Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00101816

First received: January 13, 2005

Last updated: August 3, 2010

Last verified: June 2010

History of Changes

Results First Received: December 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Chronic Myeloid Leukemia Blast Crisis
Intervention:	Drug: Dasatinib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 124 participants were enrolled in this study; 15 were never treated (11 participants did not meet inclusion criteria; 3 participants died; 1 participant failed screening).

Reporting Groups

Description

Imatinib-intolerant

Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.

Imatinib-resistant

Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.

Participant Flow: Overall Study

	Imatinib-intolerant	Imatinib-resistant
STARTED	10	99
COMPLETED	10	99
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Imatinib-intolerant	Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
Imatinib-resistant	Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
Total	Total of all reporting groups

Baseline Measures

	Imatinib-intolerant	Imatinib-resistant	Total
Number of Participants [units: participants]	10	99	109
Age, Customized [units: participants]
Between 21 and 45 years	1	35	36
Between 46 and 65 years	7	46	53
Between 66 and 75 years	1	18	19
>75 years	1	0	1
Age [units: years] Mean ± Standard Deviation	60.5 ± 10.9	50.4 ± 14.0	51.4 ± 14.0
Gender [units: participants]
Female	3	60	63
Male	7	39	46
Race/Ethnicity, Customized [units: Participants]
Asian	0	18	18
Black or African American	0	13	13
White	10	67	77
Other	0	1	1
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) ^[1] [units: Participants]
Score=0	1	21	22
Score=1	6	39	45
Score=2	2	33	35
Score=3	0	2	2
Score=4	0	0	0
Score=5	0	0	0
Not Reported	1	4	5
Functional Assessment of Cancer Therapy-General (FACT-G) ^[2] [units: units on a scale] Mean ± Standard Deviation
Total FACT-G	65.6 ± 7.1	69.2 ± 16.0	68.9 ± 15.4
Physical Well Being	17.2 ± 3.8	16.4 ± 6.3	16.5 ± 6.1
Social/Family Well-Being	20.1 ± 23.6	22.1 ± 4.7	21.9 ± 4.7
Emotional Well-Being	15.3 ± 2.1	16.8 ± 5.3	16.7 ± 5.2
Functional Well-Being	13.0 ± 4.5	13.9 ± 5.9	13.8 ± 5.7

[1]	ECOG PS, a 6-item scale to assess disease progression, daily fuctioning, and appropriate treatment and prognosis. Scale: 0-5, with 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Death.
[2]	FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Score range: 0-108; higher scores=better health-related quality of life. 7 participants in the Imatinib-Intolerant group had baseline measurements; 80 participants in the Imatinib-Resistant group had baseline measurements for all 4 domains and 79 had baseline measurements for Total FACT-G scores.

[1]

ECOG PS, a 6-item scale to assess disease progression, daily fuctioning, and appropriate treatment and prognosis. Scale: 0-5, with 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Death.

[2]

FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Score range: 0-108; higher scores=better health-related quality of life. 7 participants in the Imatinib-Intolerant group had baseline measurements; 80 participants in the Imatinib-Resistant group had baseline measurements for all 4 domains and 79 had baseline measurements for Total FACT-G scores.

Outcome Measures

Show All Outcome Measures

1. Primary:

Major and Overall Hematologic Response (MaHR and OHR) [ Time Frame: Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment ]

Show Outcome Measure 1

2. Secondary:

Median Duration of Major Hematologic Response (MaHR) [ Time Frame: Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment ]

Show Outcome Measure 2

3. Secondary:

Median Duration of Overall Hematologic Response (OHR) [ Time Frame: Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment ]

Show Outcome Measure 3

4. Secondary:

Time to MaHR and OHR [ Time Frame: Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment ]

Show Outcome Measure 4

5. Secondary:

Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response [ Time Frame: Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment ]

Show Outcome Measure 5

6. Secondary:

Number of Participants With CHR or NEL, MiHR, or no Hematologic Response [ Time Frame: Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment ]

Show Outcome Measure 6

7. Secondary:

Number of Participants Achieving Major Molecular Response (MMR) [ Time Frame: Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis ]

Show Outcome Measure 7

8. Secondary:

MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations [ Time Frame: baseline, at time of disease progression ]

Show Outcome Measure 8

9. Secondary:

Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up ]

Show Outcome Measure 9

10. Secondary:

Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs [ Time Frame: Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period ]

