Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib
- Registration Number
- NCT00756509
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this multicenter, single-arm, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
- Detailed Description
The study planned a 6-month recruitment phase to enroll 40 subjects, followed by a 6-month treatment phase with monthly visits. Patients benefiting from the treatment could continue during a follow-up phase.
On May 5, 2011, Novartis decided to discontinue the ongoing clinical trials with Nilotinib in GIST. This decision was influenced by the discontinuation of the ENESTg1 study (CAMN107G2301), which showed that Nilotinib was unlikely to demonstrate superiority to Imatinib in progression-free survival, the primary endpoint. The independent Data Management Committee (DMC) also reported no safety issues in either trial arm. Following the decision to close-out the Novartis- Sponsored studies CAMN107G2301 (NCT00785785) and CAMN107DDE05 (NCT01289028), the enrollment of the study CAMN107DDE06 was re-opened in order to ensure continued access to nilotinib to the patients currently in the CAMN107G2301 trial and CAMN107DDE05 trial in Germany and benefiting from the nilotinib treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description nilotinib Nilotinib nilotinib
- Primary Outcome Measures
Name Time Method Best Overall Response at month 6 determined according to the RECIST criteria based on local radiological assessments 6 months Proportion of patients showing stable disease (SD), partial response (PR) or complete response (CR) during the first 6 months according to RECIST criteria
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) 6 months Duration of Response (DOR) is defined as the time from onset of response (CR/PR) to objective tumor progression or death from any cause.
Progression-free Survival (PFS) 6 months Progression-free Survival (PFS) is defined as the time from first study drug administration to objective tumor progression or death from any cause.
Objective Response Rate (ORR) 6 months Objective Response Rate (ORR) is defined as the proportion of patients in whom a complete (CR) or partial (PR) response was observed according to RECIST at month 6.
Incidence rate of adverse events (AEs) 6 months The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
Time to Response (TTR) 6 months Time to Response (TTR) is defined as the time from start of treatment to the first objective tumor response (PR or CR) observed.
Overall Survival (OS) 6 months Overall Survival (OS) is defined as the time from first study drug administration to death from any cause.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇮🇹Milano, MI, Italy
Novartis Investigative Site🇮🇹Milano, MI, Italy