Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial
Phase 3N = 312NCT00075218
- Population
- Patients with advanced GIST resistant to or intolerant of imatinib
- Design
- Randomised (2:1), double-blind, placebo-controlled, multicentre international trial. Sunitinib or placebo once daily at a 50 mg starting dose in 6-week cycles (4 weeks on, 2 weeks off). Unblinded early after a planned interim analysis showed significantly longer time to tumour progression with sunitinib.
- Primary endpoint
- TTP
- Arms
- Sunitinib (experimental, n = 207): Sunitinib 50 mg daily, 4 weeks on / 2 weeks off
- Placebo (control, n = 105): Placebo daily
- People
- Demetri GD, Pfizer
TTPHR 0.33
Show the numbers
| Endpoint | Analysis | Sunitinib | Placebo | Effect |
|---|---|---|---|---|
| TTPThe abstract names intention-to-treat, modified intention-to-treat and per-protocol analyses but does not say which one this figure comes from | interimDemetri 2006 | — | — | HR 0.33P<0.0001Median time to tumour progression is published in weeks: 27.3 weeks (95% CI 16.0 to 32.1) with sunitinib vs 6.4 weeks (4.4 to 10.0) with placebo. Weeks are kept as published (the schema's median field takes months or years). |
| Endpoint | Analysis | Sunitinib | Placebo | Effect |
|---|---|---|---|---|
| TTPThe abstract names intention-to-treat, modified intention-to-treat and per-protocol analyses but does not say which one this figure comes from | interimDemetri 2006 | — | — | HR 0.33P<0.0001Median time to tumour progression is published in weeks: 27.3 weeks (95% CI 16.0 to 32.1) with sunitinib vs 6.4 weeks (4.4 to 10.0) with placebo. Weeks are kept as published (the schema's median field takes months or years). |