drugset / Trial / NCT00603941

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

NCT00603941

Phase 1/2 Terminated 19 enrolled Daiichi Sankyo
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2008-01
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 135 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject efatutazone Small molecule 0.15 mg Oral
Subject efatutazone Small molecule 0.3 mg Oral
Subject efatutazone Small molecule 0.5 mg Oral