Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
MacroGenics
OBJECTIVES: * Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent adenocarcinoma. * Determine the toxicity profile of this drug in these patients. * Determine the pharmacokinetics and immunogenicity of this drug in these patients. * Determine, preliminarily, the antitumor activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive RAV12 IV over 2 hours 2-3 times per week in weeks 1-4 (course 1). Patients are evaluated for response on day 43. Patients achieving a partial or complete response may be eligible to receive additional courses of RAV12 as above. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of RAV12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 15 additional patients are treated at the MTD in 1 or more patients groups (e.g., colorectal, pancreatic, gastroesophageal, and other adenocarcinoma). After completion of study treatment, patients are followed within 4 weeks and then every 6-12 months thereafter. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