Show Outcome Measure 10

11. Secondary:

Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 11

12. Secondary:

Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T]) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 12

13. Secondary:

Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 13

14. Secondary:

Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 14

15. Secondary:

Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 15

16. Secondary:

Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T]) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 16

17. Secondary:

Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 17

18. Secondary:

Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF) [ Time Frame: Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours. ]

Show Outcome Measure 18

19. Secondary:

Population PK of Dasatinib [ Time Frame: Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose. ]

Show Outcome Measure 19

Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

Description

Imatinib-intolerant

Imatinib-resistant

Other Adverse Events

	Imatinib-intolerant	Imatinib-resistant
Total, other (not including serious) adverse events
# participants affected / at risk	10/10	97/99
Blood and lymphatic system disorders
ANAEMIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	14/99 (14.14%)
LEUKOPENIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	3/99 (3.03%)
NEUTROPENIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	13/99 (13.13%)
SPLENOMEGALY ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
THROMBOCYTOPENIA ^{† 1}
# participants affected / at risk	0/10 (0.00%)	17/99 (17.17%)
FEBRILE NEUTROPENIA ^{† 1}
# participants affected / at risk	0/10 (0.00%)	6/99 (6.06%)
Cardiac disorders
TACHYCARDIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	7/99 (7.07%)
TACHYARRHYTHMIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
ATRIAL FIBRILLATION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
PERICARDIAL EFFUSION ^{† 1}
# participants affected / at risk	0/10 (0.00%)	7/99 (7.07%)
LEFT VENTRICULAR DYSFUNCTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
Eye disorders
DRY EYE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
EYE OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
EYELID OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
EYE HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/10 (0.00%)	6/99 (6.06%)
RETINAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
CONJUNCTIVAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	8/99 (8.08%)
Gastrointestinal disorders
NAUSEA ^{† 1}
# participants affected / at risk	3/10 (30.00%)	34/99 (34.34%)
ASCITES ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
VOMITING ^{† 1}
# participants affected / at risk	6/10 (60.00%)	37/99 (37.37%)
DIARRHOEA ^{† 1}
# participants affected / at risk	5/10 (50.00%)	60/99 (60.61%)
DYSPEPSIA ^{† 1}
# participants affected / at risk	0/10 (0.00%)	11/99 (11.11%)
GASTRITIS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
PROCTALGIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
STOMATITIS ^{† 1}
# participants affected / at risk	3/10 (30.00%)	14/99 (14.14%)
ANAL FISSURE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
CONSTIPATION ^{† 1}
# participants affected / at risk	2/10 (20.00%)	21/99 (21.21%)
HAEMORRHOIDS ^{† 1}
# participants affected / at risk	2/10 (20.00%)	7/99 (7.07%)
HAEMATOCHEZIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	5/99 (5.05%)
ABDOMINAL PAIN ^{† 1}
# participants affected / at risk	0/10 (0.00%)	22/99 (22.22%)
INGUINAL HERNIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
LIP HAEMORRHAGE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
GINGIVAL BLEEDING ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
MOUTH HAEMORRHAGE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	6/99 (6.06%)
RECTAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
ABDOMINAL DISCOMFORT ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
ABDOMINAL PAIN UPPER ^{† 1}
# participants affected / at risk	2/10 (20.00%)	16/99 (16.16%)
GASTROINTESTINAL DISORDER ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
GASTROINTESTINAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/10 (0.00%)	10/99 (10.10%)
General disorders
PAIN ^{† 1}
# participants affected / at risk	1/10 (10.00%)	12/99 (12.12%)
CHILLS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	12/99 (12.12%)
OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	9/99 (9.09%)
FATIGUE ^{† 1}
# participants affected / at risk	3/10 (30.00%)	34/99 (34.34%)
PYREXIA ^{† 1}
# participants affected / at risk	8/10 (80.00%)	62/99 (62.63%)
ASTHENIA ^{† 1}
# participants affected / at risk	5/10 (50.00%)	25/99 (25.25%)
CHEST PAIN ^{† 1}
