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NCT05276973 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer
A Phase 1 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 8
- Study locations
NCT05276973: Active Phase 1 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT05276973 is a Phase 1 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 25 participants, below the 300-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05276973, a Phase 1 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 8
- Study locations
Study Summary
This phase I/IB trial tests the safety, side effects, and best dose of ipatasertib in combination with paclitaxel and carboplatin in treating patients with stage III or IV epithelial ovarian cancer. Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving ipatasertib in combination with paclitaxel and carboplatin may lower the chance of the tumor growing or spreading for longer than the paclitaxel and carboplatin alone.
Primary Outcome
The incidence of DLTs was assessed based on the number of participants who experienced at least one dose-limiting toxicity (DLT) during the Dose Escalation phase, which was used to estimate the maximum tolerated dose (MTD). A DLT was defined as any protocol-specified adverse event that was possibly, probably, or definitely related to study drug combination and occurred during the first cycle of neoadjuvant chemotherapy, unless the event was clearly unrelated to the study therapy. Adverse events
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Ipatasertib
- PROCEDURE Biopsy
- DRUG Paclitaxel
Study Locations (8)
California
- UCSF Medical Center-Mission Bay - San Francisco
Georgia
- Augusta University Medical Center - Augusta
Ohio
- Cleveland Clinic Foundation - Cleveland
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Rhode Island
- Women and Infants Hospital - Providence
Virginia
- Virginia Commonwealth University/Massey Cancer Center - Richmond
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-09-08 |
| Est. Completion | 2026-02-26 |
| Phase | Phase 1 |
What the registry record for NCT05276973 still lists
NCT05276973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 300-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with Ovarian Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT05276973 lists 8 locations in 8 states (California, Georgia, Ohio).
Frequently Asked Questions
What is clinical trial NCT05276973 about?
NCT05276973 is a clinical study titled "Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer". This phase I/IB trial tests the safety, side effects, and best dose of ipatasertib in combination with paclitaxel and carboplatin in treating patients with stage III or IV epithelial ovarian cancer. Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth...
What is the current status of trial NCT05276973?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-09-08. Estimated completion is 2026-02-26.
What conditions does trial NCT05276973 study?
This clinical trial studies the following conditions: Ovarian Endometrioid Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Stage III Ovarian Cancer AJCC v8, Fallopian Tube High Grade Serous Adenocarcinoma.
What interventions are being tested in trial NCT05276973?
The interventions under investigation include: Carboplatin (DRUG), Ipatasertib (DRUG), Biopsy (PROCEDURE), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT05276973?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05276973 being conducted?
This trial has 8 study locations across California, Georgia, Ohio, Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05276973's enrollment target sits among peer trials
25 16th of 15 the lowest of 15 other Ovarian Endometrioid Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Endometrioid Adenocarcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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