Back to resultsLong-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (START rollover)
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia
Eligibility Criteria
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)
Sites / Locations
- Pacific Cancer Medical Center Inc
- Loma Linda University Cancer Center
- Ucla Department Of Medicine
- Stanford University School Of Medicine
- Kaiser Permanente Medical Center
- H. Lee Moffitt Cancer Center & Research Institute
- University Of Chicago
- Central Indiana Cancer Centers
- University Of Kansas Medical Center
- Dana Faber Cancer Institute
- University Of Michigan Medical Center
- Wayne State University
- John Theurer Cancer Center
- Oregon Health & Sci Univ
- Western Pennsylvania Hospital
- Ut Southwestern Medical Center At Dallas
- The University Of Texas Md Anderson Cancer Center
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Dasatinib, 50 mg QD to 120 mg BID, Chronic phase
Imatinib, 400 mg BID, Chronic phase
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL
Arm Description
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).
Participants with chronic phase disease received 400 mg of imatinib twice BID.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00982488
First Posted
September 16, 2009
Last Updated
December 16, 2015
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00982488
Brief Title
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Acronym
START rollover
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dasatinib, 50 mg QD to 120 mg BID, Chronic phase
Arm Type
Other
Arm Description
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).
Arm Title
Imatinib, 400 mg BID, Chronic phase
Arm Type
Other
Arm Description
Participants with chronic phase disease received 400 mg of imatinib twice BID.
Arm Title
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP
Arm Type
Other
Arm Description
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.
Arm Title
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP
Arm Type
Other
Arm Description
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.
Arm Title
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
BMS-354825, Sprycel, Src Kinase
Intervention Description
Dasatinib was supplied as 20- and 50-mg tablets.
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec/Glivec
Intervention Description
Imatinib was supplied as 100- and 400-mg tablets.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 1 of treatment through a maximum of 82 months + 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Cancer Medical Center Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Ucla Department Of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University School Of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
University Of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Dana Faber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University Of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Oregon Health & Sci Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Ut Southwestern Medical Center At Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University Of Texas Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1021
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Mont-godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060
Country
Brazil
Facility Name
Local Institution
City
Campinas
State/Province
San Paulo
ZIP/Postal Code
13083
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
20231
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05403
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05652
Country
Brazil
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1K9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Local Institution
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Local Institution
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Local Institution
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Local Institution
City
Dublin 8
State/Province
Dublin
Country
Ireland
Facility Name
Local Institution
City
Ramat-gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Orbassano (to)
ZIP/Postal Code
10043
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution
City
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Local Institution
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
LIMA II
Country
Peru
Facility Name
Local Institution
City
Katowice
ZIP/Postal Code
40032
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31501
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20081
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02097
Country
Poland
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Local Institution
City
St.petersburg
ZIP/Postal Code
179089
Country
Russian Federation
Facility Name
Local Institution
City
Groenkloof
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Local Institution
City
Parktown
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Local Institution
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
Local Institution
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 OXB
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle
State/Province
Tyne And Wear
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
We'll reach out to this number within 24 hrs