NCT04042831

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

Status unknown Phase 2 Last updated 13 October 2023

What this trial tests

Phase 2 trial testing Biospecimen Collection in Bile Duct Adenocarcinoma in 36 participants. Status unknown.

Timeline

24 June 2020

Primary endpoint
30 August 2024

30 March 2025

Quick facts

Lead sponsor	Academic and Community Cancer Research United
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	24 June 2020
Primary completion	30 August 2024
Estimated completion	30 March 2025
Sites	6 locations across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Computed Tomography
• Magnetic Resonance Imaging
• Olaparib (olaparib) — full drug profile →

Conditions studied

• Bile Duct Adenocarcinoma — all drugs for Bile Duct Adenocarcinoma →
• Fanconi Anemia Complementation Group Gene Mutation — all drugs for Fanconi Anemia Complementation Group Gene Mutation →
• Metastatic Bile Duct Carcinoma — all drugs for Metastatic Bile Duct Carcinoma →
• PTEN Gene Deletion — all drugs for PTEN Gene Deletion →

Sponsor

Academic and Community Cancer Research United — full company profile →

Who can join

18 and older, any sex, with Bile Duct Adenocarcinoma or Fanconi Anemia Complementation Group Gene Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The SWI/SNF complex in cancer - biology, biomarkers and therapy.
   Mittal P, Roberts CWM. · · 2020 · cited 537× · PMID 32303701 · DOI 10.1038/s41571-020-0357-3
2. Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
   Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
3. Therapy of Primary Liver Cancer.
   Feng M, Pan Y, Kong R, Shu S. · · 2020 · cited 71× · PMID 32914142 · DOI 10.1016/j.xinn.2020.100032
4. Treating ARID1A mutated cancers by harnessing synthetic lethality and DNA damage response.
   Mandal J, Mandal P, Wang TL, Shih IM. · · 2022 · cited 68× · PMID 36123603 · DOI 10.1186/s12929-022-00856-5
5. New and Emerging Systemic Therapeutic Options for Advanced Cholangiocarcinoma.
   Massironi S, Pilla L, Elvevi A, Longarini R, et al · · 2020 · cited 63× · PMID 32168869 · DOI 10.3390/cells9030688
6. Rational development of combination therapies for biliary tract cancers.
   Harding JJ, Khalil DN, Fabris L, Abou-Alfa GK. · · 2023 · cited 53× · PMID 36150578 · DOI 10.1016/j.jhep.2022.09.004
7. DNA Repair Gene Mutations as Predictors of Immune Checkpoint Inhibitor Response beyond Tumor Mutation Burden.
   Hsiehchen D, Hsieh A, Samstein RM, Lu T, et al · · 2020 · cited 50× · PMID 32676589 · DOI 10.1016/j.xcrm.2020.100034
8. Targeted Therapies in Advanced Biliary Tract Cancer: An Evolving Paradigm.
   Chakrabarti S, Kamgar M, Mahipal A. · · 2020 · cited 48× · PMID 32722188 · DOI 10.3390/cancers12082039