Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Completed · Phase 1
Conditions studied: Advanced Cancer
In brief
This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer administration of the agent.
Key facts
- Study ID
- NCT00881569
- Run by
- Daiichi Sankyo
- People needed
- 2
- Starts
- 2009-03-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2020-09-28
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participant previously treated with CS-7017 as part of a study that included CS-7017 and has shown clinical benefits from treatment with CS-7017.
You may not qualify if…
- Anticipation of need for a major surgical procedure or radiation therapy during the study.
- Any of the following conditions within 6 months prior to initiating study treatment: Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class II or higher congestive heart failure.
- Participants with clinically significant pleural or pericardial effusions.
- Clinically significant active infection, which requires antibiotic therapy, or human immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.
- Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction.
Where it is running
- Study site — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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