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


Phase 1
N/A
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate safety profile of CS-7017 treatment

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CS7017-A-U102E

NCT ID:

NCT00881569

Start Date:

March 2009

Completion Date:

September 2011

Related Keywords:

  • Cancer

Name

Location

Washington, District of Columbia