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

NCT01068977 | Completed Phase 1

• 1 other identifier: OAM4224g
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Solid Cancers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective response, defined as a complete or partial response confirmed ≥4 weeks after initial documentation

  Length of study

• Duration of objective response

  Length of study

• Progression-free survival

  Length of study

Study Arms (3)

Stage I

EXPERIMENTAL

Drug: MetMAb

Stage II

EXPERIMENTAL

Drug: MetMAb

Stage III

EXPERIMENTAL

Drug: bevacizumab; Drug: MetMAb

Interventions

bevacizumab DRUG

Repeating intravenous dose

Stage III

MetMAb DRUG

Repeating escalating intravenous dose

Stage I; Stage III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Interventions

Bevacizumab; onartuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Premal Patel, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 17, 2010
• Study Start: August 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 19, 2017

Record last verified: 2017-05