Phase 3
Completed N=440
A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer
Source: ClinicalTrials.gov NCT02898077 ↗Enrolled (actual)
440
Serious AEs
31.3%
Results posted
Aug 2021
Primary outcomePrimary: Progression Free Survival (PFS) — 4.14; 3.15 Months — p=0.0184
◆ Published Evidence
Established
93citations · ~19 / year
Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial.
Summary
The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.
Linked Publications
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Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
4.14; 3.15 | 0.0184 sig |
| PRIMARY Overall Survival (OS) |
8.71; 7.92 | — |
| SECONDARY Time to Progression (TTP) |
4.27; 4.07 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
26.5; 21.9 | — |
| SECONDARY Duration of Objective Response (DoR) |
4.34; 2.83 | — |
| SECONDARY Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
5.30; 8.43; 1.09; 1.20; 0.60; 1.27 | — |
| SECONDARY Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
-14.42; -9.83; -14.31; -11.71; -18.46; -14.39 | — |
| SECONDARY Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score |
-0.1351; -0.1303 | — |
| SECONDARY Change From Baseline in Participant-Reported EQ-5D-3L Visual Analog Scale (VAS) Score |
-9.6; -8.6 | — |
Eligibility Criteria
Inclusion Criteria
- Have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 or 1 at study entry.
- Have a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- Have metastatic disease or locally advanced, unresectable disease.
- Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
- Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet for unresectable or metastatic disease.
- Have adequate organ function.
- Have urinary protein ≤1+ on dipstick or routine urinalysis.
Exclusion Criteria
- Have undergone major surgery within 28 days prior to randomization.
- Have received any first-line chemotherapy other than platinum and fluoropyrimidine with or without anthracycline for advanced gastric or GEJ adenocarcinoma.
- Have received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.
- Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to randomization.
- Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry.
- Have a history of GI perforation and/or fistulae within 6 months prior to randomization.
- Have experienced any arterial thromboembolic event within 6 months prior to randomization.
- Have uncontrolled arterial hypertension (systolic blood pressure ≥160 millimeters of mercury [mmHg] or diastolic blood pressure ≥100 mmHg) despite standard medical management.
- Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
- Have a serious illness or medical condition(s).
Data sourced from ClinicalTrials.gov (NCT02898077) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.