This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions. Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21 evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients. Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Ghent, Belgium
Pfizer Investigational Site
Leuven, Belgium
Pfizer Investigational Site
Lille, France
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Kaohsiung City, Taiwan
Pfizer Investigational Site
Kwei-Shan, Taiwan
Pfizer Investigational Site
Birmingham, United Kingdom
Pfizer Investigational Site
To assess the antitumor activity of edotecarin by repeating radiographic assessments at 6-week intervals for all patients.
To determine the time of onset and duration of tumor control, and overall survival.
In addition, the safety and tolerability profile of edotecarin will be assessed, and plasma pharmacokinetic (PK) profile of edotecarin will be evaluated.
Blood samples for PK evaluation will be collected during Cycles 1 and 2 and limited to the patients included in the first stage of the study.
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