Phase 3
Completed N=665
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
Source: ClinicalTrials.gov NCT01170663 ↗Enrolled (actual)
665
Serious AEs
46.8%
Results posted
Jul 2014
Primary outcomePrimary: Overall Survival Time (OS) — 9.6; 7.4 months — p=0.0169
Summary
This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Time (OS) |
9.6; 7.4 | 0.0169 sig |
| SECONDARY Progression-Free Survival (PFS) |
4.4; 2.9 | <0.0001 sig |
| SECONDARY Time to Progressive Disease (TTP) |
5.52; 3.02 | <0.0001 sig |
| SECONDARY Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD |
0.6; 0.3; 27.3; 15.8; 52.1; 47.5 | — |
| SECONDARY Percentage of Participants With CR or PR (Objective Response Rate [ORR]) |
27.9; 16.1 | 0.0001 sig |
| SECONDARY Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity) |
1.6; 0.3 | — |
| SECONDARY Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion |
146 | — |
| SECONDARY Cmax After 4th Ramucirumab (IMC-1211B) Infusion |
193 | — |
| SECONDARY Cmax After 7th Ramucirumab (IMC-1211B) Infusion |
216 | — |
| SECONDARY Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion |
— | — |
| SECONDARY Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion |
45.0 | — |
| SECONDARY Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion |
62.8 | — |
| SECONDARY Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status |
-13.5; -12.1 | 0.3973 |
| SECONDARY Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score |
-0.16; -0.19 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Metastatic disease or locally advanced, unresectable disease
- Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
- Organs are functioning well (liver, kidney, blood)
- Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
Exclusion Criteria
- First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
- Previous systemic therapy with other anti-angiogenic drugs
- Uncontrolled high blood pressure
- Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
- Evidence of central nervous system (CNS) metastasis at baseline
Data sourced from ClinicalTrials.gov (NCT01170663). 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.