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Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma

NCT00964080 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2014-12-02

No results posted yet for this study

Summary

The ongoing study is a Phase II, open-label study to evaluate the efficacy of MBP-426 at a dose of 170 mg/m2 in combination therapy in patients with second line metastatic gastric, gastro-esophageal junction or esophageal adenocarcinoma.

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Adenocarcinoma

Interventions

DRUG

MBP-426/Leucovorin/5-FU

MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered at a dose of 400 mg/m2 after the MBP-426 infusion and in the absence of allergy/infusion reaction. 5-FU is administered concurrently with the leucovorin infusion and after the MBP-426 administration as a 46-hour continuous infusion of 2400 mg/m2.

Sponsors & Collaborators

  • Mebiopharm Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jaffer A. Ajani, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-10-31
Completion
2015-04-30

Countries

  • United States
  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00964080 on ClinicalTrials.gov