Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractor… (NCT03925428) | Clinical Trial Compass
WithdrawnPhase 1
Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas
Stopped: Other - Protocol moved to Disapproved
0Started 2020-09-18
Plain-language summary
This phase I trial studies the side effects and best dose of GSK525762C (molibresib besylate) and entinostat in treating patients with solid tumors or lymphomas that have spread to other parts of the body (advanced) or are not responding to treatment (refractory). GSK525762C and entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study may help doctors find out if giving the combination of GSK525762C and entinostat is better or worse than the usual approach for treating solid tumors or lymphomas.
Who can participate
Age range12 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:
* Patients must have advanced or refractory solid tumor or lymphoma (all B cell lymphomas and T cell lymphomas other than natural killer \[NK\]-cell lymphoma).
* For patients in the dose expansion cohort:
* Cohort A: Patients must have locally advanced, unresectable OR metastatic pancreatic cancer refractory to standard therapy.
* Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
* Patients should have received previous therapy with at least one combination chemotherapy regimen for metastatic disease.
* Patients with lymphoma must have exhausted or refused potential curative therapy prior to enrolling.
* Weight of \>= 35 kg.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%).
* Hemoglobin \>= 9.0 g/dL (within 14 days prior to administration of study treatment).
* Absolute neutrophil count (ANC) \>= 1,500/mcL (within 14 days prior to administration of study treatment).
* Platelets \>= 100,000/mcL (within 14 days prior to administration of study treatment).
* Total bilirubin =\< institutional upper limit of normal (ULN) (within 14 days prior to administration of study treatment).
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (within 14 days prior to administration of study treatment).
* Serum creatinine clea…