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 Cancer Patients
Abstract
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 cancer patients
The objectives of this study are:
* To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
* To determine pharmacokinetics of CPI-613 following intravenous (IV) administration.
* To observe the anti-tumor effects of CPI-613, if any occur.
Conditions: Advanced Cancer, Metastatic Cancer, Lymphoma, Solid Tumors, Advanced Malignancies.
Primary outcome: To evaluate the safety, tolerability, maximum tolerated dose (MTD), and efficacy pharmacokinetics of CPI-613 given twice weekly for three consecutive weeks in cancer patients.
Enrollment: 39 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 39 participants or records.
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