Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Metastatic Ovarian Carcinoma
- Unresectable Primary Peritoneal Carcinoma
- Unresectable Malignant Solid Neoplasm
- Unresectable Pancreatic Carcinoma
- Unresectable Ovarian Carcinoma
- Metastatic Pancreatic Carcinoma
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Prognostic Stage IV Breast Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- BRCA-Mutated Malignant Neoplasm
- BRCA-Mutated Metastatic Breast Carcinoma
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Unresectable Breast Carcinoma
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- BRCA-Mutated Ovarian Carcinoma
- Metastatic Breast Carcinoma
- Prognostic Stage III Breast Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Metastatic Fallopian Tube Carcinoma
- Metastatic Primary Peritoneal Carcinoma
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Unresectable Fallopian Tube Carcinoma
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Metastatic Malignant Solid Neoplasm
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Stage III Fallopian Tube Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OUTLINE: Patients receive niraparib orally (PO) once daily (QD) on days 1-28 of cycle 1. Beginning cycle 2, patients receive niraparib PO QD on days 1-21 and dostarlimab intravenously (IV) on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable to...
OUTLINE: Patients receive niraparib orally (PO) once daily (QD) on days 1-28 of cycle 1. Beginning cycle 2, patients receive niraparib PO QD on days 1-21 and dostarlimab intravenously (IV) on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 6, patients receive niraparib PO QD on days 1-42 and dostarlimab IV on day 1. Cycles repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, every 6 months for 2 years, and then annually for up to 5 years.
Tracking Information
- NCT #
- NCT04673448
- Collaborators
- GlaxoSmithKline
- Investigators
- Principal Investigator: Elizabeth M. Swisher Fred Hutch/University of Washington Cancer Consortium
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