Study of CPI-200 in Patients With Advanced Tumors

Summary

Participation Requirements

Description

Primary Objectives: • To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors Secondary Objectives: To evaluate the pharmacokinetics (PK) of CPI-200 To evaluate clinical response and resolution of symptoms after CPI-200 treatment To characte...

Primary Objectives: • To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors Secondary Objectives: To evaluate the pharmacokinetics (PK) of CPI-200 To evaluate clinical response and resolution of symptoms after CPI-200 treatment To characterize adverse events of CPI-200 in patients with advanced cancers Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed by a conventional 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-200 within 21 days: All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding toxicities clearly related to disease progression or inter-current illness Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3 fatigue if lasting less than 7 days as determined by CTCAEv5 criteria Grade 3 thrombocytopenia in the presence of bleeding Grade 3 or greater febrile neutropenia Any hematologic or non-hematologic adverse events or abnormal laboratory value(s) related to CPI-200 that result(s) in permanent study discontinuation of study treatment

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