Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337454
First received: June 14, 2006
Last updated: April 7, 2011
Last verified: April 2011
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Purpose
This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia |
Drug: Dasatinib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
Secondary Outcome Measures:
- Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
- response
| Estimated Enrollment: | 48 |
| Study Start Date: | July 2005 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A1 |
Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Name: Sprycel
|
| Experimental: A2 |
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Name: Sprycel
|
| Experimental: A3 |
Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Name: Sprycel
|
| Experimental: B1 |
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Name: Sprycel
|
| Experimental: B2 |
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Name: Sprycel
|
| Experimental: B3 |
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Name: Sprycel
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Philadelphia chromosome positive or bcr-abl gene positive
- Chronic Myelogenous Leukemia (CML)
- Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
- Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
- Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
- Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
- Men and women, ages 20 - 75
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
Exclusion Criteria:
- Subjects who are eligible and willing to undergo transplantation at pre-study
- Women who are pregnant or breastfeeding
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML or ALL
- Adequate hepatic function
- Adequate renal function
- Medication that increase bleeding risk
- Medication that change heart rhythms
- Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337454
Locations
| Japan | |
| Local Institution | |
| Nagoya, Aichi, Japan, 466-8550 | |
| Local Institution | |
| Nagoya, Aichi, Japan, 464-8681 | |
| Local Institution | |
| Nagoya-Shi, Aichi, Japan, 467-8602 | |
| Local Institution | |
| Maebashi, Gunma, Japan, 371-0821 | |
| Local Institution | |
| Nishinomiya-Shi, Hyogo, Japan, 663-8501 | |
| Local Institution | |
| Kagoshima-Shi, Kagoshima, Japan, 890-0064 | |
| Local Institution | |
| Isehara-Shi, Kanagawa, Japan, 259-1193 | |
| Local Institution | |
| Sendai, Miyagi, Japan | |
| Local Institution | |
| Nagasaki City, Nagasaki, Japan | |
| Local Institution | |
| Okayama-Shi, Okayama, Japan, 700-0082 | |
| Local Institution | |
| Moriguchi, Osaka, Japan, 570-8540 | |
| Local Institution | |
| Iruma-Gun, Saitama, Japan, 350-0495 | |
| Local Institution | |
| Hamamatsu-Shi, Shizuoka, Japan, 431-3192 | |
| Local Institution | |
| Bunkyo-Ku, Tokyo, Japan, 113-8677 | |
| Local Institution | |
| Chuo-Ku, Tokyo, Japan, 104-0045 | |
| Local Institution | |
| Shinjuku-Ku, Tokyo, Japan, 160-8582 | |
| Local Institution | |
| Shinjuku-Ku, Tokyo, Japan, 162-8666 | |
| Local Institution | |
| Kanagawa, Japan | |
| Local Institution | |
| Kyoto, Japan | |
| Local Institution | |
| Tochigi, Japan, 329-0498 | |
| Local Institution | |
| Tokyo, Japan | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00337454 History of Changes |
| Other Study ID Numbers: | CA180-031 |
| Study First Received: | June 14, 2006 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Bristol-Myers Squibb:
|
Imatinib resistant or intolerant CML Treatment resistant or intolerant Ph+ALL |
Additional relevant MeSH terms:
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders |
Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes Imatinib Dasatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013