Skip to main content
OpenTrials
Completed

NCT Number: NCT00909740

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Cancers Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEGF0444A

Drug

Intravenous escalating dose

Primary outcomes

  1. Incidence and nature of dose-limiting toxicities (DLTs)

    Time frame: Days 1-21 of cycle 1

  2. Incidence, nature, relatedness, and severity of adverse events

    Time frame: Day 1 to study completion

Secondary outcomes

  1. Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution

    Time frame: Following administration of study drug

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 28, 2009
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.