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
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| ClinicalTrials.gov Identifier: NCT01034475 |
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Recruitment Status
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Completed
First Posted
: December 17, 2009
Last Update Posted
: May 30, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Hematologic Malignancies | Drug: CPI-613 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 26 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | March 2010 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | August 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: CPI-613
CPI-240 mg/m2
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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. |
- To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks. [ Time Frame: 3 weeks ]
- To determine PKs of CPI-613 following IV administration. [ Time Frame: 3 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034475
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27012 | |
Publications of Results:
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01034475 History of Changes |
| Other Study ID Numbers: |
CCCWFU 29109 |
| First Posted: | December 17, 2009 Key Record Dates |
| Last Update Posted: | May 30, 2017 |
| Last Verified: | September 2014 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Wake Forest University Health Sciences:
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acute myeloid leukemia acute lymphoblastic leukemia multiple myeloma chronic myeloid\ leukemia in blast phase |
Additional relevant MeSH terms:
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Neoplasms |