RAINBOW trial overview
RAINBOW: The pivotal phase III trial for CYRAMZA in combination with 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
ECOG=Eastern Cooperative Oncology Group; PS=performance status.
Major Efficacy Outcome Measure: Overall survival
Supportive Efficacy Outcome Measures: Progression-free survival, objective 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 continue3
*75% of patients randomized in the study received prior platinum/fluoropyrimidine combination therapy without anthracycline; 25% received platinum/fluoropyrimidine combination therapy with anthracycline.
†Stratification factors were geographic region, time to progression on first-line therapy (<6 months vs ≥6 months), and disease measurability (measurable vs nonmeasurable disease).
Watch a presentation of the CYRAMZA clinical results