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

Solid Cancers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075464
• Other study ID #: MEF4797g
• Secondary ID: GO01328
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2010
• Last updated: November 1, 2016
• Start date: February 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• MEGF0444A
Intravenous escalating dose
• bevacizumab
Intravenous repeating dose
• paclitaxel
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities (DLTs)		Days 1 to 28 of Cycle 1	No
Primary	Incidence, nature, and severity of adverse events		Until 90 days after last dose of study treatment	No
Secondary	Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution		Following administration of study drug	No