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

Phase 1

Completed

• Conditions: Solid Cancers
• Interventions: Drug: MetMAb; Drug: bevacizumab

• Registration Number: NCT01068977
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-17
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stage II	MetMAb	-
Stage I	MetMAb	-
Stage III	MetMAb	-
Stage III	bevacizumab	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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