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 - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by (Responsible Party):	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00603941

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	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:

MedlinePlus related topics: Cancer Thyroid Cancer Thyroid Diseases

Drug Information available for: Paclitaxel

U.S. FDA Resources

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 ]

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
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.

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:	August 29, 2011
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 22, 2012