Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations

Conditions

• Bile Duct Adenocarcinoma
• Fanconi Anemia Complementation Group Gene Mutation
• Metastatic Bile Duct Carcinoma
• PTEN Gene Deletion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood and tissue samples
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Olaparib — DRUG
  Given PO

Study Details

This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date

Jun 24, 2020

Status verified

Apr 2026

Primary completion

Mar 12, 2025

Completion

Aug 30, 2026

Study Design

Enrollment

32 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (olaparib)
  Patients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial, and collection of blood and tissue samples on study.

Primary Outcome Measure

Number of Patients Alive and Progression-free at First Scan [ Time Frame: 8 weeks ]

Locations (5)

Find similar trials in Scottsdale, AZ

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