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

NCT01701349 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-05-01

No results posted yet for this study

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.

Conditions

  • Anaplastic Thyroid Cancer

Interventions

DRUG

Fosbretabulin + paclitaxel + carboplatin

Fosbretabulin 200 mg/m2 IV infusion

DRUG

Placebo + paclitaxel + carboplatin

Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion

Sponsors & Collaborators

  • Mateon Therapeutics

    lead INDUSTRY

Principal Investigators

  • Marcia Brose, MD, PhD · University of Pennsylvania, Philadelphia, PA 19104

  • Julie A Sosa, MD · Yale University, New Haven, CT 06520

  • Lisa Licitra, MD · Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-04-30
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701349 on ClinicalTrials.gov