A Study of the Safety and Pharmacokinetics of MEGF0444A Administered to Patients With Advanced Solid Tumors

Solid Cancers Clinical Trial

Official title:

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909740
• Other study ID #: MEF4693g
• Status: Completed
• Phase: Phase 1
• Start date: May 22, 2009
• Est. completion date: October 26, 2011

Study information

• Verified date: December 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 26, 2011
• Est. primary completion date: October 26, 2011
• Accepts healthy volunteers: No
• Gender: All
• 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

Exclusion Criteria:

• Inadequate hematologic and organ function

• Anti-cancer therapy within 4 weeks prior to initiation of study treatment

• Adverse events from prior anti-cancer therapy that have not resolved to Grade = 1, except for alopecia

• Active infection or autoimmune disease

• Pregnancy (positive pregnancy test) or lactation

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• MEGF0444A
Intravenous escalating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities (DLTs)		Days 1-21 of cycle 1
Primary	Incidence, nature, relatedness, and severity of adverse events		Day 1 to study completion
Secondary	Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution		Following administration of study drug