Active — Not RecruitingPhase 1

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

United States25 participantsStarted 2022-09-08

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pathologically proven diagnosis of ovarian cancer (ovarian cancer = fallopian tube cancer, ovarian cancer, primary peritoneal cancer). Required data element: submission of pathology report. Patients with the following histologic cell types are eligible: * High grade serous * Endometrioid adenocarcinoma, grade 3 Genomic/genetic testing results will be a data collection element if performed as part of usual care (germline genetic testing, tumor genomic testing, homologous recombination deficiency \[HRD\] testing). Genetic/genomic testing results should be uploaded if they become available anytime during conduct of the study * Appropriate stage for study entry defined as stage III or stage IV based on the following diagnostic workup: * History/physical examination within 14 days prior to registration * Imaging with computed tomography (CT) chest/abdomen/pelvis (C/A/P) within 28 days prior to registration * Patients must have evaluable disease or measurable disease defined by RECIST version (v) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI * Pre-treatment formalin-fixed, paraffin-embedded (FFPE) tumor block collected from laparoscopy (preferred) or five 18G cores by radiology/interventiona…

What they're measuring

Incidence of Dose Limiting Toxicities (DLTs) During Dose Escalation Phase

Timeframe: First cycle of 21 days

Incidence of Dose-limiting Toxicities (DLTs) During Dose Expansion Phase

Timeframe: First cycle of 21 days

Incidence of Grade 3 or Higher Adverse Events (AEs)

Timeframe: During treatment period and up to 90 days after the last dose of ipatasertib. The median duration of study treatment was 68 days with a range from 1 day to 90 days.

Trial details

NCT IDNCT05276973

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-01-30

Results submitted2025-10-10

View on ClinicalTrials.gov More Fallopian Tube Endometrioid Adenocarcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of Dose Limiting Toxicities (DLTs) During Dose Escalation Phase

Timeframe: First cycle of 21 days

Incidence of Dose-limiting Toxicities (DLTs) During Dose Expansion Phase

Timeframe: First cycle of 21 days

Incidence of Grade 3 or Higher Adverse Events (AEs)

Timeframe: During treatment period and up to 90 days after the last dose of ipatasertib. The median duration of study treatment was 68 days with a range from 1 day to 90 days.