Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or … (NCT03257761) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer
United States55 participantsStarted 2018-02-07
Plain-language summary
This phase Ib trial studies the side effects and best dose of guadecitabine and how well it works when given together with durvalumab in treating patients with liver, pancreatic, bile duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as durvalumab, may block tumor growth in different ways by targeting certain cells. Giving guadecitabine and durvalumab may work better in treating patients with liver, pancreatic, bile duct, or gallbladder cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\> 1500 per mm\^3) except for patients with HCC for whom ANC \>= 1000 per mm\^3 is allowed
* Platelet count \>= 100 x 10\^9/L (\> 100,000 per mm\^3), except for patients with HCC for whom a platelet count \> 60,000 per mm\^3 is allowed
* Hemoglobin \>= 8.0 g/dL; if patients have a hemoglobin level below 8, blood transfusion is allowed to meet the eligibility criteria as long as post transfusion hemoglobin is maintained at \>= 8.0 g/dL for 7 days or longer
* Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x institutional upper limit of normal unless liver metastases are present or unless patient is known to have chronic liver disease (hepatitis) in which case AST and ALT must be =\< 5 x institutional upper limit of normal (IULN)
* Serum bilirubin =\< 2.5 x institutional upper limit of normal (ULN)
* Serum albumin \>= 2.5 g/dL
* Serum creatinine clearance (CL) \> 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days foll…