Advanced Hematologic Malignancies Clinical Trial
Official title:
An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Patients With Advanced Hematologic Malignancies
Chemotherapy resistance is a major cause of death in patients with advanced hematologic
malignancies. The proposed novel mechanism of action, non-cross resistance with
chemotherapeutic agents currently used in the clinic, and lack of CPI-613-related
myelosuppression preclinically and clinically to date make CPI-613 a suitable candidate for
phase I clinical trial in these patients. The current trial is one of several clinical trials
of CPI-613. Other clinical trials that are conducted in patients with solid tumors have
already been initiated.
The primary objective of this study is to determine the safety and MTD of CPI-613 when
administered 2x weekly for 3 consecutive weeks.
The secondary objective is to determine the PKs of CPI-613 following IV administration and to
observe the anti-tumor effects of CPI-613, if any occur.
n/a
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