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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Efatutazone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014