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Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00408434
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential cohorts of 3 to 6 participants with advanced or metastatic malignancies.

Condition or disease Intervention/treatment Phase
Neoplasm Drug: CS-7017 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Patients With Advanced or Malignancies
Study Start Date : November 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: CS-7017
CS-7017 from 0.05 to 3.2 mg bid
Drug: CS-7017
CS-7017 0.05mg and 1.0mg tablets




Primary Outcome Measures :
  1. Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies [ Time Frame: Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 months ]
    Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). Objective response rate was defined as the sum of all CRs and PRs.


Secondary Outcome Measures :
  1. Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies [ Time Frame: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. ]
    Area under the plasma/serum drug concentration-time curve for dosing interval (AUC[0-tau]), computed using the linear trapezoidal rule and area under the plasma/serum drug concentration-time curve from 0 to last time point above the quantification limit (AUC[0-t]) calculated using the linear trapezoidal rule were assessed.

  2. Summary of Pharmacokinetic Parameter Observed Maximum Plasma Concentration (Cmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies [ Time Frame: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. ]
    Cmax was defined as observed maximum plasma concentration.

  3. Summary of Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies [ Time Frame: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. ]
  4. Summary of Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies [ Time Frame: Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. ]
    Tmax was defined as time of maximum plasma concentration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically diagnosed advanced or metastatic malignancy that is refractory to, not curable with, or not eligible for standard treatment(s).
  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
  • Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grade less than or equal to 1.
  • Adequate organ and bone marrow function.
  • Willing to use effective contraceptive while on treatment through at least 3 months thereafter.
  • Negative pregnancy test for females of childbearing potential.
  • Echocardiogram with ejection fraction within normal range.

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or radiation therapy during the study.
  • Treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy, minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment start.
  • Participants with clinically significant pleural or pericardial effusion (participants with minimal pleural effusion may be eligible at the Investigator's discretion).
  • Clinically significant active infection, which requires antibiotic therapy, or human immunodeficiency virus (HIV)-positive participants receiving antiretroviral therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408434


Locations
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United States, District of Columbia
Washington, District of Columbia, United States
United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Study Clinical Lead Daiichi Sankyo, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00408434    
Other Study ID Numbers: CS7017-A-U102
First Posted: December 7, 2006    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc.:
PPARγ agonist
advanced or metastatic malignancies
Tumor
Cancer
Additional relevant MeSH terms:
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Efatutazone
Antineoplastic Agents