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

About the Study

This study will look at how well the PARP inhibitor olaparib works in treating women or men who have been diagnosed with biliary tract (bile duct) cancer that has metastasized to other places in the body and who also have DNA repair gene mutations that give them a higher risk of certain cancers.  Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Type of Study

This is an open-label, single-group study. 

All participants will receive the same treatment. 

What the Study Entails

Participants will receive olaparib orally twice per day on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

Study Sites

• Arizona
  • Scottsdale: Mayo Clinic in Arizona
    Contact: Clinical Trials D. Referrals Office by phone:  855-776-0015 or by email.   
    Principal Investigator: Daniel H. Ahn        
• Minnesota
  • Rochester: Mayo Clinic in Rochester
    Contact: Clinical Trials Referrals Office by phone: 855-776-0015 or by email.
    Principal Investigator: Nguyen Tran        
• New York
  • New York City
    Memorial Sloan Kettering Cancer Center
    Contact: Amin Yaqubie by phone: 646-477-8675 or by email.     
    Principal Investigator: Park Wungki        
• Texas
  • Houston
    M D Anderson Cancer Center
    Contact: Charles Stava by phone: 713-792-2841 or by email.      
    Principal Investigator: Milind Javle   

Men or women age 18 years or older can participate if they:  

• Have metastatic cancer of the biliary (bile duct) tract
• Have somatic or germline mutations in any of the following genes: ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A
• Have life expectancy of >= 16 weeks
• Are willing to provide blood and tissue samples
• Have had prior exposure or completion of platinum-based chemotherapy

Patients will be excluded if they have:  

• Got worse on platinum-based chemotherapy regimen or =< 6 months of completion of platinum-based chemotherapy regimen
• Congestive heart failure
• Uncontrolled high blood pressure
• Recent blood clot event such as transient ischemic attacks (TIA), deep vein thrombosis (DVT), or pulmonary embolism
• Active hepatitis B or C
• Seizure disorder requiring medication
• Non-healing wound, ulcer, or bone fracture
• Renal failure requiring dialysis
• Lung disease
• Women who are pregnant or nursing     
• Severe concurrent disease
• Immunocompromised patients and patients with human immunodeficiency virus (HIV) unless there is no clinical evidence of an immunocompromised state
• Prior exposure to any PARP inhibitor including olaparib
• Are taking warfarin (drug therapy that prevents blood clots from forming or growing larger)