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Brief Title: A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel
Official Title: A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel in Subjects With Advanced Anaplastic Thyroid Cancer
Study ID: NCT00603941
Brief Summary: The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of the first study cycle (week 3 of combination therapy), in order to evaluate the effects of the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment will continue until disease progression or the development of intolerable toxicities.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Univ of Colorado Cancer Center, Aurora, Colorado, United States
Mayo Clinic, Jacksonville, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University, Siteman Cancer Center, Saint Louis, Missouri, United States
Ohio State Univ, Columbus, Ohio, United States
Oregon Health Science Univ, Portland, Oregon, United States
University of Pennsylvania Maloney Hospital, Philadelphia, Pennsylvania, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Eastern Virginia Medical School, Norfolk, Virginia, United States
Name: Director Clinical Development
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR