Testing Olaparib for Advanced or Metastatic Bladder Cancer and Other Genitourinary Tumors with DNA-Repair Genetic Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03375307

Provider View

This study is exploring how well the drug olaparib works in treating bladder cancer and other genitourinary tumors that have spread and have specific DNA-repair genetic changes. Olaparib is a PARP inhibitor that may help stop tumor growth by preventing cancer cells from repairing themselves.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of olaparib in patients with advanced or metastatic bladder cancer and other genitourinary tumors that have DNA-repair defects. These defects make it difficult for cancer cells to repair themselves, and olaparib, a PARP inhibitor, may help stop their growth. The study aims to see if olaparib can improve outcomes for these patients, who typically have cancer that cannot be cured or controlled with standard treatments.

Description

The main goal of this study is to see how well olaparib works in patients with advanced or metastatic non-prostate genitourinary cancers that have specific DNA-repair defects. Researchers will look at how many patients respond to the treatment.

Secondary goals include:

  • Understanding how the treatment affects the time patients live without the cancer getting worse and their overall survival.
  • Evaluating the safety and side effects of olaparib.
  • Following patients without the specific DNA-repair defects to see how long they survive.

The study will also explore:

  • The presence of DNA-repair mutations in patients with metastatic non-prostate genitourinary cancer.
  • The relationship between circulating tumor cells and patient survival.
  • Changes in tumor characteristics and immune response to treatment.
  • The effectiveness of using advanced sequencing techniques to identify DNA-repair defects.

Patients are divided into three groups:

  • Cohorts I and II: Patients with cancer-related DNA-repair gene mutations take olaparib pills twice daily in 28-day cycles, with regular scans and optional biopsies.
  • Cohort III: Patients without these mutations undergo regular scans and optional biopsies.

After treatment, patients are monitored regularly to track their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-prostate genitourinary cancer.
  • Have genetic mutations related to cancer in specific genes, as identified by a specialized test.
  • Have measurable disease, meaning at least one tumor that can be accurately measured.
  • Show evidence of disease progression after previous treatments.
  • Be 18 years or older.
  • Have a good performance status, meaning they are fully active or able to carry out light work.
  • Have adequate blood cell counts and organ function.
  • Be able to take oral medications.
  • Agree to use effective contraception during and after the study.
  • Understand and agree to the study requirements, including providing tumor samples for analysis.
  • Women must have a negative pregnancy test before starting treatment and meet specific criteria for non-childbearing potential.

Exclusion Criteria

  • Have had previous treatment with olaparib or other PARP inhibitors.
  • Have certain blood disorders or persistent side effects from previous cancer treatments.
  • Have known brain metastases or spinal cord compression.
  • Have allergies to olaparib or similar drugs.
  • Are taking medications that interact with olaparib.
  • Are pregnant or breastfeeding.
  • Have uncontrolled medical conditions, such as heart disease or infections.
  • Have a history of other cancers within the last two years, with some exceptions.
  • Have had major surgery or other treatments too close to the start of the study.

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