Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors

NCT ID: NCT00754104

Last Updated: 2011-01-19

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

ABT-869

Intervention Type DRUG

0.25 mg/kg. daily.

Tarceva

Intervention Type DRUG

150mg, daily.

Interventions

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ABT-869

0.25 mg/kg. daily.

Intervention Type DRUG

Tarceva

150mg, daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
* Subject must have an ECOG Score of 0-2.
* Adequate organ function.

Exclusion Criteria

* Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.
* Subject has untreated brain or meningeal metastases.
* History of greater than 10% weight loss.
* Has clinically relevant hemoptysis.
* Subject has proteinuria CTC grade \> 1.
* Must not have had radiation therapy or major surgery within 21 days of study day 1.
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) \> 100 mmHg or systolic blood pressure (SBP) \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
* The subject has a documented left ventricular ejection fraction (LVEF) \< 50%.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Other Identifiers

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M10-371

Identifier Type: -

Identifier Source: org_study_id

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