Status:
COMPLETED
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Lead Sponsor:
Daiichi Sankyo
Conditions:
Advanced Cancer
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 treat...
Detailed Description
This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00881569
Start Date
March 1 2009
End Date
September 1 2011
Last Update
September 28 2020
Active Locations (1)
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1
Washington D.C., District of Columbia, United States