05-177
15 evidence topics · 3 sources
Objective
Antitumor activity on a continuous schedule
Location and study date
No evidence found.
Study design
Open-label phase 2 design
Eligibility criteria
Histologic diagnosis and suitability for standard therapy
Treatment
Summary
Participants were randomized to morning or evening administration of continuous daily sunitinib. This was a comparison of administration times, not of sunitinib against another drug.
Continuous daily dose
Study outcomes
Rationale for using clinical benefit rate as the primary endpoint
Summary
The primary clinical benefit rate combined complete responses, partial responses, and stable disease lasting at least 24 weeks.
Regulatory context for interpreting stable disease
Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets
Confidence interval accompanying the clinical benefit rate
Detailed analysis-set definitions
No evidence found.
Results
Participant disposition
Study completion
| Disposition | Participants |
|---|---|
| Completed the study | “26” |
Baseline characteristics
No evidence found.
Efficacy results
Continuous-dosing sunitinib study
Clinical benefit and overall survival
| Outcome | Value |
|---|---|
| Clinical benefit rate | “53%” |
| Median overall survival | “107 weeks” |
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Severity of most adverse events
Study limitations
Summary
The study treated 60 participants and was open-label. Randomization compared morning and evening dosing rather than continuous dosing against the intermittent schedule or against another therapy. The clinical benefit endpoint included prolonged stable disease, which is not equivalent to objective tumor response.