NCT00603941

A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel in Subjects With Advanced Anaplastic Thyroid Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anaplastic Thyroid Cancer

Interventions

Type	Name	Description
DRUG	CS-7017	At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.30, or 0.50 mg BID. At Phase 2, CS-7017 will be administered at the recommended phase 2 dose (RP2D).
DRUG	Paclitaxel	Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-01-29
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

10 sites across 1 country: United States