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)
NCT ID: NCT00500006
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2007-10-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Arm A: Drug and comparator
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.
dasatinib
Oral dasatinib 70 mg b.i.d. tablets twice daily.
B
Arm B: Drug and comparator
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.
dasatinib
Oral dasatinib 70 mg b.i.d. tablets twice daily.
Interventions
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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.
dasatinib
Oral dasatinib 70 mg b.i.d. tablets twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Okabe S, Tauchi T, Ohyashiki K. Efficacy of MK-0457 and in combination with vorinostat against Philadelphia chromosome positive acute lymphoblastic leukemia cells. Ann Hematol. 2010 Nov;89(11):1081-7. doi: 10.1007/s00277-010-0998-x. Epub 2010 Jun 20.
Other Identifiers
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2007_509
Identifier Type: -
Identifier Source: secondary_id
0457-009
Identifier Type: -
Identifier Source: org_study_id
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