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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00408434
First received: December 6, 2006
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Neoplasm
Drug: CS-7017
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Study of an Experimental New Drug, PPAR Agonist Taken by Mouth by Patients With Advanced or Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • To determine a RP2D for CS-7017 administered orally twice daily to patients with advanced or metastatic malignancies. [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To document the safety profile of CS-7017 administered orally twice daily; [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
  • To assess the PK of repeated oral doses of CS-7017 activity [ Time Frame: weekly for the first 4 weeks of treatment ] [ Designated as safety issue: No ]
  • To explore potential biomarkers of CS-7017 activity [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
  • To make preliminary assessments of the anti-tumor effects of CS-7107 administered twice daily [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-7017
CS-7017 from 0.05 to 3.2 mg bid
Drug: CS-7017
CS-7017 0.05mg and 1.0mg tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • ECOG performance status less than or equal to 2.
  • Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE 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 EF 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 TZDs, radiotherapy, minor surgery, or any investigational agent within 4 wks (6 wks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment start.
  • Patients with clinically significant pleural or pericardial effusion (patients with minimal pleural effusion may be eligible at the Investigator's discretion).
  • Clinically significant active infection, which requires antibiotic therapy, or HIV-positive patients receiving antiretroviral therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408434

Locations
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
Principal Investigator: John Marshall, MD Georgetown University
Principal Investigator: George D Demetri, MD
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allison Gladden, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00408434     History of Changes
Other Study ID Numbers: CS7017-A-U102
Study First Received: December 6, 2006
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
PPARgamma agonist
advanced or metastatic malignancies
Tumor
Cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014