Study on Biomarker-Guided New Cancer Treatments for Advanced or Returning Ovarian Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07060365

Provider View

This clinical trial is exploring new cancer treatments, either alone or in combination, for patients with advanced or returning ovarian cancer. The study aims to assess the safety and effectiveness of these treatments, guided by specific biomarkers.

Patient Parameters

Program Overview

The main goal of this study is to test the safety, tolerability, and initial effectiveness of new cancer treatments that are guided by specific biomarkers. These treatments may be given alone or in combination to patients with advanced or returning ovarian cancer. Substudy 1 focuses on testing a drug called saruparib in patients with a specific genetic mutation (BRCA) in their ovarian, fallopian tube, or primary peritoneal cancer.

Description

This study is divided into multiple parts and takes place at several locations. It uses a Master Protocol to guide different substudies. Substudy 1 is a single-arm study that tests the safety and effectiveness of saruparib, a new drug, in patients with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer who have a specific BRCA mutation. These patients are eligible for initial treatment before surgery to remove as much of the cancer as possible.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or returning ovarian, fallopian tube, or primary peritoneal cancer confirmed by lab tests.
  • Provide a tumor sample for biomarker testing.
  • Have a life expectancy of at least 12 weeks.
  • Have measurable cancer based on specific criteria.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have adequate organ and bone marrow function.

Substudy 1:

  • Have newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer with a specific BRCA mutation.
  • Have not received prior treatment for this cancer.

Exclusion Criteria

  • Have a history of severe blood cell deficiencies lasting more than 2 weeks.
  • Have untreated or unstable spinal cord compression or brain metastases.
  • Have active immune system deficiencies or infections.
  • Have a known tendency to bleed easily.
  • Have certain heart conditions or a history of heart disease.
  • Have had another cancer requiring treatment in the past 2 years.
  • Have had a bone marrow or organ transplant.
  • Have severe or uncontrolled diseases or infections.
  • Have allergies to the study drugs or their ingredients.
  • Are taking medications that affect heart rhythm.
  • Have had major surgery or significant injury recently.
  • Are receiving other cancer treatments.

Substudy 1:

  • Have a history of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Have severe nausea, vomiting, or digestive issues that prevent taking the study drug.

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