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
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00603941
First received: January 15, 2008
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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 Drug: Paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- To determine the Phase 2 dose for CS-7017 co-administered with paclitaxel in subjects with advanced Anaplastic thyroid cancer [ Time Frame: until disease progression or the development of unacceptable toxicity ] [ Designated as safety issue: No ]
- To determine overall progression-free survival in combination with paclitaxel in subjects with advanced ATC [ Time Frame: until disease progression or the development of unacceptable toxicity ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety profile of the combination of CS7017 and paclitaxel [ Time Frame: treatment continues until disease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
- To determine the PK of CS7017 [ Time Frame: treatment continues until disease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
- To determine the objective response rate [ Time Frame: treatment continues until disease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
- To determine overall survival and median survival time [ Time Frame: treatment continues until disease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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.
Drug: Paclitaxel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603941
Locations
| United States, Colorado | |
| Univ of Colorado Cancer Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University, Siteman Cancer Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Ohio State Univ | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health Science Univ | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pennsylvania Maloney Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Vanderbilt Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Virginia | |
| Eastern Virginia Medical School | |
| Norfolk, Virginia, United States, 23507 | |
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
| Study Director: | Director Clinical Development | Daiichi Sankyo Inc. |
More Information
No publications provided
| Responsible Party: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00603941 History of Changes |
| Other Study ID Numbers: | CS7017-A-U103 |
| Study First Received: | January 15, 2008 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Daiichi Sankyo Inc.:
|
Anaplastic Thyroid Cancer Neoplasm Tumor Anti-neoplastic Agent First-line treatment of advanced Anaplastic thyroid cancer |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Endocrine System Diseases Antineoplastic Agents |
Paclitaxel Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013