Pazopanib as treatment for advanced gastrointestinal stromal tumors not any longer responding to standard treatment with the drugs imatinib or sunitinib - A study without comparator as placebo or another drug, performed at many sites and sponsored by the Scandinavian Sarcoma Group
- Conditions
- Gatrointestinal stromal tumor (GIST)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004404-37-DK
- Lead Sponsor
- Scandinavian Sarcoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
a) metastatic and/or locally advanced GIST
b) measurable disease as defined by RECIST
c) progressive disease after both imatinib and sunitinib treatment, and also after nilotinib if this drug ha been given
d) no other tyrosin kinase inhibitors given than imatinib, sunitinib, and nilotinib
e) age at least 18 years
f) WHO performance status 0-2
g) resolution of toxic side effects from earlier treatment
h) sufficient organ functions as defined in the protocol
i) acceptence to use adequate contraception throughout the study period for women with childbearing potential
j) written informed consent
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
a) prior malignancy if claiming active treatment or otherwise is judged to be of significance for the study treatment
b) clinically significant gastrointestinal bleeding
c) uncontrolled infection of significance
d) major surgery or trauma within 28 days priot to the start of study treatment
e) active bleeding or bleeding diathesis
f) uncontrolled hypertension
g) endobronchial lesions or lesions infiltrating major pulmonary vessels
h) medical, psychiatric or other condition that could interfere with safety or compliance
i) pregnancy or lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Calculate the disease control rate (DCR)=complete remission (CR)+partial remission (PR) + stable disease (SD) at 12 weeks;Secondary Objective: 1. Calculate overall response rate (ORR=CR+PR) at the time of best response since start of pazopanib<br>2. Calculate progression free survival (PFS) for patients administered pazopanib<br>3. Calculate DCR in relation to mutational status of primary tumor sample<br>4. Calculate DCR in relation to plasma concentration at week 12<br>5. Assess the toxicity in patients treated with pazopanib;Primary end point(s): Disease control rate (DCR=CR+PR+SD) at 12 weeks from start of pazopanib treatment according to RECIST version 1.1;Timepoint(s) of evaluation of this end point: 12 weeks from start of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Overall response rate (ORR) defined as the fraction of patients ever achieving CR or PR during protocol treatment<br>2. Progression free survival (PFS) defined as the time from start of pazopanib to progressive disease according to RECIST version 1.1<br>3. DCR in relation to mutational status of primary tumor sample<br>4. DCR in relation to plasma concentration of pazopanib at week 12 of treatment<br>5. Toxicity defined as adverse events and abnormal laboratory test results;Timepoint(s) of evaluation of this end point: For 1, 2, and 5 above - continously during protocol treatment; for 5 also including 30 days after end of treatment<br><br>For 3 and 4 - at week 12 of treatment