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

Trial schematic

ECOG=Eastern Cooperative Oncology Group; PS=performance status.

Major Efficacy Outcome Measure: Overall survival (OS)

Supportive Efficacy Outcome Measures: Progression-free survival (PFS), objective response rate (ORR)

  • 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).

References:
  1. CYRAMZA (ramucirumab) [package insert]. India, Eli Lilly & Company (India) Pvt. Ltd.
  2. Wilke H, Muro K, Van Cutsem E, et al; for the RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224‐1235.
  3. Supplement to: Wilke H, Muro K, Van Cutsem E, et al; for the RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235.
Top