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

NCT ID: NCT01068977

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage I

Group Type: EXPERIMENTAL

MetMAb

Intervention Type: DRUG

Repeating escalating intravenous dose

Stage II

Group Type: EXPERIMENTAL

MetMAb

Intervention Type: DRUG

Repeating intravenous dose

Stage III

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

Repeating intravenous dose

MetMAb

Intervention Type: DRUG

Repeating escalating intravenous dose

Interventions

bevacizumab

Repeating intravenous dose

Intervention Type: DRUG

MetMAb

Repeating escalating intravenous dose

Intervention Type: DRUG

MetMAb

Repeating intravenous dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Premal Patel, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

OAM4224g

Identifier Type: -

Identifier Source: org_study_id