A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer

• Status: Completed
• Trial end date: 2018-12-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Paclitaxel; Ramucirumab

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 <5 × ULN.

• Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute.

• Urinary protein is <2+.

• Absolute neutrophil count ≥1.5 × 10^9/liter (L), platelets ≥100 × 10^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).

• International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN.

• The participant has an estimated life expectancy of minimum 12 weeks.

• The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy.

• The participant, if male, is sterile or agrees to use a reliable method of birth control.

• The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.

• The participant, if female and of child-bearing potential, must have a negative pregnancy test.

Exclusion Criteria:

• The participant is receiving therapy with any of the following:

• Nonsteroidal anti-inflammatory agents.

• Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted.

• The participant received radiotherapy within 14 days prior to randomization.

• The participant received previous chemotherapy with a cumulative dose of >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.