Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT02420795) | Clinical Trial Compass
TerminatedPhase 1/2
Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Stopped: Per PI Request
United States16 participantsStarted 2015-11-03
Plain-language summary
This phase I/II trial studies the side effects and the best dose of v-akt murine thymoma viral oncogene homolog (Akt)/mitogen-activated protein kinase 1(ERK) inhibitor ONC201 and to see how well it works in treating patients with non-Hodgkin's lymphoma that has returned after a period of improvement or does not respond to treatment. Akt/ERK inhibitor ONC201 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Phase 1 and Phase 2: confirmed diagnosis of previously treated relapsed and/or refractory lymphoma; patients with central nervous system (CNS) lymphoma are included
* Patient with leukemia phase (peripheral blood involvement), CNS lymphoma \[including cerebrospinal fluid (CSF)-only disease\], non-measurable disease, gastrointestinal (GI) mantle cell lymphoma (MCL), or bone marrow (BM) MCL are also eligible; gastrointestinal or bone marrow or spleen only patients are allowable and will be analyzed separately
* All adverse events related to prior therapies (chemotherapy, radiotherapy, and/or surgery) must be resolved to =\< grade 1, except for alopecia
* Patients must be willing to receive transfusions of blood products
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
* Serum creatinine \< 2.0 mg/dl
* Serum bilirubin \< 1.5 mg/dl
* Platelet count \> 50,000/mm\^3
* Absolute neutrophil count (ANC) \> 1,000/mm\^3
* Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \< 2 x upper limit of normal or \< 5 x upper limit of normal if hepatic metastases are present
* Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 90 days after the last dose of study treatment; accept…
What they're measuring
1
Recommended Phase 2 Dose (RP2D) (Phase I)
Timeframe: 21 days
2
Number of Participants With Overall Response Rate (Phase 1 and 2)