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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00881569
First received: April 14, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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
Cancer
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

Resource links provided by NLM:


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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881569

Locations
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.
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on October 20, 2014