NCT04042831

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

A Phase II Study of Olaparib in Patients With Advanced Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the efficacy (progression free survival \[PFS\] rate at first scan) of olaparib monotherapy in advanced biliary tract cancer (BTC) with mutations in deoxyribonucleic acid (DNA) repair genes. SECONDARY OBJECTIVES: I. To determine the overall survival of patients with advanced biliary tract cancer with mutations in DNA repair genes treated with olaparib. II. To determine the progression free survival of patients with advanced biliary tract cancer with mutations in DNA repair genes treated with olaparib. III. To determine the objective response of patients with advanced biliary tract cancer with mutations in DNA repair genes treated with olaparib. IV. To assess the duration of response for patients with advanced biliary tract cancer with mutations in DNA repair genes treated with olaparib who experience an objective response. V. To assess the frequency and severity of adverse events in advanced biliary tract cancer patients treated with olaparib. CORRELATIVE RESEARCH OBJECTIVES: I. Determine the prevalence of mutations including those targeting DNA repair pathways. II. Identify mutational signatures associated with pathogenic process in advanced biliary tract cancer samples. III. Correlate the presence of mutations and mutational signatures linked to mutations in DNA repair genes and homologous recombinant repair with clinical responses to olaparib. IV. To evaluate putative biomarkers related to: Iva. De novo sensitivity. IVb. Tumor evolution and resistance, to PARP inhibition from olaparib in BTC. OUTLINE: Patients receive olaparib orally (PO) twice daily (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 computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the trial, and collection of blood and tissue samples on study. After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 3 years.

Conditions

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

Interventions

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

Timeline

• Start date: 2020-06-24
• Primary completion: 2024-08-30
• Completion: 2025-03-30
• First posted: 2019-08-02
• Last updated: 2023-10-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study