Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene … (NCT04042831) | Clinical Trial Compass
UnknownPhase 2
Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
United States36 participantsStarted 2020-06-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 norm…
What they're measuring
1
Progression-free survival (PFS) at first scan
Timeframe: At first scan (approximately 8 weeks)
Trial details
NCT IDNCT04042831
SponsorAcademic and Community Cancer Research United