Rollover Study of BMS-354825 in Patients With CML and Ph+ALL

NCT01030718 | Completed Phase 1 Results DMC

• 1 other identifier: CA180-036
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)

Conditions

Chronic Myelogenous Leukemia; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation

  AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.

  baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation

Secondary Outcomes (23)

• Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response

  At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)

• Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response

  At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter

• Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response

  At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter

• Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)

  At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),

• Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)

  At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter

Study Arms (3)

dasatinib (CML-CP)

EXPERIMENTAL

CML - Chronic Phase

Drug: dasatinib

dasatinib (CML-AP/BP)

EXPERIMENTAL

CML - Accelerated Phase and Blast Phase

Drug: dasatinib

dasatinib (Ph+ ALL)

EXPERIMENTAL

Ph+ Acute Lymphoblastic Leukemia

Drug: dasatinib

Interventions

dasatinib DRUG

Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID

Also known as: Sprycel, BMS-354825

dasatinib (CML-AP/BP); dasatinib (CML-CP); dasatinib (Ph+ ALL)

Eligibility Criteria

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

You may qualify if:

• Subjects who were eligible and completed the previous Phase I and II study (CA180031/NCT00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject

You may not qualify if:

• Women who are pregnant or breastfeeding
• Subjects who are eligible and willing to undergo transplantation at pre-study
• Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II study (CA180031/NCT00337454)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

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

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: January 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 14, 2010
• Results First Posted: December 14, 2010

Record last verified: 2010-11