DOVIGIST: Phase II trial to evaluate the efficacy and safety of TKI258 in patients with gastrointestinal stromal tumors
- Conditions
- GIST irresecable y/o metastásico, GIST recurrenteMedDRA version: 14.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001725-24-ES
- Lead Sponsor
- ovartis Farmacéutica S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s): ;Timepoint(s) of evaluation of this end point: 12 weeks after the first dose of study drug.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Efficacy: at day 28 of Cycle 1 then every 8 weeks until month six and then every 12 weeks until disease progression or starting other treatment.