Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (START rollover)

December 16, 2015 updated by: Bristol-Myers Squibb

Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1021
        • Local Institution
      • Buenos Aires, Argentina, 1280
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1425
        • Local Institution
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
  • Belgium
      • Mont-godinne, Belgium, 5530
        • Local Institution
  • Brazil
      • Rio de Janeiro, Brazil, 20231
        • Local Institution
      • Sao Paulo, Brazil, 05403
        • Local Institution
      • Sao Paulo, Brazil, 05652
        • Local Institution
    • Parana
      • Curitiba, Parana, Brazil, 80060
        • Local Institution
    • San Paulo
      • Campinas, San Paulo, Brazil, 13083
        • Local Institution
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4X 1K9
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Local Institution
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution
  • France
      • Lille, France, 59000
        • Local Institution
      • Lyon Cedex 03, France, 69437
        • Local Institution
      • Nantes, France, 44035
        • Local Institution
      • Paris, France, 75475
        • Local Institution
      • Pessac, France, 33604
        • Local Institution
      • Poitiers Cedex, France, 86021
        • Local Institution
      • Strasbourg, France, 67091
        • Local Institution
  • Germany
      • Hamburg, Germany, 20246
        • Local Institution
      • Leipzig, Germany, 04103
        • Local Institution
      • Mannheim, Germany, 68167
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1097
        • Local Institution
  • Ireland
    • Dublin
      • Dublin 8, Dublin, Ireland
        • Local Institution
  • Israel
      • Ramat-gan, Israel, 52621
        • Local Institution
  • Italy
      • Bologna, Italy, 40138
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Orbassano (to), Italy, 10043
        • Local Institution
      • Roma, Italy, 00144
        • Local Institution
  • Korea, Republic of
      • Jeollanam-do, Korea, Republic of, 519-809
        • Local Institution
      • Seoul, Korea, Republic of, 137-040
        • Local Institution
  • Norway
      • Trondheim, Norway, 7006
        • Local Institution
  • Peru
      • Lima, Peru, 34
        • Local Institution
      • Lima, Peru, LIMA II
        • Local Institution
  • Poland
      • Katowice, Poland, 40032
        • Local Institution
      • Krakow, Poland, 31501
        • Local Institution
      • Lodz, Poland, 93-510
        • Local Institution
      • Lublin, Poland, 20081
        • Local Institution
      • Warsaw, Poland, 02097
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 125167
        • Local Institution
      • St.petersburg, Russian Federation, 179089
        • Local Institution
  • South Africa
    • Gauteng
      • Groenkloof, Gauteng, South Africa, 0181
        • Local Institution
      • Parktown, Gauteng, South Africa, 2193
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
  • Sweden
      • Gothenburg, Sweden, 41345
        • Local Institution
      • Lund, Sweden, 221 85
        • Local Institution
      • Stockholm, Sweden, SE-17176
        • Local Institution
      • Umea, Sweden, 901 85
        • Local Institution
      • Uppsala, Sweden, 751 85
        • Local Institution
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution
  • Thailand
      • Bangkok, Thailand, 10400
        • Local Institution
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, W12 OHS
        • Local Institution
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 OXB
        • Local Institution
    • Tyne And Wear
      • Newcastle, Tyne And Wear, United Kingdom, NE2 4HH
        • Local Institution
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center Inc
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Department of Medicine
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Central Indiana Cancer Centers
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Faber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sci Univ
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria

  • Signed written informed consent
  • Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
  • Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
  • Men and women, ages 18 and older

Key Exclusion Criteria

  • A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
  • Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dasatinib, 50 mg QD to 120 mg BID, Chronic phase
Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID).
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase
Other: Imatinib, 400 mg BID, Chronic phase
Participants with chronic phase disease received 400 mg of imatinib twice BID.
Drug: Imatinib
Imatinib was supplied as 100- and 400-mg tablets.
Other Names:
  • Gleevec/Glivec
Other: Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP
Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase
Other: Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP
Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase
Other: Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
Time Frame: Day 1 of treatment through a maximum of 82 months + 30 days
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.
Day 1 of treatment through a maximum of 82 months + 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-188
  • 2007-003624-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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