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

Daiichi Sankyo

Status and phase

Completed

Phase 1

Conditions

Neoplasm

Treatments

Drug: CS-7017

Study type

Interventional

Funder types

Industry

Identifiers

NCT00408434

CS7017-A-U102

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
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 criteria

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.