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NCT05694715 · ClinicalTrials.gov registry record · Phase 1
Combination Therapy in Cancers With Mutations in DNA Repair Genes
A Phase 1 study of Metastatic Solid Tumor and BRCA1 Mutation, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05694715: Recruiting Phase 1 study of Metastatic Solid Tumor and BRCA1 Mutation, sponsored by University of California, San Francisco.
NCT05694715 is a Phase 1 study of Metastatic Solid Tumor and BRCA1 Mutation that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 24 participants, below the 192-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05694715, a Phase 1 study of Metastatic Solid Tumor and BRCA1 Mutation, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy. Emerging evidence suggest that PARPi is an effective therapeutic strategy in a wider subset of solid tumors that may have defective homologous recombination (HR) or DNA repair gene mutations. BReast CAncer gene (BRCA), partner and localizer of BRCA2 (PALB2), and various other DNA repair germline mutations predispose carriers to cancers of the breast, ovaries, pancreas, prostate and melanoma. A number of preclinical studies have demonstrated that PARP inhibitors can work as chemopotentiators. There is significant interest in this combination, and the recommended phase II dose will be used in the upcoming NCI ComboMatch trial.
Primary Outcome
The percentage of participants with treatment-emergent adverse events as classified and graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 will be reported
Conditions Studied
Interventions
- DRUG Irinotecan
- DRUG Niraparib
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-05-23 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
What NCT05694715 shows while recruiting
NCT05694715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 192-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (87% lower).
The record links to 5 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Irinotecan is the first listed.
NCT05694715 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05694715 about?
NCT05694715 is a clinical study titled "Combination Therapy in Cancers With Mutations in DNA Repair Genes". The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy. Emerging evidence suggest that PARPi is an effective therapeutic strategy in a wid...
What is the current status of trial NCT05694715?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-05-23. Estimated completion is 2028-01-31.
What conditions does trial NCT05694715 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, BRCA1 Mutation, BRCA2 Mutation, ATM Gene Mutation, PALB2 Gene Mutation.
What interventions are being tested in trial NCT05694715?
The interventions under investigation include: Irinotecan (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT05694715?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05694715 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05694715's enrollment target sits among peer trials
24 52nd of 52 higher than 1 of 52 other Metastatic Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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