A multicenter, open-label, randomized, phase II/III study to evaluate the safety and efficacy of combretastatin a-4 phosphate in combination with paclitaxel and carboplatin in comparison with paclitaxel and carboplatin against anaplastic thyroid carcinoma - N/A
Phase 1
Active, not recruiting
- Conditions
- Anaplastic Thyroid CarcinomaMedDRA version: 9.1 Level: PT Classification code 10002240 Term: Anaplastic thyroid cancer
- Registration Number
- EUCTR2007-002846-38-GB
- Lead Sponsor
- OXiGENE, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
Anaplastic thyroid carcinoma histologically or cytologically confirmed pathology, having been refractory to or progressed during or after therapy,. or relapsed within 6 months following initial combined modality therapy
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Tumors confined to the thyroid or an uncontrolled active infection or clinically evident brain metastasis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the antineoplastic efficacy of combretastatin A-4 phosphate + paclitaxel + carboplatin+ with paclitaxel + carboplatin against anaplastic thyroid carcinoma by measuring overall survival;<br> Secondary Objective: To evaluate the safety and tolerability of the triple combination of combretastatin A-4 phosphate + paclitaxel + carboplatin<br> To assess specified objective events: tracheostomies, PEG tube placements, and weight loss<br> ;Primary end point(s): To compare the antineoplastic efficacy of combretastatin A-4 phosphate + paclitaxel + carboplatin+ with paclitaxel + carboplatin against anaplastic thyroid carcinoma by measuring overall survival
- Secondary Outcome Measures
Name Time Method