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A Phase I Dose Finding Study of an Experimental New Drug, PPAR Agonist Taken by Mouth by Patients With Advanced or Metastatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasm

Thank you

Trial Information

A Phase I Dose Finding Study of an Experimental New Drug, PPAR Agonist Taken by Mouth by Patients With Advanced or Metastatic Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine a RP2D for CS-7017 administered orally twice daily to patients with advanced or metastatic malignancies.

Outcome Time Frame:

6 to 12 months

Safety Issue:

No

Principal Investigator

John Marshall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Food and Drug Administration

Study ID:

CS7017-A-U102

NCT ID:

NCT00408434

Start Date:

November 2006

Completion Date:

February 2010

Related Keywords:

  • Neoplasm
  • PPARgamma agonist
  • advanced or metastatic malignancies
  • Tumor
  • Cancer
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Boston, Massachusetts  
Washington, District of Columbia