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

Phase 1

Withdrawn

• Conditions: Solid Tumors
• Interventions: Drug: ABT-869; Drug: Tarceva

• Registration Number: NCT00754104
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-17
• Primary Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2011-01-17
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	ABT-869	-
A	Tarceva	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	Day 7, 15, 21, 35 and Day 1 of every 8 weeks