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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Fosbretabulin 200 mg/m2 IV infusion
Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion
Overall survival
Time frame: Maximun length of study for each subject is 2 years from date of randomization
Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin
Time frame: Maximun length of study for each subject is 2 years from date of randomization
Number of participants with 1-year survival
Time frame: Maximun length of study for each subject is 2 years from date of randomization
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