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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily focused on finding a safe dose and measuring side effects of combining guadecitabine and durvalumab, what is currently known about the safety profile of this combination for cancers like mine, and what kinds of adverse events have been reported so far?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — does that rule out any possibility of me participating, or are there related trials testing similar combinations of a hypomethylating agent and an immunotherapy checkpoint inhibitor that I might be eligible for?
3Given that my cancer type — whether it's pancreatic, bile duct, gallbladder, or liver — is included in this trial, how does the standard of care treatment for my specific diagnosis compare to an experimental combination like guadecitabine plus durvalumab, and would trying standard treatment first make more sense for my situation?
4Because durvalumab is an immunotherapy drug and guadecitabine affects DNA methylation, are there any features of my tumor — like specific biomarkers, mutation status, or immune markers — that would help you assess whether this type of combination approach is a reasonable direction for me to explore?
5What would the treatment schedule and monitoring demands of a trial like this look like in practice, and how might that fit with my current health status and day-to-day life while managing an advanced cancer diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.