Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04042831|
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|ARID1A Gene Mutation ATM Gene Mutation ATR Gene Mutation Bile Duct Adenocarcinoma BRCA1 Gene Mutation BRCA2 Gene Mutation BRIP1 Gene Mutation CHEK2 Gene Mutation EMSY Gene Mutation Fanconi Anemia Complementation Group Gene Mutation Metastatic Bile Duct Carcinoma MRE11 Gene Mutation NBN Gene Mutation PALB2 Gene Mutation PTEN Gene Deletion RAD51 Gene Mutation||Drug: Olaparib||Phase 2|
I. To determine the efficacy (objective response rate) of olaparib monotherapy in advanced biliary tract cancer (BTC) with mutations in deoxyribonucleic acid (DNA) repair genes.
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 assess the frequency and severity of adverse events in advanced biliary tract cancer patients 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.
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.
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.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Olaparib in Patients With Advanced Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations|
|Estimated Study Start Date :||January 30, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2023|
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.
- Best objective response rate [ Time Frame: Up to 24 weeks after registration ]Will be defined as the percentage of patients with advanced biliary cancer treated with olaparib with aberrant deoxyribonucleic acid (DNA) repair/homologous recombination repair (HRR) genes, among evaluable patients, who had a response =< 24 weeks of registration. Response is defined as either complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Overall survival (OS) [ Time Frame: From study entry to death from any cause, assessed up to 3 years ]OS will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported.
- Progression-free survival (PFS) [ Time Frame: From study entry to the first of either disease progression or death from any cause, assessed up to 3 years ]Disease progression will be determined based on RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported.
- Incidence of adverse events [ Time Frame: Up to 3 years ]Adverse events by patient will be summarized by frequencies and severity using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Duration of response (DoR) [ Time Frame: Up to 3 years ]Will be defined for all evaluable patients who have achieved an objective response as the date at which the patient?s earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented, or death if no prior evidence of disease progression. The distribution of DoR will be estimated using the method of Kaplan-Meier (Kaplan and Meier 1958).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042831
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|Contact: Peter D. Masci 480-342-6011 email@example.com|
|Principal Investigator: Daniel H. Ahn|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Contact: Norka C. Snyder 617-643-4971 firstname.lastname@example.org|
|Principal Investigator: Lipika Goyal|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: ACCRU Operations 507-538-7448 ACCRU@mayo.edu|
|Principal Investigator: Amit Mahipal|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Contact: Angemael Syldor 646-888-5334 email@example.com|
|Principal Investigator: Ghassan K. Abou-Alfa|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Charles Stava 713-792-2841 firstname.lastname@example.org|
|Principal Investigator: Milind Javle|
|Principal Investigator:||Daniel H Ahn||Academic and Community Cancer Research United|