A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

NCT00482703 | Completed Phase 1 Results DMC

• 1 other identifier: CA180-138
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

Brief Summary

The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)

Conditions

Myeloid Leukemia, Chronic

Keywords

Imatinib resistant or intolerant chronic phase CML

Outcome Measures

Primary Outcomes (1)

• Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24

  Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).

  Week 24

Secondary Outcomes (12)

• Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment

  Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.

• Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24

  Week 24

• Time to Major Cytogenetic Response (MCyR)

  time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met

• Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics

  Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.

• Duration of MCyR

  from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death

Other Outcomes (3)

• Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)

  Months 0, 4, 8, 12, 16, 20, 24

• Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)

  Months 0, 4, 8, 12, 16, 20, 24

• Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)

  Months 0, 4, 8, 12, 16, 20, 24

Study Arms (2)

A

EXPERIMENTAL

Drug: Dasatinib

B

EXPERIMENTAL

Drug: dasatinib

Interventions

dasatinib DRUG

tablets, Oral, 100 mg, once daily

Also known as: Sprycel, BMS-354825

A

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to Imatinib mesylate or have intolerance of imatinib mesylate
• Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
• Men and women, ages 20 to 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

You may not qualify if:

• 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
• Adequate hepatic function
• Adequate renal function
• Medication that increases bleeding risk
• Medication that changes heart rhythms
• Subjects who are compulsory detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (9)

Local Institution

Nagoya, Aichi-ken, 464-8681, Japan

Location

Local Institution

Nishinomiya-Shi, Hyōgo, 663-8501, Japan

Location

Local Institution

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Local Institution

Isehara-Shi, Kanagawa, 259-1193, Japan

Location

Local Institution

Kyoto, Kyoto, Japan

Location

Local Institution

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution

Bunkyo-Ku, Tokyo, 113-8677, Japan

Location

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Local Institution

Shibuya-Ku, Tokyo, 150-8935, Japan

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 17, 2010
• Results First Posted: November 30, 2010

Record last verified: 2010-11

Locations

JP (9)