Advanced or metastatic gastric or GEJ adenocarcinoma
Clinical trial design: RAINBOW
RAINBOW: The pivotal phase III trial for CYRAMZA + paclitaxel (N=665)1-3
A large, multicenter, randomized, double-blind trial of locally advanced or metastatic gastric or GEJ adenocarcinoma patients previously treated with fluoropyrimidine-and platinum-containing chemotherapy*
RAINBOW TRIAL DESIGN1-3
Major Efficacy Outcome Measure: Overall survival.
Supportive Efficacy Outcome Measures: Progression-free survival, overall response rate.
- Patients received treatment until disease progression or unacceptable toxicity2.
- If one study agent (either CYRAMZA/placebo or paclitaxel) was discontinued as a result of toxicity, then treatment with the other study agent was allowed to continue.3
RAINBOW: Demographic and baseline characteristics were similar between treatment arms1,2
RAINBOW: Demographic and baseline characteristics1,2
RAINBOW: Treatment administered prior to enrollment included a number of different regimens5
RAINBOW: Prior chemotherapy regimens across treatment arms5
- 39 patients received trastuzumab as part of an anticancer treatment regimen prior to the study (20 patients in the CYRAMZA + paclitaxel arm vs 19 patients in the placebo + paclitaxel arm)6