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

Daiichi Sankyo

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: CS-7017

Study type

Interventional

Funder types

Industry

Identifiers

NCT00881569

CS7017-A-U102E

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2 patients

Sex

All

Volunteers

No Healthy Volunteers

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.