NCT00909740

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2009

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

May 22, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2011

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

May 20, 2009

Last Update Submit

December 9, 2022

Conditions

Solid Cancers

Keywords

Solid TumorCancer

Outcome Measures

Primary Outcomes (2)

  • Incidence and nature of dose-limiting toxicities (DLTs)

    Days 1-21 of cycle 1

  • Incidence, nature, relatedness, and severity of adverse events

    Day 1 to study completion

Secondary Outcomes (1)

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

    Following administration of study drug

Study Arms (1)

1

EXPERIMENTAL
Drug: MEGF0444A

Interventions

MEGF0444ADRUG

Intravenous escalating dose

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

parsatuzumab

Study Officials

  • Louie Naumovski, M.D., Ph.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 28, 2009

Study Start

May 22, 2009

Primary Completion

October 26, 2011

Study Completion

October 26, 2011

Last Updated

December 12, 2022

Record last verified: 2022-12