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A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

Primary Purpose

Anaplastic Thyroid Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CS-7017
Paclitaxel
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Thyroid Cancer focused on measuring Anaplastic Thyroid Cancer, Neoplasm, Tumor, Anti-neoplastic Agent, First-line treatment of advanced Anaplastic thyroid cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

During the Phase 1 and Phase 2 portions of the study, participant eligibility criteria are identical except for prior treatment for anaplastic thyroid cancer (ATC). During Phase 1, eligible participants may have received prior chemotherapy while during Phase 2, eligible participants 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
  • Pregnant or breastfeeding

Exclusion Criteria:

  • Medical history of diabetes mellitus requiring treatment with insulin or oral agents; no pleural or pericardial effusion or clinically significant pulmonary or cardiovascular disease.
  • Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
  • Clinically significant active infection requiring antibiotic or antiretroviral therapy
  • Concomitant use of other thiazolidinediones (TZDs)

Sites / Locations

  • Univ of Colorado Cancer Center
  • Mayo Clinic
  • Massachusetts General Hospital
  • Mayo Clinic
  • Washington University, Siteman Cancer Center
  • Ohio State Univ
  • Oregon Health Science Univ
  • University of Pennsylvania Maloney Hospital
  • Vanderbilt Ingram Cancer Center
  • Eastern Virginia Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1; 0.15 mg CS-7017

Cohort 2; 0.30 mg CS-7017

Cohort 3; 0.50 mg CS-7017

Arm Description

Participants who received 0.15 mg twice daily (BID) oral CS-7017 and 135 [Dose Level 1a] or 175 [Dose Level 1b] mg/m^2 intravenous (IV) paclitaxel once every 3 weeks.

Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.

Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.

Outcomes

Primary Outcome Measures

Overall Progression-free Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.
Overall Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
Overall survival (OS) was defined as the time from the date enrollment to the date of death.
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
The best overall response was the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no tumor assessment after the date of enrollment, the best overall response is classified as Unknown.

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
Treatment-emergent adverse events (TEAEs) are defined as adverse events that started or worsened after the first dose of any study drug (after Day 1 or first day of CS-7017 monotherapy) but adverse events occurring more than 30 days after the last dose are not considered TEAEs unless also considered to be related (possibly, probably, or definitely) to study drug.

Full Information

First Posted
January 15, 2008
Last Updated
August 31, 2020
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00603941
Brief Title
A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel
Official Title
A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel in Subjects With Advanced Anaplastic Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to low enrollment, no participant had a dose limiting toxicity, therefore a maximum tolerated dose could not be established
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Thyroid Cancer
Keywords
Anaplastic Thyroid Cancer, Neoplasm, Tumor, Anti-neoplastic Agent, First-line treatment of advanced Anaplastic thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1; 0.15 mg CS-7017
Arm Type
Experimental
Arm Description
Participants who received 0.15 mg twice daily (BID) oral CS-7017 and 135 [Dose Level 1a] or 175 [Dose Level 1b] mg/m^2 intravenous (IV) paclitaxel once every 3 weeks.
Arm Title
Cohort 2; 0.30 mg CS-7017
Arm Type
Experimental
Arm Description
Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
Arm Title
Cohort 3; 0.50 mg CS-7017
Arm Type
Experimental
Arm Description
Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m^2 IV paclitaxel once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
CS-7017
Intervention Description
At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.30, or 0.50 mg BID. At Phase 2, CS-7017 will be administered at the recommended phase 2 dose (RP2D).
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.
Primary Outcome Measure Information:
Title
Overall Progression-free Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
Description
Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.
Time Frame
From baseline up to disease progression or death, up to approximately 2 years postdose
Title
Overall Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
Description
Overall survival (OS) was defined as the time from the date enrollment to the date of death.
Time Frame
From baseline up to date of death, up to approximately 2 years postdose
Title
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
Description
The best overall response was the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no tumor assessment after the date of enrollment, the best overall response is classified as Unknown.
Time Frame
From baseline up to disease progression or the development of unacceptable toxicity, up to approximately 2 years postdose
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC)
Description
Treatment-emergent adverse events (TEAEs) are defined as adverse events that started or worsened after the first dose of any study drug (after Day 1 or first day of CS-7017 monotherapy) but adverse events occurring more than 30 days after the last dose are not considered TEAEs unless also considered to be related (possibly, probably, or definitely) to study drug.
Time Frame
From baseline up to 30 days after last dose, up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
During the Phase 1 and Phase 2 portions of the study, participant eligibility criteria are identical except for prior treatment for anaplastic thyroid cancer (ATC). During Phase 1, eligible participants may have received prior chemotherapy while during Phase 2, eligible participants 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 Pregnant or breastfeeding Exclusion Criteria: Medical history of diabetes mellitus requiring treatment with insulin or oral agents; no pleural or pericardial effusion or clinically significant pulmonary or cardiovascular disease. Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis Clinically significant active infection requiring antibiotic or antiretroviral therapy Concomitant use of other thiazolidinediones (TZDs)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director Clinical Development
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Univ of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University, Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Ohio State Univ
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health Science Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania Maloney Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

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