Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

AbbVie

Status and phase: Completed; Phase 2

Conditions: Advanced or Metastatic Non-Small Cell Lung Cancer

Treatments: Drug: ABT-869; Drug: Carboplatin; Drug: Placebo for ABT-869; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716534

2007-007107-32 (EudraCT Number)

M10-301

Details and patient eligibility

About

This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be at least 18 years of age.
• Subject must have cytologically or histologically confirmed non-squamous NSCLC
• Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
• Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
• Subject has an ECOG Performance Score of 0-1.
• Willing to take adequate measures to prevent pregnancy.

Exclusion criteria

• The subject has NSCLC with a predominant squamous cell histology
• Subject has hypersensitivity to paclitaxel.
• Subject has received any anti-cancer therapy for treatment of NSCLC.
• Subject has received radiation therapy within 21 days of Study Day 1.
• Subject has had major surgery within 21 days.
• Subject has untreated brain or meningeal metastases.
• Subject is receiving therapeutic anticoagulation therapy.
• Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
• Subject has proteinuria CTC Grade > 1 at baseline.
• Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
• The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.
• The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
• The subject has a documented left ventricular (LV) ejection fraction < 50%.
• The subject has known autoimmune disease with renal involvement (i.e., lupus).
• The subject is receiving combination anti-retroviral therapy for HIV.
• The subject has clinically significant uncontrolled condition(s).
• The subject has a history of another active cancer within the past 5 years.
• The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
• The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
• The subject is pregnant or breast feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

12.5 mg ABT-869 + Carboplatin/Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: ABT-869

Drug: ABT-869

B

Experimental group

Description:

7.5 mg ABT-869 + Carboplatin/Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: ABT-869

Drug: ABT-869

C

Placebo Comparator group

Description:

Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Placebo for ABT-869

Drug: Carboplatin