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Advanced
Anaplastic Thyroid Cancer Study
Study Title:
Phase 1/2 Study of CS-7017, an Oral PPAR Agonist, in Combination with
Paclitaxel in Subjects with Advanced Anaplastic Thyroid Cancer.
Study Design:
This is an open-label, multicenter study for first-line treatment of
advanced anaplastic thyroid cancer (ATC). It includes a dose escalation
portion (Phase 1) in which the recommended Phase 2 dose of CS-7017 and
paclitaxel will be determined. In Phase 2 the efficacy and safety of
the combination at the determined dose level will be evaluated.
During both portions
of the study, there will be a 1 week run in segment with CS 7017 administered
alone. CS 7017 will be administered by mouth twice a day. Paclitaxel
will be administered as an intravenous infusion over 3 hours once every
3 weeks. Treatment will continue until disease progression, unacceptable
toxicity, or consent withdrawal. After discontinuation from the study,
the subject will be contacted at 3 month intervals to obtain information
about subsequent treatment(s) and survival status.
Eligibility Overview:
To be eligible for the Phase I portion of this study, a patient must
have advanced ATC with lesion(s) accessible for repeated biopsy. The
potential subject must be at least 18 years of age and have adequate
organ and bone marrow function. The patient cannot have a medical history
of diabetes that requires treatment with insulin or oral agents and
cannot have significant lung or heart disease. Pregnant and breast feeding
women are not allowed onto this study.
Further Information:
Ten study sites in the US are participating in this study. For further
information about this study, you and/or your health care provider may
contact the study center manager, Shirley Deasy (ICON Clinical Research)
at 919-554-0741, Shirley.deasy@iconplc.com.
For further information
about Anaplastic Thyroid Cancer, please contact:
ThyCa: Thyroid Cancer Survivors' Association, Inc.
Toll-free number 1-877-588-7904
E-mail address: thyca@thyca.org
Web Site: www.thyca.org
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