while on therapy are eligible* Patients who have previously received irinotecan and temozolomide in combination and had significant toxicity with these two drugs are not eligible* Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible
Patients who have been previously treated with inotuzumab ozogamicin
Patients must not have previously received a histone deacetylase (HDAC) inhibitor in a clinical trial setting (entinostat, romidepsin, belinostat, panobinostat, vorinostat)
Patients previously untreated or treated with drug therapy for epithelioid hemangioendothelioma (EHE) are eligible; there is no limit on the number of prior regimens used to be eligible
Prior systemic therapy with a MEK inhibitor