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 |
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.
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
We found this trial at
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