Spots Global Cancer Trial Database for Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer

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Trial Identification

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

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)

Study ID: NCT01701349

Conditions

Anaplastic Thyroid Cancer

Interventions

Fosbretabulin + paclitaxel + carboplatin

Placebo + paclitaxel + carboplatin

Study Description

Brief 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.