A Study of the Safety and Pharmacokinetics of MEGF0444A Administered to Patients With Advanced Solid Tumors
- Registration Number
- NCT00909740
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit
Exclusion Criteria
- Inadequate hematologic and organ function
- Anti-cancer therapy within 4 weeks prior to initiation of study treatment
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
- Active infection or autoimmune disease
- Pregnancy (positive pregnancy test) or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MEGF0444A -
- Primary Outcome Measures
Name Time Method Incidence and nature of dose-limiting toxicities (DLTs) Days 1-21 of cycle 1 Incidence, nature, relatedness, and severity of adverse events Day 1 to study completion
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution Following administration of study drug