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

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 I

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

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 ]

Estimated Enrollment:	48
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CS-7017 from 0.05 to 3.2 mg bid	Drug: CS-7017 CS-7017 0.05 to 3.2 mg bid

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

Contacts


Contact: Ion Cotarla, MD, Ph.D.	202-687-4510	ic34@georgetown.edu

Contact: Julie A Pokela	617-632-6708	Julie_Pokela@dfci.harvard.edu

Locations


United States, District of Columbia
		Recruiting
	Washington, District of Columbia, United States

United States, Massachusetts
		Recruiting
	Boston, Massachusetts, United States

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators


Principal Investigator:	John Marshall, MD	Georgetown University

Principal Investigator:	George D Demetri, MD	Unaffiliated

More Information

Responsible Party:	Daiichi Sankyo ( Allison Gladden )
Study ID Numbers:	CS-7017-A-U102
First Received:	December 6, 2006
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00408434
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

PPARgamma agonist

advanced or metastatic malignancies

Tumor

Cancer

Study placed in the following topic categories:

Signs and Symptoms

Neoplasm Metastasis

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00408434