The purpose of this study is to better characterize the long-term safety of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Global Development \& Global Medical Affairs (OGD\&GMA) study and are benefiting from the treatment as judged by the investigator.
The study will not include a screening phase as patients will transfer directly from parent studies and will commence treatment with imatinib as soon as they are consented and meet the inclusion criteria of the roll-over protocol. Patients will continue to be treated until they are no longer benefiting from imatinib treatment, develop unacceptable toxicities, withdraw consent, are non-compliant to the protocol, the investigator feels it is no longer in the patient's best interest to continue imatinib therapy or the patient dies, whichever comes first. Patients are allowed to switch to the commercial supply in accordance with the regulation of the respective country. A patient will reach the end of study when imatinib treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 30 days after the last dose of study treatment. Following this there are no further follow-up study visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Imatinib will be provided as 100 mg and 400 mg tablets taken orally once daily unless other wise instructed by investigator
Frequency and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluation of long-term safety based on the frequency and severity of adverse events and serious adverse events occurring during the study.
Time frame: From first dose of study treatment until 30 days after the last dose of study treatment, assessed up to approximately 13 years
Frequency and severity of Adverse Events (AEs) / Serious Adverse Events (SAEs)
To evaluate long term safety data (SAEs and AEs)
Time frame: Until no patients are left on study, with an expected average of 20 years
Proportion of Participants With Clinical Benefit as Assessed by the Investigator
Assessment of continued clinical benefit based on investigator evaluation during scheduled study visits.
Time frame: Up to approximately 13 years
Proportion of patients with clinical benefit as assessed by the investigator
To evaluate clinical benefit as assessed by the investigator
Time frame: Until no patients are left on study, with an expected average of 20 years
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University of California LA
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
Sidney Kimmel CCC At JH
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Weill Cornell Medical Center
New York, New York, United States
Oregon Health Sciences University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States
Novartis Investigative Site
Nanjing, Jiangsu, China
...and 19 more locations