Study of an Experimental New Drug, PPAR Agonist Taken by Mouth by Patients 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. Identifier: NCT00408434
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : February 15, 2010
Information provided by:
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 patients with advanced or metastatic malignancies.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
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, PPAR Agonist Taken by Mouth by Patients With Advanced or Metastatic Cancer
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. To determine a RP2D for CS-7017 administered orally twice daily to patients with advanced or metastatic malignancies. [ Time Frame: 6 to 12 months ]

Secondary Outcome Measures :
  1. To document the safety profile of CS-7017 administered orally twice daily; [ Time Frame: 6 to 12 months ]
  2. To assess the PK of repeated oral doses of CS-7017 activity [ Time Frame: weekly for the first 4 weeks of treatment ]
  3. To explore potential biomarkers of CS-7017 activity [ Time Frame: 6 to 12 months ]
  4. To make preliminary assessments of the anti-tumor effects of CS-7107 administered twice daily [ Time Frame: 6 to 12 months ]

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

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.

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 identifier (NCT number): NCT00408434

United States, District of Columbia
Washington, District of Columbia, United States
United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Principal Investigator: John Marshall, MD Georgetown University
Principal Investigator: George D Demetri, MD

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Allison Gladden, Daiichi Sankyo Identifier: NCT00408434     History of Changes
Other Study ID Numbers: CS7017-A-U102
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents