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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
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase II, Phase I
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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CS7017-A-U103
NCT00603941
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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. - Histologically or cytologically diagnosed, advanced ATC
- 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
- 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 |
Trial Sites
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| U.S.A. |
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| Colorado |
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Aurora |
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| | | | | | | | | University of Colorado Cancer Center at UC Health Sciences Center |
| | | Brittany Hines |
Ph: 720-848-0634 |
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Email:
brittany.hines@uchsc.edu |
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| Florida |
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Jacksonville |
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| | | | Mayo Clinic - Jacksonville |
| | | Carolyn Bieber |
Ph: 904-953-6824 |
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Email:
bieber.carolyn@mayo.edu |
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| Massachusetts |
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Boston |
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| | | | Massachusetts General Hospital |
| | | Patricia Osteer |
Ph: 617-724-7829 |
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Email:
postler@partners.org |
| | | Susan Symes |
Ph: 617-726-1849 |
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Email:
ssymes@partners.org |
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| Minnesota |
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Rochester |
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| | | | Mayo Clinic Cancer Center |
| | | Jill Burton |
Ph: 507-284-8440 |
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| Ohio |
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Columbus |
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| | | | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| | | Manisha Shah, MD |
Ph: 614-293-8629 |
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Email:
manisha.shah@osumc.edu |
| | | Minden Collamore |
Ph: 614-293-5413 |
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Email:
Minden.Collamore@osumc.edu |
| | | Manisha Shah, MD | Principal Investigator |
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| Oregon |
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Portland |
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| | | | Oregon Health and Science University Cancer Institute |
| | | Erin Neal |
Ph: 503-494-7702 |
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Email:
neale@ohsu.edu |
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| Virginia |
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Norfolk |
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| | | | Sentara Cancer Institute at Sentara Norfolk General Hospital |
| | | Pam Kennedy, RN, BSN, OCN |
Ph: 757-388-2788 |
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Email:
pwkenned@sentara.com |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00603941
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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