# participants affected / at risk	2/10 (20.00%)	13/99 (13.13%)
FACE OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
HYPOTHERMIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
PITTING OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
LOCALISED OEDEMA ^{† 1}
# participants affected / at risk	3/10 (30.00%)	4/99 (4.04%)
OEDEMA PERIPHERAL ^{† 1}
# participants affected / at risk	3/10 (30.00%)	35/99 (35.35%)
GENERALISED OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	2/99 (2.02%)
MUCOSAL INFLAMMATION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	5/99 (5.05%)
INFLUENZA LIKE ILLNESS ^{† 1}
# participants affected / at risk	2/10 (20.00%)	1/99 (1.01%)
Hepatobiliary disorders
CHOLELITHIASIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
HYPERBILIRUBINAEMIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
GALLBLADDER ENLARGEMENT ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
HEPATIC FUNCTION ABNORMAL ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
Immune system disorders
ALLERGY TO ARTHROPOD BITE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
Infections and infestations
RHINITIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
PNEUMONIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	3/99 (3.03%)
ORAL HERPES ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
PHARYNGITIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	3/99 (3.03%)
FOLLICULITIS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
GASTROENTERITIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	6/99 (6.06%)
NASOPHARYNGITIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	7/99 (7.07%)
ORAL CANDIDIASIS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	7/99 (7.07%)
VAGINAL INFECTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
LOCALISED INFECTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
CLOSTRIDIAL INFECTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
FUNGAL SKIN INFECTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
URINARY TRACT INFECTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	8/99 (8.08%)
UPPER RESPIRATORY TRACT INFECTION ^{† 1}
# participants affected / at risk	0/10 (0.00%)	7/99 (7.07%)
URINARY TRACT INFECTION BACTERIAL ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
ESCHERICHIA URINARY TRACT INFECTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
Injury, poisoning and procedural complications
CONTUSION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
SKIN LACERATION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
Investigations
CARDIAC MURMUR ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
WEIGHT DECREASED ^{† 1}
# participants affected / at risk	5/10 (50.00%)	25/99 (25.25%)
WEIGHT INCREASED ^{† 1}
# participants affected / at risk	2/10 (20.00%)	21/99 (21.21%)
ASPARTATE AMINOTRANSFERASE INCREASED ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
Metabolism and nutrition disorders
ANOREXIA ^{† 1}
# participants affected / at risk	3/10 (30.00%)	25/99 (25.25%)
HYPOKALAEMIA ^{† 1}
# participants affected / at risk	0/10 (0.00%)	6/99 (6.06%)
HYPOCALCAEMIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	3/99 (3.03%)
FLUID OVERLOAD ^{† 1}
# participants affected / at risk	1/10 (10.00%)	2/99 (2.02%)
DECREASED APPETITE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	3/99 (3.03%)
Musculoskeletal and connective tissue disorders
MYALGIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	11/99 (11.11%)
MYOSITIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
BACK PAIN ^{† 1}
# participants affected / at risk	0/10 (0.00%)	15/99 (15.15%)
BONE PAIN ^{† 1}
# participants affected / at risk	1/10 (10.00%)	16/99 (16.16%)
ARTHRALGIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	15/99 (15.15%)
MUSCULAR WEAKNESS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	5/99 (5.05%)
PAIN IN EXTREMITY ^{† 1}
# participants affected / at risk	0/10 (0.00%)	17/99 (17.17%)
MUSCULOSKELETAL PAIN ^{† 1}
# participants affected / at risk	0/10 (0.00%)	6/99 (6.06%)
Nervous system disorders
COMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
APHASIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	2/99 (2.02%)
HEADACHE ^{† 1}
# participants affected / at risk	3/10 (30.00%)	31/99 (31.31%)
LETHARGY ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
DIZZINESS ^{† 1}
# participants affected / at risk	2/10 (20.00%)	14/99 (14.14%)
CONVULSION ^{† 1}
# participants affected / at risk	0/10 (0.00%)	6/99 (6.06%)
SOMNOLENCE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	2/99 (2.02%)
PARAESTHESIA ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
HYPOAESTHESIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	2/99 (2.02%)
