Gastrointestinal Stromal Tumors
Conditions
Keywords
Oncology, Cancer, Imatinib-Resistant Gastrointestinal Stromal Tumors, GIST, Nilotinib, Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)
Brief summary
To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST
Interventions
Nilotinib 50 mg and 200 mg gelatin capsules and Imatinib 100 mg and 400 mg film-coated tablets in bottles.. Medication labels for each study drug complied with the legal requirements of each country, were printed in the local language.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Documented Complete Response, Partial Response, or Stable Disease at the time of entry to extension study and/or possible benefit from continuing treatment in the view of the investigator. * Normal organ and marrow function as defined in core protocol (CAMN107A2103). * Extension protocol written informed consent.
Exclusion criteria
* Inability to swallow the medication. * Any unresolved adverse events related to participation in the core protocol (CAMN107A2103). * A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits. Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of nilotinib either as single agent or in combination with Imatinib | AE monitored continuously from day 1 cycle 1 to the study completion visit; safety laboratory and cardiac safety monitored every 3 treatment cycles (every 3 months) from day 1 cycle 1 to the study completion visit | Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess any clinical responses in Imatinib-resistant GIST patients. Assessment of tumor response will be made based on modified RECIST criteria - to be assessed at the end of every cycle of treatment | every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit | Assessment of tumor response will be made based on modified RECIST criteria. |
Countries
France, Italy, United States
Outcome results
None listed