Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Show all queries
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00101660
Registration number
NCT00101660
Ethics application status
Date submitted
12/01/2005
Date registered
13/01/2005
Date last updated
2/03/2012
Titles & IDs
Public title
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
Query!
Scientific title
A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib
Query!
Secondary ID [1]
0
0
CA180-013
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia
0
0
Query!
Philadelphia-Positive Myeloid Leukemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Experimental: Dasatinib, 70 mg twice daily (BID) - Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
Treatment: Drugs: Dasatinib
Tablets; oral; 70 mg BID, depending on response
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)
Query!
Assessment method [1]
0
0
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [1]
0
0
Number of Imatinib-intolerant Participants With MCyR
Query!
Assessment method [1]
0
0
Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Query!
Timepoint [1]
0
0
Baseline to 2 years
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Query!
Assessment method [2]
0
0
Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.
Query!
Timepoint [2]
0
0
12 and 24 Months
Query!
Secondary outcome [3]
0
0
Median Time From First Dosing Date to Date of MCyR
Query!
Assessment method [3]
0
0
MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Query!
Timepoint [3]
0
0
Baseline (within 4 weeks of Day 1) and every 12 weeks
Query!
Secondary outcome [4]
0
0
Number of Participants With Complete Hematologic Response (CHR)
Query!
Assessment method [4]
0
0
CHR=all of the following criteria: white blood cell count = institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils =20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Query!
Timepoint [4]
0
0
Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study
Query!
Secondary outcome [5]
0
0
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Query!
Assessment method [5]
0
0
Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count = institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils =20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Query!
Timepoint [5]
0
0
12 and 24 months
Query!
Secondary outcome [6]
0
0
Median Time From First Dosing Until CHR
Query!
Assessment method [6]
0
0
CHR=all of the following criteria: white blood cell count = institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils =20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Query!
Timepoint [6]
0
0
Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study
Query!
Secondary outcome [7]
0
0
Number of Participants With Major Molecular Response (MMR)
Query!
Assessment method [7]
0
0
MMR is defined as =3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.
Query!
Timepoint [7]
0
0
Baseline to 2 years
Query!
Secondary outcome [8]
0
0
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Query!
Assessment method [8]
0
0
Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.
Query!
Timepoint [8]
0
0
Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.
Query!
Secondary outcome [9]
0
0
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Query!
Assessment method [9]
0
0
AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Query!
Timepoint [9]
0
0
Continuously, from baseline through 2 years
Query!
Secondary outcome [10]
0
0
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Query!
Assessment method [10]
0
0
AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Query!
Timepoint [10]
0
0
Continuously, from baseline through 2 years
Query!
Secondary outcome [11]
0
0
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Query!
Assessment method [11]
0
0
Blood samples were collected for PK to be included in separate population PK analyses.
Query!
Timepoint [11]
0
0
Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.
Query!
Eligibility
Key inclusion criteria
- Age of 18 years and older.
- Chronic myeloid leukemia (CML)
- Previous treatment with imatinib at a dose of >600 mg/day AND the development of
progressive disease while receiving imatinib at that dose, OR
- CML with resistance to imatinib at a dose less than or equal to 600 mg/day with
genetic mutation in the BCR-ABL gene that is associated with a high level of
resistance to imatinib, OR
- Intolerance to imatinib at any dose
- Adequate organ function
- Women who are able to bear children must have a negative serum or urine pregnancy
test. Adequate methods of contraception must be used throughout the study to avoid
pregnancy for the entire interval of at least 1 month before and 3 months after
completion of the study medication.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Woman who are pregnant or breastfeeding
- Men whose sexual partners are women who are of childbearing potential, and who are
unwilling or unable to use an acceptable method to avoid pregnancy of his partner for
the entire study period as outlined above
- Previous diagnosis of accelerated phase or blast crisis CML.
- Participants who are eligible and willing to undergo transplantation during the
screening period
- Uncontrolled or significant cardiovascular disease
- Use of imatinib within 7 days.
