Extended Use Protocol for Subjects With Cancer to Receive Continued Treatment With CS-7017



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:12/23/2018
Start Date:March 2009
End Date:September 2011

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Extended Use of CS 7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Subjects With Cancer

This is a study of CS-7017 designed to allow subjects who completed participation in a
clinical study of CS 7017 without experiencing disease progression or unacceptable toxicity
to continue treatment with study drug. Subjects who have not progressed while receiving
CS-7017 will continue to benefit from longer administration of the agent.

This is an open-label non-randomized study of CS7017 designed to allow subjects who completed
participation in a clinical study of CS7017 without experiencing disease progression or
unacceptable toxicity to continue treatment with study drug.

Inclusion Criteria:

- Subject previously treated with CS7017 as part of a study that included CS7017 and has
shown clinical benefits from treatment with CS-7017.

Exclusion Criteria:

- 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, NYHA class II or higher congestive heart failure.

- Subjects with clinically significant pleural or pericardial effusions.

- Clinically significant active infection, which requires antibiotic therapy, or
HIV-positive subjects receiving antiretroviral therapy.

- Subjects with diabetes mellitus requiring treatment with insulin, sulfonylureas or
TZDs agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or
partial bowel obstruction.
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