Status:
COMPLETED
Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
Lead Sponsor:
Daiichi Sankyo
Conditions:
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00408434
Start Date
November 1 2006
End Date
February 1 2010
Last Update
October 19 2020
Active Locations (2)
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1
Washington D.C., District of Columbia, United States
2
Boston, Massachusetts, United States