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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: November 28, 2012
Last updated: May 15, 2015
Last verified: May 2015
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2023 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742299
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 28, 2012
||May 15, 2015
||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 August 27, 2015
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors