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

• ClinicalTrials.gov Identifier: NCT01075464
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: November 2, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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.

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01075464
• Other Study ID Numbers: MEF4797g; GO01328 ( Other Identifier: Hoffmann-La Roche )
• First Posted: February 25, 2010
• Last Update Posted: November 2, 2016
• Last Verified: November 2016

Keywords provided by Genentech, Inc.:

Solid Tumor

Additional relevant MeSH terms:

Paclitaxel; Bevacizumab; 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