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
Completed · Phase 1
Conditions studied: Solid Cancers
In brief
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.
Key facts
- Study ID
- NCT01075464
- Run by
- Genentech, Inc.
- People needed
- 64
- Starts
- 2010-02-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Scottsdale, Arizona, United States
- Study site — San Francisco, California, United States
- Study site — Santa Monica, California, United States
- Study site — Tampa, Florida, United States
- Study site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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