Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
Clinicaltrials.gov identifier:
NCT04042831
Treatment
Treatment study for people diagnosed with metastatic biliary tract (bile duct) cancer and who have an inherited or tumor mutation in ATM, BRCA 1/2, BRIP1, CHEK2, RAD51C, RAD51D, PALB2, PTEN, NBN and others
Study Contact Information:
For additional information, please contact: Principal Investigator: Daniel H Ahn at Mayo Clinic in Arizona
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 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 repair gene mutations that give them a higher risk of certain cancers. may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Type of Study
This is an , single-group study.
All participants will receive the same treatment.
What the Study Entails
Participants will receive 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 .
Arizona
City: Scottsdale RECRUITING
Facility: Mayo Clinic in Arizona
Contact Info:
855-776-0015
Daniel H. Ahn, MD
Minnesota
City: Rochester RECRUITING
Facility: Mayo Clinic in Rochester
Contact Info:
[email protected]
855-776-0015
Amit Mahipal
New York
City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
[email protected]
646-888-5334
Ghassan K. Abou-Alfa
Texas
City: Houston RECRUITING
Facility: M D Anderson Cancer Center
Contact Info:
[email protected]
713-792-2841
Milind Javle
Men or women age 18 years or older can participate if they:
- Have cancer of the biliary (bile duct) tract
- Have somatic or mutations in any of the following genes: , ATR, , 1/2, RAD51, , , , FANC, , 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 including
- Are taking warfarin (drug therapy that prevents blood clots from forming or growing larger)