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NCT05691504 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers
A Phase 1 study of Recurrent Fallopian Tube Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 6
- Study locations
NCT05691504: Recruiting Phase 1 study of Recurrent Fallopian Tube Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05691504 is a Phase 1 study of Recurrent Fallopian Tube Carcinoma and Recurrent Primary Peritoneal Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 228-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (82% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05691504, a Phase 1 study of Recurrent Fallopian Tube Carcinoma and Recurrent Primary Peritoneal Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of combination therapy with pelcitoclax (APG-1252) and cobimetinib in treating patients with ovarian and endometrial cancers that have come back after a period of improvement (recurrent). APG-1252 is a drug that inhibits activity of proteins that prevent cell death, leading to increased cell death and reduced cell growth. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving APG-1252 in combination with cobimetinib may shrink or stabilize tumor in patients with recurrent ovarian and endometrial cancers.
Primary Outcome
Will be identified using a Bayesian optimal interval design.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- DRUG Cobimetinib
Study Locations (6)
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
- National Cancer Institute Developmental Therapeutics Clinic - Bethesda
- National Institutes of Health Clinical Center - Bethesda
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Massachusetts
- Dana-Farber Cancer Institute - Boston
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-09-14 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 1 |
What NCT05691504 shows while recruiting
NCT05691504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 228-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (82% lower).
The record links to 10 conditions, with Recurrent Fallopian Tube Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05691504 lists 6 locations in 4 states (Maryland, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05691504 about?
NCT05691504 is a clinical study titled "Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers". This phase I trial tests the safety, side effects, and best dose of combination therapy with pelcitoclax (APG-1252) and cobimetinib in treating patients with ovarian and endometrial cancers that have come back after a period of improvement (recurrent). APG-1252 is a drug that inhibits activity of pr...
What is the current status of trial NCT05691504?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2023-09-14. Estimated completion is 2027-02-01.
What conditions does trial NCT05691504 study?
This clinical trial studies the following conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Endometrial Carcinoma, Advanced Endometrial Carcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma.
What interventions are being tested in trial NCT05691504?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT05691504?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05691504 being conducted?
This trial has 6 study locations across Georgia, Maryland, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Fallopian Tube Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05691504's enrollment target sits among peer trials
42 21st of 35 higher than 15 of 35 other Recurrent Fallopian Tube Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Fallopian Tube Carcinoma 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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