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

NCT00881569 | Completed Phase 1 Results

• 1 other identifier: CS7017-A-U102E
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer administration of the agent.

Conditions

Advanced Cancer

Keywords

CS-7017; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer

  At each evaluation, the participant's status was assessed as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD); the best response was then identified. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).

  From baseline and every 6 weeks postdose, up to 2 years 6 months

Secondary Outcomes (2)

• Response/Stable Disease Duration and Time to Progression Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer

  Baseline and every 6 weeks postdose, up to 2 years 6 months

• Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer

  Baseline up to 30 days after last dose, up to 2 years 6 months

Study Arms (1)

1

EXPERIMENTAL

CS-7017 tablets twice daily at strength ranging from 0.5 mg to 0.75 mg

Drug: CS-7017

Interventions

CS-7017 DRUG

CS-7017 administered orally, twice daily continuously for 6 weeks

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant previously treated with CS-7017 as part of a study that included CS-7017 and has shown clinical benefits from treatment with CS-7017.

You may not qualify if:

• 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, New York Heart Association (NYHA) class II or higher congestive heart failure.
• Participants with clinically significant pleural or pericardial effusions.
• Clinically significant active infection, which requires antibiotic therapy, or human immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.
• Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Unknown Facility

Washington D.C., District of Columbia, United States

Location

MeSH Terms

Interventions

efatutazone

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 28, 2020
• Results First Posted: August 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (1)