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Sponsored by: |
Kyowa Hakko Kirin Pharma, Inc. |
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Information provided by: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00779480 |
To determine the maximum tolerated dose of KW-2449 in people with acute myelogenous leukemia who are not candidates for approved therapy. As well, the study will determine the response rate to KW-2449.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia (AML) |
Drug: KW-2449 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia |
Estimated Enrollment: | 60 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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KW-2449: Experimental
Sequential dose escalation in separate cohorts of 3+3 design from 450 mg/day to 800 mg/day total daily dose.
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Drug: KW-2449
KW-2449 50 mg capsules administered 3 or 4 times per day for 21-day cycles up to 6 cycles
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Phase 1: To determine the maximum tolerated daily dose (MTDD) of KW 2449 when administered to subjects with AML who are not candidates for approved therapy.
Phase 2: To determine the response rate to the dose and dosing regimen of KW-2449 selected in Phase 1 of the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed diagnosis of AML (excluding acute promyelocytic leukemia) that has relapsed or was not responsive to prior chemotherapy.
Phase 2: Only subjects with the FLT3/ITD mutation will be enrolled in Phase 2.
Exclusion Criteria:
Contact: David Bini | 609-919-1100 | bini.david@kyowa-kpi.com |
Contact: Niranjan Rao, PhD | 609-919-1100 | rao.niranjan@kyowa-kpi.com |
United States, Maryland | |
Baltimore, Maryland, United States | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States |
Responsible Party: | Kyowa Pharmaceutical, Inc. ( Terry F. Plasse, M.D., Medical Monitor ) |
Study ID Numbers: | 2449-US-002 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00779480 |
Health Authority: | United States: Food and Drug Administration |
Acute Myelogenous Leukemia Safety Dose Tolerance Pharmacokinetics/Pharmacodynamics FLT-3 |
Leukemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |