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

NCT00982488 | Completed Phase 2 Results

• 2 other identifiers: CA180-1882007-003624-37
• Study Type: interventional
• Target: 238
• Locations: 24 countries
• Sites: 72

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.

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 of treatment through a maximum of 82 months + 30 days

Study Arms (5)

Dasatinib, 50 mg QD to 120 mg BID, Chronic phase

OTHER

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

Imatinib, 400 mg BID, Chronic phase

OTHER

Participants with chronic phase disease received 400 mg of imatinib twice BID.

Drug: Imatinib

Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP

OTHER

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, 50 mg QD to 120 mg BID, Advanced phase, MBP

OTHER

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, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL

OTHER

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

Interventions

Dasatinib DRUG

Dasatinib was supplied as 20- and 50-mg tablets.

Also known as: BMS-354825, Sprycel, Src Kinase

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; Dasatinib, 50 mg QD to 120 mg BID, Chronic phase

Imatinib DRUG

Imatinib was supplied as 100- and 400-mg tablets.

Also known as: Gleevec/Glivec

Imatinib, 400 mg BID, Chronic phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (72)

Pacific Cancer Medical Center Inc

Anaheim, California, 92801, United States

Location

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

Location

Ucla Department Of Medicine

Los Angeles, California, 90095, United States

Location

Stanford University School Of Medicine

Stanford, California, 94305, United States

Location

Kaiser Permanente Medical Center

Vallejo, California, 94589, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

University Of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Dana Faber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University Of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Oregon Health & Sci Univ

Portland, Oregon, 97239, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

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Ut Southwestern Medical Center At Dallas

Dallas, Texas, 75390, United States

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The University Of Texas Md Anderson Cancer Center

Houston, Texas, 77030, United States

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Local Institution

Buenos Aires, Buenos Aires, 1021, Argentina

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Buenos Aires, Buenos Aires, 1280, Argentina

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Capital Federal, Buenos Aires, 1425, Argentina

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Adelaide, South Australia, 5000, Australia

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Mont-godinne, 5530, Belgium

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Curitiba, Paraná, 80060, Brazil

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Rio de Janeiro, Rio de Janeiro, 20231, Brazil

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Campinas, São Paulo, 13083, Brazil

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São Paulo, São Paulo, 05403, Brazil

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São Paulo, São Paulo, 05652, Brazil

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Toronto, Ontario, M4X 1K9, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Helsinki, 00029, Finland

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Lille, 59000, France

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Lyon, 69437, France

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Nantes, 44035, France

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Paris, 75475, France

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Pessac, 33604, France

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Poitiers, 86021, France

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Strasbourg, 67091, France

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Hamburg, 20246, Germany

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Leipzig, 04103, Germany

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Mannheim, 68167, Germany

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Budapest, 1097, Hungary

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Dublin, Dublin, Ireland

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Ramat Gan, 52621, Israel

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Bologna, 40138, Italy

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Napoli, 80131, Italy

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Orbassano (to), 10043, Italy

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Roma, 00144, Italy

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Trondheim, 7006, Norway

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Lima, Lima Province, 34, Peru

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Lima, Lima Province, LIMA II, Peru

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Katowice, 40032, Poland

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Krakow, 31501, Poland

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Lodz, 93-510, Poland

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Lublin, 20081, Poland

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Warsaw, 02097, Poland

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Moscow, 125167, Russia

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Saint Petersburg, 179089, Russia

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Groenkloof, Gauteng, 0181, South Africa

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Parktown, Gauteng, 2193, South Africa

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Jeollanam-do, 519-809, South Korea

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Seoul, 137-040, South Korea

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Barcelona, 08036, Spain

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Gothenburg, 41345, Sweden

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Lund, 221 85, Sweden

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Stockholm, SE-17176, Sweden

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Umeå, 901 85, Sweden

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Uppsala, 751 85, Sweden

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Basel, 4031, Switzerland

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Bangkok, 10400, Thailand

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London, Greater London, W12 OHS, United Kingdom

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Glasgow, Scotland, G12 OXB, United Kingdom

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Newcastle, Tyne and Wear, NE2 4HH, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Leukemia

Interventions

Dasatinib; src-Family Kinases; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 23, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 22, 2016
• Results First Posted: January 22, 2016

Record last verified: 2015-12

Locations

IE (1); US (17); IL (1); SE (5); CH (1); PE (2); RU (2); BE (1); PL (5); AR (3); ZA (2); ES (1); GB (3); FI (1); DE (3); NO (1); TH (1); CA (2); FR (7); HU (1); IT (4); AU (1); KR (2); BR (5)