NCT01701349

Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Fosbretabulin Tromethamine (CA4P) in Combination With Paclitaxel and Carboplatin in Anaplastic Thyroid Carcinoma (FACT2)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mateon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC). The primary objective of the study is to determine overall survival. A maximum of 300 subjects will be recruited from approximately 75 multinational sites of which approximately 35 will be located in the United States.

Detailed description

The Treatment Plan followed for all subjects will consist of: * A Screening Visit within 14 days before study drug (fosbretabulin or placebo) administration * A Treatment Phase of 21-day combination treatment (study drug plus chemotherapy) cycles (up to 6 cycles) * An End of Treatment Phase assessment * An End of Study Visit occurring 30 days after the last day of study drug administration, as able After the last clinic visit, all subjects will be followed for survival by monthly phone calls, email, or in-person.

Conditions

• Anaplastic Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Fosbretabulin + paclitaxel + carboplatin	Fosbretabulin 200 mg/m2 IV infusion
DRUG	Placebo + paclitaxel + carboplatin	Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-04-01
• Completion: 2017-12-01
• First posted: 2012-10-05
• Last updated: 2014-05-01