A Phase I Dose Escalation Combination Study in Patients With Chronic Myelogenous Leukemia (CML) and Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)(0457-009)(TERMINATED)
This study has been terminated.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00500006
First received: July 10, 2007
Last updated: March 21, 2013
Last verified: March 2013
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Purpose
This study will evaluate MK0457 in combination with Dasatinib in patients with Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Efficacy and Safety will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia Leukemia, Lymphoblastic, Acute, Philadelphia-Positive |
Drug: MK0457 Drug: dasatinib |
Phase 1 |
| 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 Dose Escalation of MK0457 in Combination With Dasatinib in Patients With Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
tetrasomy 18p
Drug Information available for:
Dasatinib
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Pharmacokinetics, Safety, Tolerability [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | October 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A
Arm A: Drug and comparator
|
Drug: MK0457
Schedule A: 5-day continuous IV infusion every 28 days MK0457 (dose determined by height and weight). Starting dose = 20 mg/m2/hour titrating up to 33 mg/m2/hour. Schedule B: 6-hr IV infusion every 14 days MK0457 (dose determined by height and weight). Starting dose = 64 mg/m2/hour titrating up to 216 mg/m2/hour. Oral dasatinib 70 mg b.i.d. tablets twice daily.
Other Name: Sprycel®
|
|
B
Arm B: Drug and comparator
|
Drug: MK0457
Schedule A: 5-day continuous IV infusion every 28 days MK0457 (dose determined by height and weight). Starting dose = 20 mg/m2/hour titrating up to 33 mg/m2/hour. Schedule B: 6-hr IV infusion every 14 days MK0457 (dose determined by height and weight). Starting dose = 64 mg/m2/hour titrating up to 216 mg/m2/hour. Oral dasatinib 70 mg b.i.d. tablets twice daily.
Other Name: Sprycel®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
- Patients must be at least 3 months from the start of dasatinib therapy and are currently receiving dasatinib therapy for CML or Ph+ ALL and be evaluable for hematologic response prior to entering the study
- Patient is able to be treated with a 70 mg bid dose of dasatinib without significant toxicity at the time of study entry
- Patients with active CNS disease are included and may be treated concurrently with intrathecal therapy as per institutional standards
Exclusion Criteria:
- Patient has had treatment with any anti-leukemia therapy (investigational or approved) other than dasatinib during the preceding 3 months. Pheresis or hydroxyurea treatment in the preceding 3 months will not exclude patients from eligibility
- Patient has unresolved more than or equal to grade 2 clinically significant toxicity attributed to dasatinib at the time of study entry
- Patient has known hypersensitivity to the components of study drug or its analogs
- Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
- Patient has symptomatic ascites, pericardial or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible
- Patient has had prior radiation therapy to more than 10% of the bone marrow; patients must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy
- Patient has a LVEF <40% by multigated radionucleotide angiography (MUGA) or echocardiography
Contacts and Locations More Information
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00500006 History of Changes |
| Other Study ID Numbers: | 2007_509, MK0457-009 |
| Study First Received: | July 10, 2007 |
| Last Updated: | March 21, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013