Testing the Addition of ASTX660 (Tolinapant) to the Usual Chemotherapy Treatment (Paclitaxel With or Without Bevacizumab) in Patients With Recurrent Ovarian Cancer

Summary

This phase I/II trial tests the safety, best dose and effectiveness of adding tolinapant (ASTX660) to paclitaxel with or without bevacizumab in treating patients with ovarian cancer that has come back after a period of improvement (recurrent). Tolinapant may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, that promote the growth of tumor cells and increase resistance to chemotherapy. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of tumor cells. Adding ASTX660 to paclitaxel with or without bevacizumab may be safe, tolerable and/or effective in treating patients with recurrent ovarian cancer.

Conditions

• Platinum-Refractory Fallopian Tube Carcinoma
• Platinum-Refractory Ovarian Carcinoma
• Platinum-Refractory Primary Peritoneal Carcinoma
• Recurrent Fallopian Tube Adenocarcinoma
• Recurrent Fallopian Tube Carcinosarcoma
• Recurrent Fallopian Tube Clear Cell Adenocarcinoma
• Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
• Recurrent Fallopian Tube Undifferentiated Carcinoma
• Recurrent High Grade Endometrioid Adenocarcinoma
• Recurrent Ovarian Adenocarcinoma
• Recurrent Ovarian Carcinosarcoma
• Recurrent Ovarian Clear Cell Adenocarcinoma
• Recurrent Ovarian High Grade Serous Adenocarcinoma
• Recurrent Ovarian Seromucinous Carcinoma
• Recurrent Ovarian Undifferentiated Carcinoma
• Recurrent Platinum-Resistant Fallopian Tube Carcinoma
• Recurrent Platinum-Resistant Ovarian Carcinoma
• Recurrent Platinum-Resistant Primary Peritoneal Carcinoma
• Recurrent Primary Peritoneal Adenocarcinoma
• Recurrent Primary Peritoneal Carcinosarcoma
• Recurrent Primary Peritoneal Clear Cell Adenocarcinoma
• Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma
• Recurrent Primary Peritoneal Undifferentiated Carcinoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

DRUG

Tolinapant

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Kristen P Zeligs · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-31

Primary Completion

2028-02-09

Completion

2028-02-09

FDA Drug

Yes