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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Comprehensive Cancer Center of Wake Forest University

ClinicalTrials.gov Identifier:

NCT01034475

First received: December 16, 2009

Last updated: November 13, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 16, 2009
Last Updated Date	November 13, 2012
Start Date ^ICMJE	March 2010
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 16, 2009)	To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01034475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 16, 2009)	To determine PKs of CPI-613 following IV administration. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Advanced Hematologic Malignancies
Intervention ^ICMJE	Drug: CPI-613 This is a Phase I open label trial using a 2-stage dose-escalation scheme (single-patient & traditional stages): Single-Patient Dose-Escalation Stage: In the single-patient stage, a single patient will be accrued per dose level. The starting dose will be 420 mg/m². Dose level will be escalated (by doubling the previous dose) if there is no toxicity or if the toxicity is grade 1 or less. If toxicity is >Grade 1, the traditional dose-escalation stage will be triggered. Traditional Dose-Escalation: All dose escalations conducted in this Traditional Dose-Escalation stage will be escalated according to the modified Fibonacci Dose-Escalation scheme.
Study Arm (s)	Experimental: CPI-613 CPI-240 mg/m2 Intervention: Drug: CPI-613
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	January 2014
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01034475
Other Study ID Numbers ^ICMJE	CCCWFU 29109
Has Data Monitoring Committee	Yes
Responsible Party	Comprehensive Cancer Center of Wake Forest University
Study Sponsor ^ICMJE	Comprehensive Cancer Center of Wake Forest University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Comprehensive Cancer Center of Wake Forest University
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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