Study design and patients
NCT01303341, tumor, Cancer
ONCOLOGY, TUMOR, SOLID TUMORS, CANCER
This was an open label phase I dose escalation trial conducted at Rutgers Cancer Institute of New Jersey (NCT01303341, NCI-CTEP #8850). Eligible patients were ≥18 years with solid tumors refractory to standard therapy or for whom no standard therapy existed, with a planned expansion cohort in patients with mandatory paired tumor biopsies for correlative studies at the recommended safe dose of the combination. There were no restrictions on the number of prior therapies; however, patients enrolled into the expansion cohort were excluded if they had prior therapy with riluzole or sorafenib. Other key inclusion criteria included an Eastern Cooperative Oncology Group (ECOG) performance status ≤2, clinically stable brain lesions for at least 4 weeks, adequate hematological function (ANC ≥1,500/μL, platelets ≥100,000 μL), adequate hepatic function (total bilirubin ≤1.5 X institutional ULM, AST(SGOT)/SLT(SGPT) ≤2.5 X institutional ULN), INR ≤1.5 institutional ULN, and adequate renal function (creatinine ≤2X ULN). The study protocol was approved by the Rutgers Robert Wood Johnson Medical School Institutional Review Board (NCT01303341) and written informed consent was obtained from all patients.