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OpenTrials
Completed

NCT Number: NCT01068977

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 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.

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Key information

Conditions

Solid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Repeating intravenous dose

MetMAb

Drug

Repeating escalating intravenous dose

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)

    Time frame: Length of study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 17, 2010
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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