Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	Pharmaceutical / Industry	CS7017-A-U103 NCT00603941

Trial Description

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Daiichi Sankyo, Incorporated

Director Clinical Development

Study Director

U.S.A.
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Brittany Hines	Ph: 720-848-0634
			Email: brittany.hines@uchsc.edu
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Carolyn Bieber	Ph: 904-953-6824
			Email: bieber.carolyn@mayo.edu
Massachusetts
	Boston
	Massachusetts General Hospital
		Patricia Ostler	Ph: 617-724-7829
			Email: postler@partners.org
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Jill Burton	Ph: 507-284-8440
			Email: burton@mayo.edu
Missouri
	St. Louis
		Donna Seckfort	Ph: 314-362-1334
			Email: DSeckfort@dom.wustl.edu
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Douglas Adkins, MD	Ph: 314-747-7402
			Email: dadkins@im.wustl.edu
Ohio
	Columbus
		Minden Collamore	Ph: 614-293-5413
			Email: Minden.Collamore@osumc.edu
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Manisha Shah, MD	Ph: 614-293-8629
			Email: manisha.shah@osumc.edu
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Susan Aust	Ph: 503-494-7702
			Email: austs@ohsu.edu
Pennsylvania
	Philadelphia
		Kethleen Harlacker, RN	Ph: 215-746-6344
			Email: kathleen.harlacker@uphs.upenn.edu
	University of Pennsylvania Maloney Hospital
		Marcia Brose	Ph: 215-746-6344
			Email: brosem@mail.med.upenn.edu
Tennessee
	Nashville
		Teresa Foster, RN	Ph: 615-936-1164
			Email: teresa.foster@Vanderbilt.edu
	Vanderbilt-Ingram Cancer Center
		Jill Gilbert, MD	Ph: 615-343-4677
			Email: jill.gilbert@Vanderbilt.edu
Virginia
	Norfolk
	Sentara Cancer Institute at Sentara Norfolk General Hospital
		Pam Kennedy, RN, BSN, OCN	Ph: 757-388-6238
			Email: kennedpw@evms.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00603941
Information obtained from ClinicalTrials.gov on October 25, 2009

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