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

Abbott

Status and phase: Withdrawn; Phase 1

Conditions: Solid Tumors

Treatments: Drug: ABT-869; Drug: Tarceva

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754104

M10-371

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

A

Experimental group

Treatment:

Drug: ABT-869

Drug: Tarceva