Phase 1b Study of Ramucirumab in Combination With Fluoropyrimidines and Platinum-Based Agents in Japanese Patients With Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Phase 1

• Conditions: Stomach Neoplasms

• Registration Number: JPRN-jRCT2080222764
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

A histopathologically or cytologically confirmed diagnosis of gastric or GEJ adenocarcinoma which is metastatic or locally advanced and unresectable. A participant with esophageal cancer is not eligible.
-Not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. Participants whose disease has progressed after >6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
-Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
-Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment.
-The participant has adequate organ function.
-Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version [v]4.03) of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer.
-Female participants of childbearing potential must have a negative serum or urinary pregnancy.
-Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Exclusion Criteria

-A significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment.
-Uncontrolled arterial hypertension, despite standard medical management.
-A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment.
-Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment.
-Radiation therapy within 14 days prior to enrollment.
-Received any previous systemic therapy (including investigational agents) targeting VEGF (vascular endothelial growth factor) or the VEGF receptor signaling pathways.
-Cirrhosis at a level of Child-Pugh B (or worse); or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
-A serious illness or medical condition(s).
-Pregnant or breastfeeding.
-Dysphagia for oral medication.
-Known allergy or hypersensitivity to any study treatment.
-Human epidermal growth factor receptor (HER) 2 status of positive.
-Received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device.

Study & Design

• Study Type: Interventional
• Study Design: Not specified