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



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:February 2010
End Date:April 2013

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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 combination with
bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally
advanced or metastatic solid tumors.


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
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