zzz-to be deleted-Advanced Anaplastic Thyroid Cancer Study
Phase 1/2 Study of CS-7017, an Oral PPAR Agonist, in Combination with Paclitaxel in Subjects with Advanced Anaplastic Thyroid Cancer.
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.
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.
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.firstname.lastname@example.org.
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: email@example.com
Web Site: www.thyca.org