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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

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ClinicalTrials.gov Identifier: NCT01068977
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Solid Cancers Drug: bevacizumab Drug: MetMAb Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  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) [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Objective response, defined as a complete or partial response confirmed ≥4 weeks after initial documentation [ Time Frame: Length of study ]
  2. Duration of objective response [ Time Frame: Length of study ]
  3. Progression-free survival [ Time Frame: Length of study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068977


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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01068977     History of Changes
Other Study ID Numbers: OAM4224g
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Bevacizumab
Antibodies
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors