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NCT00982488 Clinical Trial

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

Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00982488
Other study ID # CA180-188
Secondary ID 2007-003624-37
Status Completed
Phase Phase 2
First received September 16, 2009
Last updated December 16, 2015
Start date October 2007
Est. completion date December 2014

Study information
Verified date December 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesGermany: Ministry of HealthPeru: Instituto Nacional de SaludArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaSwitzerland: Federal Office of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBrazil: National Health Surveillance AgencyKorea: Food and Drug AdministrationBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentFinland: National Advisory Board on Health Care EthicsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsIreland: Irish Medicines BoardSouth Africa: Medicines Control CouncilThailand: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationBrazil: Ethics CommitteeFinland: Finnish Medicines AgencyFinland: Data Protection BoardThailand: Ministry of Public HealthPoland: National Institute of MedicinesPoland: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 238
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
• Imatinib
Imatinib was supplied as 100- and 400-mg tablets.

Locations
Country Name City State
Argentina Local Institution Buenos Aires
Argentina Local Institution Buenos Aires
Argentina Local Institution Capital Federal Buenos Aires
Australia Local Institution Adelaide South Australia
Belgium Local Institution Mont-godinne
Brazil Local Institution Campinas San Paulo
Brazil Local Institution Curitiba Parana
Brazil Local Institution Rio de Janeiro
Brazil Local Institution Sao Paulo
Brazil Local Institution Sao Paulo
Canada Local Institution Montreal Quebec
Canada Local Institution Toronto Ontario
Finland Local Institution Helsinki
France Local Institution Lille
France Local Institution Lyon Cedex 03
France Local Institution Nantes
France Local Institution Paris
France Local Institution Pessac
France Local Institution Poitiers Cedex
France Local Institution Strasbourg
Germany Local Institution Hamburg
Germany Local Institution Leipzig
Germany Local Institution Mannheim
Hungary Local Institution Budapest
Ireland Local Institution Dublin 8 Dublin
Israel Local Institution Ramat-gan
Italy Local Institution Bologna
Italy Local Institution Napoli
Italy Local Institution Orbassano (to)
Italy Local Institution Roma
Korea, Republic of Local Institution Jeollanam-do
Korea, Republic of Local Institution Seoul
Norway Local Institution Trondheim
Peru Local Institution Lima
Peru Local Institution Lima
Poland Local Institution Katowice
Poland Local Institution Krakow
Poland Local Institution Lodz
Poland Local Institution Lublin
Poland Local Institution Warsaw
Russian Federation Local Institution Moscow
Russian Federation Local Institution St.petersburg
South Africa Local Institution Groenkloof Gauteng
South Africa Local Institution Parktown Gauteng
Spain Local Institution Barcelona
Sweden Local Institution Gothenburg
Sweden Local Institution Lund
Sweden Local Institution Stockholm
Sweden Local Institution Umea
Sweden Local Institution Uppsala
Switzerland Local Institution Basel
Thailand Local Institution Bangkok
United Kingdom Local Institution Glasgow Scotland
United Kingdom Local Institution London Greater London
United Kingdom Local Institution Newcastle Tyne And Wear
United States Pacific Cancer Medical Center Inc Anaheim California
United States University Of Michigan Medical Center Ann Arbor Michigan
United States Dana Faber Cancer Institute Boston Massachusetts
United States University Of Chicago Chicago Illinois
United States Ut Southwestern Medical Center At Dallas Dallas Texas
United States Wayne State University Detroit Michigan
United States John Theurer Cancer Center Hackensack New Jersey
United States The University Of Texas Md Anderson Cancer Center Houston Texas
United States Central Indiana Cancer Centers Indianapolis Indiana
United States Loma Linda University Cancer Center Loma Linda California
United States Ucla Department Of Medicine Los Angeles California
United States Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Oregon Health & Sci Univ Portland Oregon
United States Stanford University School Of Medicine Stanford California
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida
United States Kaiser Permanente Medical Center Vallejo California
United States University Of Kansas Medical Center Westwood Kansas

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Norway,  Peru,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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