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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01075464

Enrollment

Registered

2010-02-25

Start date

2010-02-28

Completion date

2013-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Cancers

Keywords

Solid Tumor

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.

Interventions

DRUGMEGF0444A

Intravenous escalating dose

DRUGbevacizumab

Intravenous repeating dose

DRUGpaclitaxel

Intravenous repeating dose

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence and nature of dose-limiting toxicities (DLTs)	Days 1 to 28 of Cycle 1
Incidence, nature, and severity of adverse events	Until 90 days after last dose of study treatment

Secondary

Measure	Time frame
Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution	Following administration of study drug

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026