Study on the Effectiveness and Safety of Olaparib in Patients with Advanced Cancer with Specific Genetic Mutations

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03742895

Provider View

This clinical trial is testing the drug Olaparib to see if it is safe and effective for patients with advanced cancers that have specific genetic mutations related to DNA repair. The study focuses on patients whose cancer has not responded to standard treatments or who cannot tolerate them.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well Olaparib works and how safe it is for patients with advanced cancers that cannot be surgically removed or have spread to other parts of the body. These patients have cancers that have specific genetic mutations affecting DNA repair, known as homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD). The study is for patients whose cancer has not improved with standard treatments or who cannot tolerate those treatments.

Eligibility Criteria

Inclusion Criteria

  • Have a type of cancer that can be measured by scans or tests.
  • Be able to provide a sample of the tumor for testing.
  • Have a life expectancy of at least 3 months.
  • Be in good overall health, with a performance status score of 0 or 1.
  • Male participants must agree to use contraception during the study and for 3 months after.
  • Female participants must not be pregnant or breastfeeding and must use effective contraception during the study and for 6 months after.
  • Have adequate organ function.
  • For non-breast or ovarian cancers with specific genetic mutations:
    • Have advanced cancer that cannot be cured and has not responded to standard treatments.
    • Have specific genetic mutations related to DNA repair.
  • For breast cancer with specific genetic mutations:
    • Have advanced breast cancer with specific genetic mutations.
    • Have received certain previous cancer treatments.

Exclusion Criteria

  • Have another active cancer that has required treatment in the last 5 years, except for certain skin or cervical cancers.
  • Have a blood disorder called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Have cancer that has spread to the brain or spinal cord, unless previously treated and stable.
  • Have received certain growth factors within 28 days before starting the study.
  • Have a history of HIV or active hepatitis B or C infection.
  • Have difficulty swallowing or a digestive disorder affecting medication absorption.
  • Have previously been treated with Olaparib or similar drugs.
  • Have had a bone marrow or double umbilical cord transplant.
  • Have received a whole blood transfusion in the last 120 days.
  • Have received cancer treatments within 3 weeks before starting the study.
  • Have an unknown primary cancer origin.
  • Have received radiation therapy within 2 weeks before starting the study.

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