Spots Global Cancer Trial Database for Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma

Study Description

Brief 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial