A Phase I, Open Label, Dose Escalation 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
18 Years
N/A
Both
Solid Cancers
Trial Information
A Phase I, Open Label, Dose Escalation 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
Inclusion Criteria:
- Histologic documentation of incurable, locally advanced, or metastatic solid
malignancy that has failed to respond to at least one prior regimen or for which
there is no standard therapy
- Disease that is measurable or evaluable by Response Evaluation Criteria In Solid
Tumors (RECIST)
- Life expectancy ≥12 weeks
Exclusion Criteria:
- Less than 4 weeks since the last anti‑tumor therapy
- Patients receiving erythropoietin products
- Active infection requiring antibiotics
- Active autoimmune disease that is not controlled by nonsteroidal anti‑inflammatory
drugs
- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Clinically important history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis
- Known human immunodeficiency virus infection
- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Outcome Time Frame:
Length of study
Safety Issue:
No
Principal Investigator
Premal Patel, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
OAM4224g
NCT ID:
NCT01068977
Start Date:
August 2007
Completion Date:
Related Keywords:
- Solid Cancers
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