Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Daiichi Sankyo Inc. |
---|---|
Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00603941 |
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.
Condition | Intervention | Phase |
---|---|---|
Anaplastic Thyroid Cancer |
Drug: CS7017 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 54 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: CS7017
At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.25, 0.35, and 0.50mg BID. At Phase 2, CS-7017 will be administered at the RP2D. Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
United States, Colorado | |
Univ of Colorado Cancer Center | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Brittany Hines 720-848-0634 brittany.hines@uchsc.edu | |
United States, Florida | |
Mayo Clinic | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Carolyn Bieber 904-953-6824 bieber.carolyn@mayo.edu | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Patricia Ostler 617-724-7829 postler@partners.org | |
Contact: Susan Symes 617-726-1849 ssymes@partners.org | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Jill Burton 507-284-8440 burton@mayo.edu | |
United States, Missouri | |
Washington University, Siteman Cancer Center | Recruiting |
St. Louis, Missouri, United States | |
Contact: Douglas Adkins, MD 314-747-7402 dadkins@im.wustl.edu | |
Contact: Donna Seckfort 314-362-1334 DSeckfort@dom.wustl.edu | |
United States, Ohio | |
Ohio State Univ | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Manisha Shah, MD 614-293-8629 manisha.shah@osumc.edu | |
Contact: Minden Collamore 614-293-5413 Minden.Collamore@osumc.edu | |
United States, Oregon | |
Oregon Health Science Univ | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Susan Aust 503-494-7702 austs@ohsu.edu | |
United States, Pennsylvania | |
University of Pennsylvania Maloney Hospital | Recruiting |
Philadelphia, Pennsylvania, United States | |
Contact: Marcia Brose 215-746-6344 brosem@mail.med.upenn.edu | |
Contact: Kethleen Harlacker, RN 215-746-6344 kathleen.harlacker@uphs.upenn.edu | |
United States, Tennessee | |
Vanderbilt Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States | |
Contact: Jill Gilbert, MD 615-343-4677 jill.gilbert@Vanderbilt.edu | |
Contact: Teresa Foster, RN 615-936-1164 teresa.foster@Vanderbilt.edu | |
United States, Virginia | |
Eastern Virginia Medical School | Recruiting |
Norfolk, Virginia, United States, 23507 | |
Contact: Pam Kennedy, RN, BSN, OCN 757-388-6238 kennedpw@evms.edu |
Study Director: | Director Clinical Development | Daiichi Sankyo Inc. |
Responsible Party: | Daiichi Sankyo, Inc. ( Slawek Wotjowicz-Praga, MD, Sr. Director, Clinical Development Oncology ) |
Study ID Numbers: | CS7017-A-U103 |
Study First Received: | January 15, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00603941 |
Health Authority: | United States: Food and Drug Administration |
Anaplastic Thyroid Cancer Neoplasm Tumor Anti-neoplastic Agent First-line treatment of advanced Anaplastic thyroid cancer |
Signs and Symptoms Thyroid Neoplasms Paclitaxel Head and Neck Neoplasms Endocrine System Diseases |
Endocrinopathy Thyroid cancer, anaplastic Thyroid Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |