Trial record 12 of 3248 for:
Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator
This study is currently recruiting participants.
Verified September 2013 by Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: November 28, 2012
Last updated: September 25, 2013
Last verified: September 2013
The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.
GIST and CML
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open Label, Multi-center Imatinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Imatinib Study and Are Judged by the Investigator to Benefit From Continued Imatinib Treatment
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2018 (Final data collection date for primary outcome measure)
Experimental: STI571 (imatinib mesylate)
STI571 (imatinib mesylate)
Other Name: Glivec/Gleevec
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving imatinib and has fulfilled all their requirements in the parent study. 2.Patient is currently benefiting from the treatment with imatinib, as determined by the investigator. 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. Written informed consent obtained prior to enrolling in roll-over study.
- 1. Patient has been permanently discontinued from imatinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
- Patient has participated in a Novartis sponsored combination trial where imatinib was dispensed in combination with another study medication and patient is still receiving combination therapy.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of imatinib. Male patients must use highly effective contraception during the study and for 30 days after the final dose of imatinib.
Highly effective contraception is defined as either:
If a study patient becomes pregnant or suspects being pregnant during the study or within 30 days after the final dose of imatinib, the investigator needs to be informed immediately and ongoing study treatment with imatinib has to be stopped
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742299
|Contact: Novartis Pharmaceuticals
|Contact: Novartis Pharmaceuticals
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 28, 2012
||September 25, 2013
||United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Haute Autorit? de Sant? Transparency Commission
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: National Institute of Health
Finland: Finnish Medicines Agency
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action