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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00982488




Registration number
NCT00982488
Ethics application status
Date submitted
16/09/2009
Date registered
23/09/2009
Date last updated
22/01/2016

Titles & IDs
Public title
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Scientific 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
Secondary ID [1] 0 0
2007-003624-37
Secondary ID [2] 0 0
CA180-188
Universal Trial Number (UTN)
Trial acronym
START rollover
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Treatment: Drugs - Imatinib

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).

Other: Imatinib, 400 mg BID, Chronic phase - Participants with chronic phase disease received 400 mg of imatinib twice BID.

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.

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.

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.


Treatment: Drugs: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.

Treatment: Drugs: Imatinib
Imatinib was supplied as 100- and 400-mg tablets.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 of treatment through a maximum of 82 months + 30 days

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Local Institution - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
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United States of America
State/province [6] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
State/province [8] 0 0
New Jersey
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United States of America
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Oregon
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United States of America
State/province [10] 0 0
Pennsylvania
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United States of America
State/province [11] 0 0
Texas
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Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Belgium
State/province [13] 0 0
Mont-godinne
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Brazil
State/province [14] 0 0
Parana
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Brazil
State/province [15] 0 0
San Paulo
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Helsinki
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France
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Lille
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France
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Lyon Cedex 03
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France
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Nantes
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France
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Paris
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France
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Pessac
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France
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Poitiers Cedex
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France
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Strasbourg
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Germany
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Hamburg
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Germany
State/province [29] 0 0
Leipzig
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Germany
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Mannheim
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Hungary
State/province [31] 0 0
Budapest
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Ireland
State/province [32] 0 0
Dublin
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Israel
State/province [33] 0 0
Ramat-gan
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Italy
State/province [34] 0 0
Bologna
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Italy
State/province [35] 0 0
Napoli
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Italy
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Orbassano (to)
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Italy
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Roma
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Seoul
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Norway
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Trondheim
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Peru
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Lima
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Warsaw
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Russian Federation
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Moscow
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Russian Federation
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St.petersburg
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South Africa
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Gauteng
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Spain
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Barcelona
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Sweden
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Gothenburg
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Switzerland
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Basel
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Thailand
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Bangkok
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United Kingdom
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Greater London
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United Kingdom
State/province [59] 0 0
Scotland
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Tyne And Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00982488
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications