Study on Adavosertib With or Without Olaparib for Treating Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03579316

Provider View

This clinical trial is exploring how well the drugs adavosertib and olaparib work, either alone or together, in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has returned after previous treatment.

Patient Parameters

Program Overview

The purpose of this study is to see if the drugs adavosertib and olaparib can help stop the growth of cancer cells in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back. These drugs work by blocking certain enzymes that cancer cells need to grow.

Description

The main goal of this study is to find out how well adavosertib, alone or with olaparib, can shrink tumors in women with recurrent ovarian cancer who have already been treated with a PARP inhibitor. The study also aims to assess the safety and side effects of these drugs, how long patients can live without the cancer getting worse, and how long they survive overall. Researchers will also look at how the drugs work in patients with specific genetic mutations and how the cancer cells respond to the treatment.

Participants will be randomly assigned to one of three groups:

  • Group 1: Patients will take adavosertib by mouth once a day for five days, followed by a break, and then another five days of treatment. This cycle repeats every 21 days as long as the treatment is effective and side effects are manageable.

  • Group 2: Patients will take olaparib by mouth twice a day for 21 days and adavosertib once a day for three days, followed by a break, and then another three days of treatment. This cycle repeats every 21 days as long as the treatment is effective and side effects are manageable.

  • Group 3: Patients will take ceralasertib tablets twice a day for 14 days and olaparib tablets twice a day for 28 days.

After finishing the study treatment, patients will be monitored for 30 days and periodically afterwards to check their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Understand and agree to the study requirements and provide written consent.
  • Have recurrent ovarian, primary peritoneal, or fallopian tube cancer with no curative treatment options.
  • Cancer must have progressed while on or shortly after PARP inhibitor therapy.
  • Have at least one tumor that can be measured by scans.
  • Provide a tumor sample collected before previous PARP therapy.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have adequate organ and bone marrow function based on specific blood tests.
  • Women must not be pregnant, must agree to use contraception, and have a negative pregnancy test before starting treatment.
  • Be 18 years or older.
  • Willing to follow study procedures and attend follow-up visits.

For ceralasertib arm only:

  • Have platinum-sensitive cancer, meaning no recurrence for more than 6 months after last platinum-based therapy.
  • Have a BRCA mutation or HRD positive status.
  • Have shown benefit from previous PARP inhibitor treatment.

Exclusion Criteria

  • Recent treatment with a PARP inhibitor or other cancer therapies without a sufficient break before starting the study drugs.
  • Recent major surgery or unresolved side effects from previous treatments.
  • Difficulty swallowing pills or gastrointestinal issues affecting drug absorption.
  • Uncontrolled brain metastases or recent brain radiation.
  • Use of certain medications that interact with the study drugs.
  • Known allergies to study drugs.
  • Serious heart conditions or risk factors for heart rhythm problems.
  • Pregnant or breastfeeding women.
  • Serious infections or other medical conditions that could interfere with the study.
  • Other active cancers or recent cancer treatments.

For ceralasertib arm only:

  • Use of certain medications that affect liver enzymes involved in drug metabolism.
  • Uncontrolled high blood pressure or other specific health conditions.

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