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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: | NCT00346632 |
Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia |
Drug: KW-2449 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of KW-2449 in Acute Leukemias (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelogenous Leukemia (CML) |
Enrollment: | 37 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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KW-2449: Experimental
Treatment with ascending doses of KW-2449
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Drug: KW-2449
Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).
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This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute leukemias, high risk MDS, and CML who are not candidates for approved therapy. Over an 18-month period, the investigative sites collectively will enroll up to a total of 96 subjects. Subjects will be enrolled sequentially into 1 of 7 dose groups to evaluate 2 dosing schedules (Arm A = 14 consecutive days of dosing followed by a 7-28 day rest period as determined by recovery from any acute hematologic and non-hematologic toxicities, or Arm B = 28 consecutive days of dosing followed by a 7-28 day rest period, as determined by recovery from any acute hematologic and non-hematologic toxicities). The safety of a dose level in Arm A (14-day dosing regimen) will be established prior to enrollment of subjects in the same dose level in Arm B (28-day dosing regimen).
In April 2007 the protocol was amended to discontinue Arm B (28 consecutive days of dosing). The protocol will continue as planned for Arm A (14 days of consecutive dosing).
Enrollment will proceed until a maximum tolerated dose (MTD) has been established for each study Arm. Once the MTD has been reached, 12 additional subjects, with 1 or more of the hematologic conditions included in this study, may be enrolled at the MTD as an expanded safety cohort.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed diagnosis of:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, New Jersey | |
Contact Kyowa | |
Princeton, New Jersey, United States, 08540 | |
United States, New York | |
Weill Cornell/New York Presbyterian Hospital | |
New York, New York, United States, 10021 | |
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Director: | Matt Fujimori, MD | Kyowa Hakko Kirin Pharma, Inc. |
Responsible Party: | Kyowa Pharmaceutical, Inc. ( Allyson Pollack ) |
Study ID Numbers: | 2449-US-001 |
Study First Received: | June 28, 2006 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00346632 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AML ALL MDS CML Kinase Inhibitor |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia |
Lymphatic Diseases Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
Leukemia, Lymphoid Disease Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Precancerous Conditions Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid |
Leukemia, Myeloid, Acute Leukemia Lymphatic Diseases Preleukemia Neoplasms Pathologic Processes Syndrome Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders |