Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

AbbVie

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Treatments: Drug: ABT-869 .25 mg/kg; Drug: ABT-869 0.10 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517790

M06-880

2007-005245-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC
• Subjects must have at least one lesion measurable by CT scan as defined by RECIST
• The measurable lesion may have not received radiation therapy
• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
• Subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic NSCLC. In addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC
• Adequate organ function

Exclusion criteria

• Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy. Prior Avastin is allowed.
• Subject has untreated brain or meningeal metastases.
• History of greater than 10% weight loss
• Subject has clinically relevant hemoptysis
• The subject has proteinuria CTC Grade > 1
• The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 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 < 50%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

ABT-869 0.25 mg/kg

Experimental group

Description:

Approximately half of the subjects were randomized to receive the high dose

Treatment:

Drug: ABT-869 .25 mg/kg

ABT-869 0.10 mg/kg

Experimental group

Description:

Approximately half of the subjects were randomized to receive the Low Dose

Treatment:

Drug: ABT-869 0.10 mg/kg