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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

NCT ID: NCT01075464

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Cancers

Keywords

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

MEGF0444A

Intervention Type DRUG

Intravenous escalating dose

bevacizumab

Intervention Type DRUG

Intravenous repeating dose

B

Group Type EXPERIMENTAL

MEGF0444A

Intervention Type DRUG

Intravenous escalating dose

bevacizumab

Intervention Type DRUG

Intravenous repeating dose

paclitaxel

Intervention Type DRUG

Intravenous repeating dose

Interventions

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MEGF0444A

Intravenous escalating dose

Intervention Type DRUG

bevacizumab

Intravenous repeating dose

Intervention Type DRUG

paclitaxel

Intravenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Scottsdale, Arizona, United States

Site Status

San Francisco, California, United States

Site Status

Santa Monica, California, United States

Site Status

Tampa, Florida, United States

Site Status

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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GO01328

Identifier Type: OTHER

Identifier Source: secondary_id

MEF4797g

Identifier Type: -

Identifier Source: org_study_id