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

Solid Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068977
• Other study ID #: OAM4224g
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2010
• Last updated: May 18, 2017
• Start date: August 2007
• Est. completion date: January 2010

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• bevacizumab
Repeating intravenous dose
• MetMAb
Repeating escalating intravenous dose
• MetMAb
Repeating intravenous dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Length of study
Secondary	Objective response, defined as a complete or partial response confirmed =4 weeks after initial documentation		Length of study
Secondary	Duration of objective response		Length of study
Secondary	Progression-free survival		Length of study