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RAINBOW: Study Design

Treat until

disease

progression or

intolerable

toxicity

Ramucirumab 8 mg/kg day 1&15

+ Paclitaxel 80 mg/m

2

day 1,8 &15

of a 28-day cycle

N = 330

Placebo day 1&15

+ Paclitaxel 80 mg/m

2

day 1,8 &15

N = 335

R

A

N

D

O

M

I

Z

E

Survival and

safety follow-up

1:1

S

C

R

E

EN

Important inclusion criteria:

-

Metastatic or loc. adv. unresectable gastric or GEJ* adenocarcinoma

- Progression after 1

st

line platinum/fluoropyrimidine based chemotherapy

Stratification factors

:

-

Geographic region,

- Measurable vs non-measurable disease,

- Time to progression on 1

st

line therapy (< 6 mos vs. ≥ 6 mos)

OS