CClinicalTrials.gg
CompletedNCT01075464Updated Nov 2, 2016

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 1 interventional study of MEGF0444A and bevacizumab in Solid Cancers, sponsored by Genentech, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Cancers

Keywords

  • Solid Tumor
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    A

    Drug: MEGF0444A · Drug: bevacizumab

  • Experimental
    B

    Drug: MEGF0444A · Drug: bevacizumab · Drug: paclitaxel

Interventions

  • DrugMEGF0444A

    Intravenous escalating dose

  • Drugbevacizumab

    Intravenous repeating dose

  • Drugpaclitaxel

    Intravenous repeating dose

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution

    Time frame: Following administration of study drug

07

Study locations

5 sites
  • Scottsdale, Arizona 85258, United States
  • San Francisco, California 94115, United States
  • Santa Monica, California 90404, United States
  • Tampa, Florida 33612, United States
  • Nashville, Tennessee 37203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01075464
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Feb 25, 2010
Start date
Feb 2010
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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