Expired Study
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Los Angeles, California 90095


RATIONALE: PKC412 and itraconazole may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I/II trial to study the effectiveness of PKC412 with or without itraconazole in treating patients who have acute myeloid leukemia or myelodysplastic syndrome.

Study summary:

OBJECTIVES: Primary - Determine the safety, tolerability, and pharmacokinetics of PKC412 with or without itraconazole in patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. - Determine the pharmacodynamic activity of PKC412 on functional FLT3 inhibition in the cells of these patients. Secondary - Determine the pharmacokinetics and total blood concentration of PKC412 and its metabolites in these patients. - Determine the biological and preliminary antitumor activity of these regimens in these patients. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to FLT3 status (wild type vs mutated). Patients are assigned to 1 of 2 treatment groups. - Group I: Patients receive oral PKC412 twice daily on days 1-28. - Group II: Patients receive PKC412 as in group I. Patients also receive oral itraconazole twice daily on days 22-28. In both groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 24 patients (12 per treatment group) will be accrued for this study.


DISEASE CHARACTERISTICS: - One of the following diagnoses: - Acute myeloid leukemia, meeting 1 of the following criteria: - Ineligible for myelosuppressive chemotherapy - Relapsed or refractory disease after standard therapy and not likely to require cytoreductive therapy within 1 month - Myelodysplastic syndromes of 1 the following types: - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - Documented wild type or mutated FLT3 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - SGOT or SGPT ≤ 3 times upper limit of normal (ULN) - Bilirubin ≤ 2 times ULN Renal - Creatinine ≤ 1.5 times ULN Pulmonary - No pulmonary infiltrate on baseline chest x-ray that is known to be new within the past 4 weeks Gastrointestinal - No gastrointestinal function impairment - No gastrointestinal disease that would significantly alter the absorption of study drug Other - No uncontrolled active infection - No other concurrent severe and/or uncontrolled medical or psychiatric condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 2 months since prior allogeneic, syngeneic, or autologous bone marrow or stem cell transplantation Chemotherapy - See Disease Characteristics - Recovered from prior cytotoxic chemotherapy - At least 1 week since prior hydroxyurea Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 4 weeks since prior anticancer therapy - No more than 2 prior regimens for primary refractory or relapsed disease - No prior FLT3 inhibitor therapy - No other concurrent anticancer therapy



Primary Contact:

Study Chair
Virginia Klimek, MD
Memorial Sloan-Kettering Cancer Center

Backup Contact:


Location Contact:

Los Angeles, California 90095
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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