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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06393751
Phase
PHASE1/PHASE2
Status
Withdrawn

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Paclitaxel — DRUG
    Given IV
  • Tolinapant — DRUG
    Given PO

Study Details

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.

Key Dates

First listed
May 1, 2024
Start date
Oct 31, 2025
Status verified
Jun 2025
Primary completion
Feb 9, 2028
Completion
Feb 9, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I (paclitaxel, tolinapant, bevacizumab)
    Patients receive paclitaxel IV on days 1, 8 and 15, bevacizumab IV on days 1 and 15, and ASTX660 PO on days 1-7 and 15-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT and MRI throughout the study.
  • Active Comparator: Phase II, Arm I (paclitaxel, bevacizumab)
    Patients receive paclitaxel IV on days 1, 8, and 15 of each cycle. Patients may also receive bevacizumab IV on days 1 and 15 of each cycle per provider. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT and MRI throughout the study.
  • Experimental: Phase II, Arm II (paclitaxel, tolinapant, bevacizumab)
    Patients receive paclitaxel IV on days 1, 8, and 15 and ASTX660 PO on days 1-7 and 15-21 of each cycle. Patients may also receive bevacizumab IV on days 1 and 15 of each cycle per provider. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT and MRI throughout the study.

Primary Outcome Measure

Incidence of dose-limiting toxicity (Phase I) [ Time Frame: At 28 days ]

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