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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01075464
First received: February 24, 2010
Last updated: August 4, 2014
Last verified: August 2014

February 24, 2010
August 4, 2014
February 2010
April 2013   (final data collection date for primary outcome measure)
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1 to 28 of Cycle 1 ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Until 90 days after last dose of study treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01075464 on ClinicalTrials.gov Archive Site
Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution [ Time Frame: Following administration of study drug ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combinatio n with bevacizumab, and in combination with bevacizumab and paclitaxel as therap y for locally advanced or metastatic solid tumors.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: MEGF0444A
    Intravenous escalating dose
  • Drug: paclitaxel
    Intravenous repeating dose
  • Experimental: A
    Interventions:
    • Drug: bevacizumab
    • Drug: MEGF0444A
  • Experimental: B
    Interventions:
    • Drug: bevacizumab
    • Drug: MEGF0444A
    • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01075464
MEF4797g, GO01328
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP