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

Wake Forest University (WFU)

Status and phase

Completed

Phase 1

Conditions

Advanced Hematologic Malignancies

Treatments

Drug: CPI-613

Study type

Interventional

Funder types

Other

Identifiers

NCT01034475

IRB00012124

CCCWFU 29109 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.