Previous Page  16 / 56 Next Page
Information
Show Menu
Previous Page 16 / 56 Next Page
Page Background

RAINBOW: Phase 3 Randomized Study in 2

nd

-line Gastric and GEJ Cancer, Ramucirumab with

Paclitaxel (CP12-0922/I4T-IE-JVBE)

Until

Progression

Patient Population

Gastric or GEJ adenocarcinoma (metastatic or locally advanced and unresectable)

1

st

-line therapy with platinum/fluoropyrimidine doublet, with or without anthracycline

Patient experienced progression during 1

st

-line therapy or within 4 months after 1

st

-line therapy

ECOG PS 0/1

No CNS metastases

Stratify by:

Time to progression on 1

st

-

line therapy

(< 6 vs ≥ 6 months)

Geographic region

Disease measurablility

(measurable vs.

nonmeasurable)

Ramucirumab 8 mg/kg every

2 weeks

+ Paclitaxel 80 mg/m

2

weekly

Placebo every 2 weeks

+ Paclitaxel 80 mg/m

2

weekly

N = 663

S

C

R

E

EN

R

A

N

D

O

M

I

Z

E

1:1

Tumor assessment every 6 weeks

Survival follow-up

Safety follow-u

p