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

Completed · Phase 1

Conditions studied: Neoplasm

In brief

An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential cohorts of 3 to 6 participants with advanced or metastatic malignancies.

Key facts

Study ID

NCT00408434

Run by

Daiichi Sankyo

People needed

32

Starts

2006-11-01

Expected to finish

2010-02-01

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events 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 ejection fraction within normal range.

You may not qualify if…

• Anticipation of need for a major surgical procedure or radiation therapy during the study.
• Treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy, minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment start.
• Participants with clinically significant pleural or pericardial effusion (participants with minimal pleural effusion may be eligible at the Investigator's discretion).
• Clinically significant active infection, which requires antibiotic therapy, or human immunodeficiency virus (HIV)-positive participants receiving antiretroviral therapy.

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.