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Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer

NCT05276973 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-19

Study results available
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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.

Conditions

  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube High Grade Serous Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Primary Peritoneal High Grade Serous Adenocarcinoma
  • Stage III Fallopian Tube Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Primary Peritoneal Cancer AJCC v8
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Unresectable Fallopian Tube Endometrioid Adenocarcinoma
  • Unresectable Fallopian Tube High Grade Serous Adenocarcinoma
  • Unresectable Ovarian Endometrioid Adenocarcinoma
  • Unresectable Ovarian High Grade Serous Adenocarcinoma
  • Unresectable Primary Peritoneal Endometrioid Adenocarcinoma
  • Unresectable Primary Peritoneal High Grade Serous Adenocarcinoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy

DRUG

Carboplatin

Given IV

DRUG

Ipatasertib

Given PO

DRUG

Paclitaxel

Given IV

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Katherine C Fuh · NRG Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2025-01-30
Completion
2026-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276973 on ClinicalTrials.gov