--- a +++ b/clusters/9knumclustersv2/clust_1068.txt @@ -0,0 +1,35 @@ +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 months prior to study entry +Part , Cohort , Patients must have received ? prior treatment regimens for ovarian cancer including a platinum-based regimen. Patients whose OC harbors a mutation in breast cancer gene (BRCA), either germline or somatic, must have been previously treated with a poly(ADP ribose) polymerase (PARP) inhibitor, or be considered unwilling or ineligible for treatment with a PARP inhibitor +Patients previously treated with a poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitor may be enrolled provided:\r\n* PARP inhibitor was not the most recent treatment\r\n* PARP inhibitor treatment was discontinued > months before the first planned dose of rucaparib +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 +Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor +Prior treatment with poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors (example (e.g.), olaparib, veliparib [ABT-]) +Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor +Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor +Any previous treatment with poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, including olaparib +Received any prior poly ADP-ribose polymerase inhibitor (PARPi) treatment +Patients who are taking or anticipate taking any maintenance therapy while actively being treated on protocol or while being followed on protocol will be excluded; an example of this would be maintenance therapy with a Poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor such as olaparib +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 +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 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 +Participants with prior exposure to poly-ADP-ribose polymerase (PARP) inhibitors. +Prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor +Patients must have discontinued all biologic therapy at least days prior to registration; prior poly-adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors are allowed in the metastatic setting; prior PARP inhibitors in the neo/adjuvant setting are permissible; all toxicities related to prior biologic therapy must have resolved to CTCAE v. grade or lower +Participant has received prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor. +Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor. +Prior treatment with poly ADP ribose polymerase (PARP) inhibitors (eg., olaparib, ABT-) +Known allergic reaction or poor tolerability to poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors, carboplatin, or paclitaxel +Patients may not have received prior poly ADP ribose polymerase (PARP) inhibitors +Participants may not have had prior use of poly ADP ribose polymerase (PARP) inhibitors; patients may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, or sorafenib +All patients with ovarian, fallopian tube or primary peritoneal cancer and ovarian carcinosarcoma must have recurrent disease, and only one prior line of chemotherapy that must have been platinum-based chemotherapy for the management of primary disease; this initial platinum-based treatment may have included intraperitoneal therapy, consolidation/maintenance and/or biologic/targeted agents (e.g., bevacizumab, poly adenosine diphosphate [ADP] ribose polymerase [PARP] inhibitor) as part of first-line treatment +Patients may have unlimited prior chemotherapeutic regimens for management of recurrent locally advanced endometrial carcinoma, recurrent ovarian carcinoma, or metastatic triple negative breast cancer; treatment as frontline therapy for metastatic disease is acceptable; patients who have received prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors, MTOR inhibitors, and/or AKT inhibitors are allowed to participate; patients may have progressed on prior PARP inhibitor, MTOR inhibitor, or AKT inhibitor but they may not have discontinued drug for toxicity +Patients who have received prior bevacizumab (or any other vascular endothelial growth factor [VEGF] targeted agent) or prior poly ADP ribose polymerase (PARP) inhibitor +Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor. +Prior treatment with poly ADP ribose polymerase (PARP) inhibitors (e.g., olaparib, ABT-). +Prior exposure to PARP (poly ADP-ribose polymerase) inhibitors +Prior treatment with a known poly (ADP-ribose) polymerase (PARP) inhibitor +Prior treatment with a known poly (ADP-ribose) polymerases (PARP) inhibitor +Prior treatment with talazoparib or a poly(adenosine diphosphate [ADP]-ribosyl)ation (PARP)/ inhibitor; prior treatment with other agents that inhibit deoxyribonucleic acid (DNA) repair (i.e. WEE homolog [S. pombe] [WEE] inhibitors, ataxia telangiectasia mutated [ATM] inhibitors), is allowed; if there are any questions, please contact the study's principal investigator +Prior allergic reaction or severe intolerance (meeting the criteria for a serious adverse event, a grade or AE, or permanent treatment discontinuation) to a poly ADP ribose polymerase (PARP) inhibitor. +Prior allergic reaction or severe intolerance (meeting the criteria for a serious adverse event, a grade or AE, or permanent treatment discontinuation) to a poly ADP ribose polymerase (PARP) inhibitor. +Treatment with a prior investigational agent within days of planned instillation of NanoPac, with the exception of subjects participating in poly (ADP-ribose) polymerase (PARP) inhibitor trials. These subjects must discontinue the investigational agent prior to surgery