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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborator: Genentech, Inc.
• Treatments: Erlotinib Hydrochloride

Criteria

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%.