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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00500006
Other study ID # 0457-009
Secondary ID 2007_509
Status Terminated
Phase Phase 1
First received July 10, 2007
Last updated January 29, 2015
Start date October 2007
Est. completion date November 2007

Study information

Verified date January 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
dasatinib
Oral dasatinib 70 mg b.i.d. tablets twice daily.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics, Safety, Tolerability 28 Days Yes
Secondary Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability 28 Days No
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