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)

NCT00500006 | Terminated Phase 1

• 2 other identifiers: 0457-0092007_509
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Myelogenous Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics, Safety, Tolerability

  28 Days

Secondary Outcomes (1)

• Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability

  28 Days

Study Arms (2)

A

OTHER

Arm A: Drug and comparator

Drug: MK0457; Drug: dasatinib

B

OTHER

Arm B: Drug and comparator

Drug: MK0457; Drug: dasatinib

Interventions

MK0457 DRUG

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.

A; B

dasatinib DRUG

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

Also known as: Sprycel®

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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.

  PMID: 20563869 RESULT

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

tozasertib; Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 30, 2015

Record last verified: 2015-01