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 |
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.
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.
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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