Gastric Adenocarcinoma Clinical Trial
Official title:
A Phase Ib/II Study of MBP-426 in Patients With Second Line Gastric, Gastro Esophageal, or Esophageal Adenocarcinoma
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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