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

Phase 1

Completed

• Conditions: Advanced Hematologic Malignancies
• Interventions: Drug: CPI-613

• Registration Number: NCT01034475
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Study Start: 2010-03
• Primary Completion: 2013-06
• Study Completion: 2014-08
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• histologically or cytologically documented relapsed and/or refractory hematologic malignancy
• Karnofsky Performance Status (KPS) of >70%.
• Must be ≥18 years of age.
• Expected survival >1 month.
• Women of child-bearing potential must use accepted contraceptive methods
• No radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy within the 3 weeks prior to treatment with CPI-613.

Exclusion Criteria

• Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity.
• Patients with active central nervous system (CNS) or epidural tumor.
• Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
• Pregnant women, or women of child-bearing potential not using reliable means of contraception.
• Lactating females because the potential of excretion of CPI-613 into breast milk.
• Life expectancy less than 1 month.
• Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPI-613	CPI-613	CPI-240 mg/m2

Primary Outcome Measures

Name	Time	Method
To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.	3 weeks

Secondary Outcome Measures

Name	Time	Method
To determine PKs of CPI-613 following IV administration.	3 weeks

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States