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

Who is this study for? Adult patients with Aberrant DNA Repair Gene Mutations
What treatments are being studied? Olaparib
Status: Unknown
Location: See all (6) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>= 18 years

• Histological or cytological documentation of metastatic adenocarcinoma of the biliary tract

• Patients with previously identified genetic aberrations that are associated with homologous recombinant repair pathway will be eligible \[e.g. somatic mutations in ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A\] or germline mutations in the above genes. Clinical Laboratory Improvement Act (CLIA)-certified assays including commercial tests (Foundation Medicine, Caris, Tempus) will be allowed

• Measurable disease

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2. (Form is available on the Academic and Community Cancer Research United \[ACCRU\] website)

• Life expectancy of \>= 16 weeks per estimation of investigator

• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 7 days prior to registration)

• Platelet count \>= 75,000/mm\^3 (obtained =\< 7 days prior to registration)

• Hemoglobin \>= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =\< 7 days prior to registration)

• Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 7 days prior to registration)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer) (obtained =\< 7 days prior to registration)

• Serum creatinine =\< 1.5 x ULN (obtained =\< 7 days prior to registration)

• Institutional normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 7 days prior to registration)

⁃ Exception: Patients who are therapeutically treated with anticoagulant agents will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care

• Alkaline phosphatase limit =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement of their cancer) (obtained =\< 7 days prior to registration)

• Creatinine clearance estimated of \>= 51 mL/min using the Cockcroft-Gault equation (obtained =\< 7 days prior to registration)

• Negative serum pregnancy test done =\< 28 days prior to registration and confirmed prior to treatment on day 1, for women of childbearing potential, postmenopausal women or women of childbearing potential with evidence of non-childbearing status.

⁃ Postmenopausal is defined as:

∙ Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments

‣ Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50

‣ Radiation-induced oophorectomy with last menses \> 1 year ago

‣ Chemotherapy-induced menopause with \> 1 year interval since last menses

‣ Surgical sterilization (bilateral oophorectomy or hysterectomy)

• Provide informed written consent

• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

• Willing to provide blood and tissue for correlative purposes

• Hepatitis B virus surface antigen (HBsAg), anti-hepatitis B virus core antigen (anti-HBc) and hepatitis B virus surface antigen (anti-HBs)

• Patients with chronic HBV receiving any systemic anticancer therapy should receive antiviral prophylactic therapy through and for minimum 12 months following anticancer therapy

• Patients with past HBV undergoing other systemic anticancer therapies not clearly associated with a high risk of HBV reactivation should be monitored with HBsAg and alanine aminotransferase during cancer treatment (suggest every other cycle)

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
COMPLETED
Jacksonville
Massachusetts
Dana-Farber Cancer Institute
WITHDRAWN
Boston
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Time Frame
Start Date: 2020-06-24
Completion Date: 2025-03-30
Participants
Target number of participants: 36
Treatments
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. Patients also undergo CT scan or MRI throughout the trial, and collection of blood and tissue samples on study.
Related Therapeutic Areas
Sponsors
Leads: Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials