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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

Primary Purpose

Advanced Hematologic Malignancies

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CPI-613

About this trial

This is an interventional treatment trial for Advanced Hematologic Malignancies focused on measuring acute myeloid leukemia, acute lymphoblastic leukemia, multiple myeloma, chronic myeloid\ leukemia in blast phase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPI-613

Arm Description

CPI-240 mg/m2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine PKs of CPI-613 following IV administration.

Full Information

NCT ID

NCT01034475

First Posted

December 16, 2009

Last Updated

June 29, 2018

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01034475

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hematologic Malignancies

Keywords

acute myeloid leukemia, acute lymphoblastic leukemia, multiple myeloma, chronic myeloid\ leukemia in blast phase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPI-613

Arm Type

Experimental

Arm Description

CPI-240 mg/m2

Intervention Type

Drug

Intervention Name(s)

CPI-613

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

To determine PKs of CPI-613 following IV administration.

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27012

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25165100

Citation

Pardee TS, Lee K, Luddy J, Maturo C, Rodriguez R, Isom S, Miller LD, Stadelman KM, Levitan D, Hurd D, Ellis LR, Harrelson R, Manuel M, Dralle S, Lyerly S, Powell BL. A phase I study of the first-in-class antimitochondrial metabolism agent, CPI-613, in patients with advanced hematologic malignancies. Clin Cancer Res. 2014 Oct 15;20(20):5255-64. doi: 10.1158/1078-0432.CCR-14-1019. Epub 2014 Aug 27.

Results Reference

result

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