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NCT04673448 · ClinicalTrials.gov registry record · Phase 1
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by University of Washington.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04673448: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by University of Washington.
NCT04673448 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8 that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 18 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04673448, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by University of Washington.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as TSR-042, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and TSR-042 may kill more cancer cells.
Primary Outcome
Will be defined as a complete response (CR) or partial response (PR), confirmed and unconfirmed, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 using investigator's review.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Niraparib
- BIOLOGICAL Dostarlimab
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What the registry record for NCT04673448 still lists
NCT04673448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (91% lower).
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04673448 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04673448 about?
NCT04673448 is a clinical study titled "Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer". This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Niraparib is an inhi...
What is the current status of trial NCT04673448?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-10-18. Estimated completion is 2026-09-30.
What conditions does trial NCT04673448 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Pancreatic Carcinoma.
What interventions are being tested in trial NCT04673448?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Niraparib (DRUG), Dostarlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04673448?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04673448 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04673448's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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