Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer — FACT2  

Anaplastic Thyroid Cancer Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaplastic Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

• NCT number: NCT01701349
• Study type: Interventional
• Source: OXiGENE
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 2015
• Completion date: December 2017