Phase 3
N=355
Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
Gastric Cancer · Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00917384 ↗Enrolled (actual)
355
Serious AEs
46.4%
Results posted
Oct 2014
Primary outcome: Primary: Overall Survival (OS) — 5.2; 3.8 months — p=0.0473
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ramucirumab (Biological); Placebo (Drug); Best Supportive Care (BSC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
5.2; 3.8 | 0.0473 sig |
| SECONDARY Progression-Free Survival (PFS) |
2.1; 1.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate) |
40.1; 15.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Objective Response (Objective Response Rate [ORR]) |
3.4; 2.6 | — |
| SECONDARY Duration of Response (DOR) |
— | — |
| SECONDARY Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30) |
2.42; 0.80; -6.26; -12.01; -4.32; -11.79 | — |
| SECONDARY Number of Participants With Adverse Events |
112; 51; 213; 91 | — |
| SECONDARY Maximum Concentration (Cmax) of IMC-1121B |
— | — |
| SECONDARY Number of Participants Who Developed Antibodies Against IMC-1121B |
6; 1 | — |
Summary
The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma
- Metastatic disease or locally recurrent, unresectable disease with measurable lymph node metastases
- Measurable disease and/or evaluable disease. Measurable disease is defined as at least one unidimensionally-measurable target lesion [≥ 2 centimeter (cm) with conventional techniques or ≥ 1 cm by spiral computed tomography (CT)], as defined by Response using Response Evaluation Criteria in Solid Tumors (RECIST).
Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST
- Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
- Disease is not amenable to potentially curative resection
- Participant is ≥ 18 years of age
- Participant has a life expectancy of ≥ 12 weeks
- Participant resolution to Grade ≤ 1 (or to Grade ≤ 2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1
- The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 milligrams/deciliter (mg/dL) [25.65 micromole/liter (µmol/L)], and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x the upper limit of normal (ULN) [or 5.0 x the ULN in the setting of liver metastases]
- The participant has adequate renal function as defined by a serum creatinine ≤ 1.5 x the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥ 40 milliliters/minute (mL/min) (that is, if serum creatinine is > 1.5 x the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)
- The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate 3 years
Data sourced from ClinicalTrials.gov (NCT00917384). 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.