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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT01068977
First received: February 12, 2010
Last updated: November 11, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Solid Cancers
Drug: bevacizumab
Drug: MetMAb
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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) [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response, defined as a complete or partial response confirmed ≥4 weeks after initial documentation [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: August 2007
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage I Drug: MetMAb
Repeating escalating intravenous dose
Experimental: Stage II Drug: MetMAb
Repeating intravenous dose
Experimental: Stage III Drug: bevacizumab
Repeating intravenous dose
Drug: MetMAb
Repeating escalating intravenous dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068977

Sponsors and Collaborators
Genentech
Investigators
Study Director: Premal Patel, M.D. Genentech
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01068977     History of Changes
Other Study ID Numbers: OAM4224g
Study First Received: February 12, 2010
Last Updated: November 11, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014