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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

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002846-38-GB
Enrollment
180
Registered
2007-07-26
Start date
2007-12-06
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaplastic Thyroid Carcinoma MedDRA version: 9.1 Level: PT Classification code 10002240 Term: Anaplastic thyroid cancer

Interventions

Product Name: Combretastatin A 4 Phosphate Pharmaceutical Form: Solution for injection INN or Proposed INN: Combretstatin a 4 phosphate Other descriptiv

Sponsors

OXiGENE, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Tumors confined to the thyroid or an uncontrolled active infection or clinically evident brain metastasis

Design outcomes

Primary

MeasureTime frame
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; Secondary Objective: To evaluate the safety and tolerability of the triple combination of combretastatin A-4 phosphate + paclitaxel + carboplatin To assess specified objective events: tracheostomies, PEG tube placements, and weight loss ;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—

Countries

Bulgaria, Italy, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026