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
Overview
- Phase
- Phase 1
- Intervention
- CPI-613
- Conditions
- Advanced Hematologic Malignancies
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
CPI-613
CPI-240 mg/m2
Intervention: CPI-613
Outcomes
Primary Outcomes
To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
Time Frame: 3 weeks
Secondary Outcomes
- To determine PKs of CPI-613 following IV administration.(3 weeks)