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

NCT ID: NCT00909740

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-22

Study Completion Date

2011-10-26

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Cancers

Keywords

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Solid Tumor Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

MEGF0444A

Intervention Type DRUG

Intravenous escalating dose

Interventions

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MEGF0444A

Intravenous escalating dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louie Naumovski, M.D., Ph.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

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United States

Other Identifiers

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MEF4693g

Identifier Type: -

Identifier Source: org_study_id