Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. Identifier:
First received: April 14, 2009
Last updated: September 5, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Drug: CS-7017
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Use of CS 7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Subjects With Cancer

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Evaluate safety profile of CS-7017 treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the response, response duration and time to progression in cancer subjects [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: March 2009
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cs-7017 tablets twice daily at strength 0.25mg
Drug: CS-7017
CS-7017 tablets twice daily at strength 0.25mg

Detailed Description:

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00881569

United States, District of Columbia
Washington, District of Columbia, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc. Identifier: NCT00881569     History of Changes
Other Study ID Numbers: CS7017-A-U102E
Study First Received: April 14, 2009
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration processed this record on March 03, 2015