MM-398 and Ramucirumab in Treating Patients With Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Gastric Adenocarcinoma Clinical Trial

Official title: Phase I/II Study of MM-398 in Combination With Ramucirumab After Platinum Failure in Gastric Cancer

Status Withdrawn

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of MM-398 and ramucirumab in treating patients with gastric cancer or gastroesophageal junction adenocarcinoma. MM-398 contains a chemotherapy drug called irinotecan, which in its active form interrupts cell reproduction. MM-398 builds irinotecan into a container called a liposome which may be able to release the medicine slowly over time to reduce side effects and increase its ability to kill tumor cells. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving MM-398 and ramucirumab together may work better in treating patients with gastric cancer or gastroesophageal junction adenocarcinoma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Phase I portion is to determine the recommended phase II dose (RP2D) of liposomal irinotecan (MM-398) when given in combination with ramucirumab at 8 mg/kg every 2 weeks in patients with gastric and gastroesophageal adenocarcinoma (GEAC) who had failed or are intolerant of platinum-based therapy.

II. Phase II portion is to assess the preliminary efficacy and tolerability of MM-398 in combination with ramucirumab in patients with GEAC who had failed or are intolerant of platinum based therapy.

SECONDARY OBJECTIVES:

I. To estimate the best overall response rate through up to three cycles of therapy among patients with measurable disease at study entry.

II. To assess the incidence and severity of toxicity of the combination.

EXPLORATORY OBJECTIVES:

I. Descriptive of quality of life domains using Patient-Reported Outcomes Measurement Information System (PROMIS) global health instrument (PRO).

II. Descriptive of altered genes on liquid biopsies. III. To assess the effect of the anti-angiogenic ramucirumab on distribution of MM-398 via magnetic resonance imaging (MRI) with and without ferumoxytol.

OUTLINE: This is a phase I, dose escalation study of MM-398followed by a phase II study.

Patients receive ramucirumab intravenously (IV) over 30 minutes and MM-398 IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 6 months. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Locally Advanced Unresectable Gastric Adenocarcinoma
• Metastatic Gastroesophageal Junction Adenocarcinoma
• Metastatic Unresectable Gastric Adenocarcinoma
• Unresectable Gastroesophageal Junction Adenocarcinoma

• NCT number: NCT03739801
• Study type: Interventional
• Source: University of Southern California
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: April 6, 2020
• Completion date: April 6, 2023