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

Phase 1

Completed

• Conditions: Solid Cancers
• Interventions: Drug: MEGF0444A; Drug: bevacizumab; Drug: paclitaxel

• Registration Number: NCT01075464
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	MEGF0444A	-
A	bevacizumab	-
B	MEGF0444A	-
B	bevacizumab	-
B	paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Incidence and nature of dose-limiting toxicities (DLTs)	Days 1 to 28 of Cycle 1
Incidence, nature, and severity of adverse events	Until 90 days after last dose of study treatment

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution	Following administration of study drug