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:
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

January 15, 2008
February 6, 2013
January 2008
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00603941 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anaplastic Thyroid Cancer
  • 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
Experimental: 1
Interventions:
  • Drug: CS7017
  • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00603941
CS7017-A-U103
No
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Study Director: Director Clinical Development Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP