Clinical trial NCT01075464: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Cancers
Keywords: Solid Tumor
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence and nature of dose-limiting toxicities (DLTs)
timeFrame: Days 1 to 28 of Cycle 1
measure: Incidence, nature, and severity of adverse events
timeFrame: Until 90 days after last dose of study treatment
Secondary outcomes:
measure: Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution
timeFrame: Following administration of study drug
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: