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NCT06177171 · ClinicalTrials.gov registry record · Phase 1
Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors
A Phase 1 study of BRCA1 Mutation and BRCA2 Mutation, sponsored by Pamela Munster.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06177171: Recruiting Phase 1 study of BRCA1 Mutation and BRCA2 Mutation, sponsored by Pamela Munster.
NCT06177171 is a Phase 1 study of BRCA1 Mutation and BRCA2 Mutation that is actively recruiting participants, run by Pamela Munster. The registered enrollment target is 18 participants, below the 576-participant average among 15 other BRCA1 Mutation trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06177171, a Phase 1 study of BRCA1 Mutation and BRCA2 Mutation, is actively recruiting participants, sponsored by Pamela Munster.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single center, phase I/Ib clinical trial evaluating the combination of the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor olaparib with the DNA methyltransferase (DNMT) inhibitor ASTX727, which is an oral formulation of decitabine with cedazuridine (a cytidine deaminase inhibitor that allows for oral administration). The study population consists of adults with advanced/metastatic solid tumor malignancies with germline or somatic mutations in the HRR pathway (i.e., BReast CAncer gene 1 (BRCA1), BReast CAncer gene 2(BRCA2), Partner And Localizer of BRCA2 (PALB2), ATM, and/or Checkpoint kinase 2 (CHEK2) mutations).
Primary Outcome
Adverse events will be classified and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and reported by dose level.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG ASTX727
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-02-07 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
What NCT06177171 shows while recruiting
NCT06177171 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 576-participant average among 15 other BRCA1 Mutation trials with a reported enrollment target (97% lower).
The record links to 6 conditions, with BRCA1 Mutation appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.
NCT06177171 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06177171 about?
NCT06177171 is a clinical study titled "Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors". This is a single center, phase I/Ib clinical trial evaluating the combination of the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor olaparib with the DNA methyltransferase (DNMT) inhibitor ASTX727, which is an oral formulation of decitabine with cedazuridine (a cytidine deaminase inhi...
What is the current status of trial NCT06177171?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-02-07. Estimated completion is 2028-01-31.
What conditions does trial NCT06177171 study?
This clinical trial studies the following conditions: BRCA1 Mutation, BRCA2 Mutation, ATM Gene Mutation, BRCA Mutation, PALB2 Gene Mutation.
What interventions are being tested in trial NCT06177171?
The interventions under investigation include: Olaparib (DRUG), ASTX727 (DRUG).
Who is sponsoring clinical trial NCT06177171?
This trial is sponsored by Pamela Munster, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06177171 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 NCT06177171's enrollment target sits among peer trials
18 15th of 15 higher than 1 of 15 other BRCA1 Mutation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other BRCA1 Mutation 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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