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Completed

NCT Number: NCT00881569

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

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.

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Key information

Conditions

Advanced Cancer

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

About this study

This is an open-label non-randomized 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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, 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.

Treatment and study plan

CS-7017

Drug

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

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

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

    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).

Secondary outcomes

  1. 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

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

    Duration of response was to be calculated as the date of progression minus the earliest date of complete response (CR) or partial response (PR), plus 1. The earliest date of CR or PR was to be taken from the earlier study (CS7017-A-U102). If any participant entered the study with stable disease (SD), then the duration of SD was to be calculated as the date of progression minus the date of first dose, plus 1. Time to progression was to be calculated as the date of progression minus the date of first dose of study medication in the earlier study, plus 1.

  2. 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

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

    Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. AE intensity was assessed according to the following scale: Mild (Grade 1), Awareness of sign or symptom, but easily tolerated, ie, does not interfere with subject's usual function; Moderate (Grade 2), Discomfort enough to cause interference with usual activity; Severe (Grade 3), Incapacitating with inability to work or do usual activity, ie, interferes significantly with participant's usual function. Severe (Grade 3) AEs indicate worse outcomes.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2009
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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