A Study of the Safety and Pharmacology of MetMAb (PRO143966), a Monovalent Antagonist Antibody to the Receptor C-Met, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

Sponsor
Genentech, Inc.
Study ID
NCT01068977
Phase
PHASE1
Status
Completed

Conditions

  • Solid Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    Repeating intravenous dose
  • MetMAb — DRUG
    Repeating escalating intravenous dose
  • MetMAb — DRUG
    Repeating intravenous dose

Study Details

This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.

Key Dates

First listed
Feb 17, 2010
Start date
Aug 31, 2007
Status verified
May 2017
Primary completion
Jan 31, 2010
Completion
Jan 31, 2010

Study Design

Enrollment
44 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stage I
  • Experimental: Stage II
  • Experimental: Stage III

Primary Outcome Measure

Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters) [ Time Frame: Length of study ]

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