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Anti-metabolites

Study of MBP-426/leucovorin/5-FU for Stomach Cancer

Phase 1 & 2
Waitlist Available
Led By Jaffer A. Ajani, MD
Research Sponsored by Mebiopharm Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights

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.

Eligible Conditions
  • Stomach Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the dose of MBP-426 for use in the Phase II portion of this study of MBP-426 administered every 21 days in combination with leucovorin (folinic acid or FA) and fluorouracil (5-FU)
Secondary outcome measures
To characterize the safety profile of the combination therapy
To determine the plasma and urine pharmacokinetics of MBP-426 when given in combination with leucovorin and 5-FU
To undertake a preliminary exploration of anti-tumor activity of the combination therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study of MBP-426/leucovorin/5-FUExperimental Treatment1 Intervention
Study of MBP-426/leucovorin/5-FU. MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered ata 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.

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Who is running the clinical trial?

Mebiopharm Co., LtdLead Sponsor
1 Previous Clinical Trials
39 Total Patients Enrolled
Jaffer A. Ajani, MDPrincipal InvestigatorUT MD Anderson Cancer Center
6 Previous Clinical Trials
2,869 Total Patients Enrolled
~4 spots leftby Jun 2025
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