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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Hematologic Malignancies

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 29109

NCT ID:

NCT01034475

Start Date:

March 2010

Completion Date:

January 2014

Related Keywords:

  • Advanced Hematologic Malignancies
  • acute myeloid leukemia
  • acute lymphoblastic leukemia
  • multiple myeloma
  • chronic myeloid\ leukemia in blast phase
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157