A Phase 1/2 Dose Finding Study of an Experimental New Drug CS7017, an Oral PPARγ Agonist Taken by Mouth Twice Daily in Combination With Paclitaxel Chemotherapy

Status:	Completed
Conditions:	Cancer, Cancer, Endocrine, Thyroid Cancer
Therapuetic Areas:	Endocrinology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	12/29/2018
Start Date:	January 2008
End Date:	December 2011

A Phase 1/2 Dose Finding Study of an Experimental New Drug CS7017, an Oral PPARγ Agonist Taken by Mouth Twice Daily in Combination With Paclitaxel Chemotherapy Administered Every Three Weeks by Venous Infusion by Patients With Anaplastic Thyroid Cancer

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.

During the Phase 1 and Phase 2 portions of the study, subject eligibility criteria are
identical except for prior treatment for ATC. During Phase 1, eligible subjects may have
received prior chemotherapy while during Phase 2, eligible subjects must be chemotherapy
naïve.

Inclusion Criteria:

- Histologically or cytologically diagnosed, advanced ATC

- Measurable lesion(s)

- Lesion(s) (primary or metastatic) with viable tumor tissue accessible for repeated
biopsy

- Age equal to or older than 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

- Adequate organ and bone marrow function

- Agreement to use effective contraception while on treatment and for equal to or
greater than 3 months after end of treatment

- Neither pregnant nor breastfeeding

Exclusion Criteria:

- No medical history of diabetes mellitus requiring treatment with insulin or oral
agents; no pleural or pericardial effusion or clinically significant pulmonary or
cardiovascular disease.

- No clinically active brain metastasis, uncontrolled seizure disorder, spinal cord
compression, or carcinomatous meningitis

- No clinically significant active infection requiring antibiotic or antiretroviral
therapy

- No concomitant use of other TZDs

We found this trial at

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200