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

Genentech

Status and phase

Completed

Phase 1

Conditions

Solid Cancers

Treatments

Drug: paclitaxel

Drug: bevacizumab

Drug: MEGF0444A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01075464

GO01328 (Other Identifier)

MEF4797g

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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