Phase 2
Completed N=245
A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
Source: ClinicalTrials.gov NCT02514551 ↗Enrolled (actual)
245
Serious AEs
32.5%
Results posted
Dec 2018
Primary outcomePrimary: Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ — 5.42 months
Summary
The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ |
5.42 | — |
| SECONDARY Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ |
5.42; 5.16 | — |
| SECONDARY Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel |
39.2; 21.4; 63.6; 37.1; 76.7; 43.5 | — |
| SECONDARY Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) |
27.6; 25.4 | — |
| SECONDARY Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)] |
78.9; 75.4 | — |
| SECONDARY Number of Participants With Anti-Ramucirumab Antibodies |
2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has a diagnosis of gastric or GEJ adenocarcinoma.
- The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
- The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
- The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1.
- The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- The participant has adequate organ function:
- Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT 900 mg per meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin.
- The participant has documented brain metastases or leptomeningeal disease.
- The participant has a significant bleeding disorder or vasculitis.
- The participant experienced any arterial thromboembolic event within 6 months.
- The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia.
- The participant has uncontrolled hypertension, despite antihypertensive intervention.
- The participant underwent major surgery within 28 days.
- The participant has a history of gastrointestinal perforation or fistula within 6 months.
- The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.
- The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.
- The participant has either of the following:
- Child-pugh B or C cirrhosis.
- The participant has a serious illness or medical condition including:
- Human immunodeficiency virus infection.
- The participant has a concurrent active malignancy other than the following:
- Nonmelanomatous skin cancer.
- In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.
- The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture.
- The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.
Data sourced from ClinicalTrials.gov (NCT02514551). 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.