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.
This study will start with a Phase Ib portion, at a dose of 226 mg/m2, a dose in which good tolerability was demonstrated in the Phase I trial. A cohort may be enrolled at 301 mg/m2, if 226 mg/m2 is well tolerated. The dose determined from the Phase Ib portion of the study will then be evaluated in the Phase II portion. This design will permit evaluation of a true positive or negative response while limiting over exposure of patients to the study drug. If this regimen does offer a positive response, its reduced toxicity and potentially greater efficacy may yield better outcomes for patients requiring second-line therapy for UGI cancer. Following completion of the Phase Ib part of the present trial, the dose recommended for use in the Phase II part is 170 mg/m2 MBP-426.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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.
Mary Crowley Medical Research Center
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
A.Gvamichava National Center of Cancer
Tbilisi, Georgia
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)
Time frame: 4 months
To characterize the safety profile of the combination therapy
Time frame: 4 months
To determine the plasma and urine pharmacokinetics of MBP-426 when given in combination with leucovorin and 5-FU
Time frame: 4 months
To undertake a preliminary exploration of anti-tumor activity of the combination therapy
Time frame: 4 months
To characterize the safety profile of the combination therapy
Time frame: 16 months
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Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia