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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:November 2006
End Date:February 2010

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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

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.


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.
We found this trial at
2
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