- Use of interferon or cytarabine within 14 days
- Use of a targeted small-molecule anticancer agent within 14 days
- Use of certain medication that carry a known side effect risk of Torsade de Pointes -
Certain medications that irreversibly inhibit platelet function or anticoagulants
- Prior therapy with dasatinib.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
387
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - St. Leonards
Query!
Recruitment hospital [2]
0
0
Local Institution - South Brisbane
Query!
Recruitment hospital [3]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [4]
0
0
Local Institution - East Mebourne
Query!
Recruitment hospital [5]
0
0
Local Institution - Parkville
Query!
Recruitment postcode(s) [1]
0
0
- St. Leonards
Query!
Recruitment postcode(s) [2]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
- Adelaide
Query!
Recruitment postcode(s) [4]
0
0
- East Mebourne
Query!
Recruitment postcode(s) [5]
0
0
- Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Oregon
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Washington
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Wein
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
B-Leuven
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Bruxelles
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Edegem
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Yvoir
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
British Columbia
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Ontario
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Quebec
Query!
Country [30]
0
0
Denmark
Query!
State/province [30]
0
0
Aarhus
Query!
Country [31]
0
0
Finland
Query!
State/province [31]
0
0
Helsinki
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Lille Cedex
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Lyon Cedex 03
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Nantes
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Paris Cedex 10
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Pessac
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Poitiers Cedex
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Strasbourg Cedex
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Hamburg
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Leipzig
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Mainz
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Mannheim
Query!
Country [43]
0
0
Ireland
Query!
State/province [43]
0
0
Galway
Query!
Country [44]
0
0
Ireland
Query!
State/province [44]
0
0
Dublin
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Ramat-Gan
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Bari
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Bologna
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Milano
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Napoli
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Orbassano
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Roma
Query!
Country [52]
0
0
Korea, Republic of
Query!
State/province [52]
0
0
Kyunggi-Do
Query!
Country [53]
0
0
Netherlands
Query!
State/province [53]
0
0
Nijmegen
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Rotterdam
Query!
Country [55]
0
0
Norway
Query!
State/province [55]
0
0
Trondheim
Query!
Country [56]
0
0
Peru
Query!
State/province [56]
0
0
Lima
Query!
Country [57]
0
0
Singapore
Query!
State/province [57]
0
0
Singapore
Query!
Country [58]
0
0
South Africa
Query!
State/province [58]
0
0
Gauteng
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Barcelona
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Madrid
Query!
Country [61]
0
0
Sweden
Query!
State/province [61]
0
0
Gothenburg
Query!
Country [62]
0
0
Sweden
Query!
State/province [62]
0
0
Lund
Query!
Country [63]
0
0
Sweden
Query!
State/province [63]
0
0
Stockholm
Query!
Country [64]
0
0
Sweden
Query!
State/province [64]
0
0
Umea
Query!
Country [65]
0
0
Sweden
Query!
State/province [65]
0
0
Uppsala
Query!
Country [66]
0
0
Switzerland
Query!
State/province [66]
0
0
Basel
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Central
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Greater London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is assess the effects of the investigational drug dasatinib on
participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and
who are either resistant to or intolerant of imatinib. Other purposes of the study are to
identify any side effects the drug may produce and to study the level of dasatanib in the
blood and assess the efficacy of dasatanib in the treatment of leukemia.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00101660
Query!
Trial related presentations / publications
Hochhaus A, Kantarjian HM, Baccarani M, Lipton JH, Apperley JF, Druker BJ, Facon T, Goldberg SL, Cervantes F, Niederwieser D, Silver RT, Stone RM, Hughes TP, Muller MC, Ezzeddine R, Countouriotis AM, Shah NP. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007 Mar 15;109(6):2303-9. doi: 10.1182/blood-2006-09-047266. Epub 2006 Nov 30. Erratum In: Blood. 2007 Sep 1;110(5):1438.
Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00101660
Download to PDF
Show all queries