Study on Olaparib for Treating Patients with Metastatic Biliary Tract Cancer with DNA Repair Gene Mutations

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04042831

Provider View

This clinical trial is testing how well the drug olaparib works in treating patients with biliary tract cancer that has spread to other parts of the body and has specific DNA repair gene mutations. Olaparib may help stop tumor growth by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This phase II study is investigating the effectiveness of olaparib in patients with biliary tract cancer that has spread (metastatic) and has mutations in DNA repair genes. The drug olaparib may help stop the growth of cancer cells by blocking enzymes necessary for cell growth. The study will evaluate how long patients live without the cancer getting worse, overall survival, and the response of the cancer to the treatment. It will also assess the side effects experienced by patients.

Description

The main goal of this study is to see how effective olaparib is in treating advanced biliary tract cancer with DNA repair gene mutations. Researchers will look at how long patients live without the cancer getting worse and how long they survive overall. They will also measure how the cancer responds to the treatment and how long any positive response lasts. Additionally, the study will monitor the frequency and severity of any side effects.

Patients will take olaparib pills twice a day in 28-day cycles, continuing for up to 36 cycles unless the cancer progresses or side effects become unacceptable. Throughout the study, patients will have CT or MRI scans and provide blood and tissue samples for research.

After finishing the treatment, patients will have follow-up visits 30 days later and then every three months for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic biliary tract cancer.
  • Have specific genetic mutations related to DNA repair, such as mutations in BRCA1/2 or other similar genes.
  • Have measurable cancer that can be tracked.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have a life expectancy of at least 16 weeks.
  • Meet specific blood count and organ function criteria based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Must provide informed consent and be willing to return for follow-up visits.
  • Agree to provide blood and tissue samples for research purposes.
  • Patients with hepatitis B must be on antiviral therapy or monitored closely during treatment.

Exclusion Criteria

  • Have cancer that did not respond to platinum-based chemotherapy.
  • Have received other cancer treatments or major surgery within 28 days before starting the study.
  • Have certain heart conditions or uncontrolled high blood pressure.
  • Have a history of certain blood clots or ongoing infections.
  • Have brain tumors unless stable and treated more than six months ago.
  • Have a history of organ transplants or certain bleeding disorders.
  • Have severe kidney problems or dehydration.
  • Have a history of substance abuse or other conditions that may interfere with the study.
  • Be pregnant or breastfeeding, or unwilling to use contraception.
  • Have other serious medical conditions that could affect participation.
  • Be taking certain medications that interact with olaparib or affect heart rhythm.
  • Have had a blood transfusion within 120 days before the study.

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