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
Status: | Completed |
---|---|
Conditions: | Cancer, Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/4/2018 |
Start Date: | March 2010 |
End Date: | August 2014 |
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
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.
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.
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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
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