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

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ClinicalTrials.gov Identifier: NCT00881569
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Drug: CS-7017 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: 1
Cs-7017 tablets twice daily at strength 0.25mg
Drug: CS-7017
CS-7017 tablets twice daily at strength 0.25mg




Primary Outcome Measures :
  1. Evaluate safety profile of CS-7017 treatment [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Determine the response, response duration and time to progression in cancer subjects [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881569


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

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00881569     History of Changes
Other Study ID Numbers: CS7017-A-U102E
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Efatutazone
Antineoplastic Agents