Psychiatric disorders
ANXIETY ^{† 1}
# participants affected / at risk	1/10 (10.00%)	8/99 (8.08%)
INSOMNIA ^{† 1}
# participants affected / at risk	2/10 (20.00%)	13/99 (13.13%)
AGITATION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
DEPRESSION ^{† 1}
# participants affected / at risk	0/10 (0.00%)	8/99 (8.08%)
DEPRESSED MOOD ^{† 1}
# participants affected / at risk	2/10 (20.00%)	1/99 (1.01%)
CONFUSIONAL STATE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
Reproductive system and breast disorders
NIPPLE PAIN ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
VAGINAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
Respiratory, thoracic and mediastinal disorders
COUGH ^{† 1}
# participants affected / at risk	3/10 (30.00%)	40/99 (40.40%)
RALES ^{† 1}
# participants affected / at risk	0/10 (0.00%)	5/99 (5.05%)
HYPOXIA ^{† 1}
# participants affected / at risk	3/10 (30.00%)	2/99 (2.02%)
DYSPNOEA ^{† 1}
# participants affected / at risk	4/10 (40.00%)	30/99 (30.30%)
EPISTAXIS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	21/99 (21.21%)
HAEMOPTYSIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	6/99 (6.06%)
PNEUMONITIS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	6/99 (6.06%)
NASAL DISORDER ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
PLEURITIC PAIN ^{† 1}
# participants affected / at risk	1/10 (10.00%)	2/99 (2.02%)
PLEURAL EFFUSION ^{† 1}
# participants affected / at risk	3/10 (30.00%)	34/99 (34.34%)
PRODUCTIVE COUGH ^{† 1}
# participants affected / at risk	0/10 (0.00%)	8/99 (8.08%)
PULMONARY OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	5/99 (5.05%)
THROAT TIGHTNESS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
DYSPNOEA EXERTIONAL ^{† 1}
# participants affected / at risk	0/10 (0.00%)	7/99 (7.07%)
RESPIRATORY FAILURE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
PULMONARY THROMBOSIS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
PHARYNGOLARYNGEAL PAIN ^{† 1}
# participants affected / at risk	0/10 (0.00%)	7/99 (7.07%)
PULMONARY HYPERTENSION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
RESPIRATORY TRACT CONGESTION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	1/99 (1.01%)
Skin and subcutaneous tissue disorders
ACNE ^{† 1}
# participants affected / at risk	0/10 (0.00%)	6/99 (6.06%)
RASH ^{† 1}
# participants affected / at risk	2/10 (20.00%)	25/99 (25.25%)
PURPURA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
ERYTHEMA ^{† 1}
# participants affected / at risk	2/10 (20.00%)	8/99 (8.08%)
PRURITUS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	10/99 (10.10%)
PETECHIAE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	12/99 (12.12%)
ECCHYMOSIS ^{† 1}
# participants affected / at risk	0/10 (0.00%)	10/99 (10.10%)
SKIN ULCER ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
SKIN LESION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	4/99 (4.04%)
NIGHT SWEATS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	9/99 (9.09%)
HYPERHIDROSIS ^{† 1}
# participants affected / at risk	2/10 (20.00%)	4/99 (4.04%)
SPIDER NAEVUS ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
SWELLING FACE ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)
PERIORBITAL OEDEMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	8/99 (8.08%)
Vascular disorders
HAEMATOMA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	7/99 (7.07%)
HYPOTENSION ^{† 1}
# participants affected / at risk	1/10 (10.00%)	13/99 (13.13%)
HYPERTENSION ^{† 1}
# participants affected / at risk	0/10 (0.00%)	12/99 (12.12%)
PERIPHERAL ISCHAEMIA ^{† 1}
# participants affected / at risk	1/10 (10.00%)	0/99 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com

Publications:

Cortes J, Rousselot P, Kim DW, Ritchie E, Hamerschlak N, Coutre S, Hochhaus A, Guilhot F, Saglio G, Apperley J, Ottmann O, Shah N, Erben P, Branford S, Agarwal P, Gollerkeri A, Baccarani M. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007 Apr 15;109(8):3207-13. Epub 2006 Dec 21.

Porkka K, Koskenvesa P, Lundán T, Rimpiläinen J, Mustjoki S, Smykla R, Wild R, Luo R, Arnan M, Brethon B, Eccersley L, Hjorth-Hansen H, Höglund M, Klamova H, Knutsen H, Parikh S, Raffoux E, Gruber F, Brito-Babapulle F, Dombret H, Duarte RF, Elonen E, Paquette R, Zwaan CM, Lee FY. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia. Blood. 2008 Aug 15;112(4):1005-12. Epub 2008 May 13.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00101816 History of Changes
Obsolete Identifiers:	NCT00108719
Other Study ID Numbers:	CA180-006
Study First Received:	January 13, 2005
Results First Received:	December 15, 2009
Last Updated:	August 3, 2010
Health Authority:	United States: Food and Drug Administration

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