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A Study of the Safety and Pharmacology of MEGF0444A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01075464
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Solid Cancers Drug: MEGF0444A Drug: bevacizumab Drug: paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MEGF0444A, a Human IgG1 Antibody, in Combination With Bevacizumab and Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
Study Start Date : February 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: MEGF0444A
Intravenous escalating dose

Drug: bevacizumab
Intravenous repeating dose

Experimental: B Drug: MEGF0444A
Intravenous escalating dose

Drug: bevacizumab
Intravenous repeating dose

Drug: paclitaxel
Intravenous repeating dose

Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1 to 28 of Cycle 1 ]
  2. Incidence, nature, and severity of adverse events [ Time Frame: Until 90 days after last dose of study treatment ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution [ Time Frame: Following administration of study drug ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit

Specific to Arm A:

  • For patients undergoing optional or mandatory exploratory MRI, at least one tumor lesion that represents a liver, fixed peritoneal, neck, extremity, or pelvic lesion measuring >/= 3 to 10 cm (for liver lesions) or >= 2 to 10 cm (for all other lesion locations) to be used for MRI

Specific to Arm B:

  • Maximum of two prior chemotherapy regimens for metastatic disease

Exclusion Criteria:

  • Anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Patients who had to discontinue prior bevacizumab therapy due to intolerable toxicity
  • Leptomeningeal disease
  • Active infection or autoimmune disease
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
  • Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
  • Inadequately controlled hypertension; history of hypertensive crisis or encephalopathy; congestive heart failure (New York Heart Association Class II or greater); history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
  • History of hemoptysis; evidence of bleeding diathesis or significant coagulopathy
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment
  • Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture

Specific to Arm B:

  • Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
  • Previous intolerance to paclitaxel
  • Grade >= 2 sensory neuropathy

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 identifier (NCT number): NCT01075464

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United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
San Francisco, California, United States, 94115
Santa Monica, California, United States, 90404
United States, Florida
Tampa, Florida, United States, 33612
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc. Identifier: NCT01075464    
Other Study ID Numbers: MEF4797g
GO01328 ( Other Identifier: Hoffmann-La Roche )
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Keywords provided by Genentech, Inc.:
Solid Tumor
Additional relevant MeSH terms:
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Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors