Clinical Trials Logo

Clinical Trial Summary

The study will investigate the comparative efficacy and safety of two oral inhibitors of Kit and PDGFR: nilotinib 400 mg bid, a novel agent, and imatinib 400 mg bid, an approved agent with an established efficacy.


Clinical Trial Description

This is an international, randomized, open-label, double-arm, phase III trial that will be conducted in centers in Latin America, Asia, Europe and Canada. The study will be sponsored by Novartis Pharmaceuticals Corporation. Patient enrollment will be competitive and will have a duration of up to 30 months. An interim analysis is planned to occur when approximately 60% of the PFS events occurs. A total of 150 patients per arm will be enrolled in the study. Eligible patients will have advanced/metastatic, inoperable GIST of any anatomical location or recurrent GIST while on or post imatinib adjuvant therapy, with documented disease progression on therapy with imatinib 400 mg q.d. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00751036
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 3
Start date June 2009
Completion date August 2012

See also
  Status Clinical Trial Phase
Recruiting NCT05385549 - 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk Phase 2
Recruiting NCT05905887 - Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor Phase 2
Completed NCT01933958 - Regorafenib Post-marketing Surveillance in Japan
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Completed NCT01440959 - Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258 Phase 2
Completed NCT00718562 - Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib Phase 2
Completed NCT00385203 - The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST). Phase 2
Completed NCT00137449 - Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor Phase 2
Completed NCT00237172 - Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study) Phase 2
Terminated NCT04409223 - Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib Phase 3
Active, not recruiting NCT03556384 - Temozolomide (TMZ) In Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST) Phase 2
Recruiting NCT04106024 - Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial Phase 2
Completed NCT02171286 - The Oncopanel Pilot (TOP) Study N/A
Completed NCT01114087 - Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility N/A
Recruiting NCT05366816 - ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST Phase 2
Recruiting NCT03602092 - Observational Registry Data on GIST Patients
Recruiting NCT05197933 - Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach N/A
Completed NCT02931929 - MITIGATE-NeoBOM: A Study to Evaluate 68Ga- NeoBOMB1 in Patients With Advanced TKI-treated GIST Using PET/CT Phase 1/Phase 2
Withdrawn NCT05080621 - Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST) Phase 1/Phase 2
Completed NCT02607332 - Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib Phase 2