Phase 1
Completed N=2
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Source: ClinicalTrials.gov NCT00881569 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer — 0; 1; 1; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer |
0; 1; 1; 0 | — |
| SECONDARY 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 |
NA; 441; 337; 686; 337; NA | — |
| SECONDARY 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 |
0; 1; 0; 1; 0; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00881569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.