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

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AbbVie

Status and phase

Completed
Phase 2

Conditions

Advanced or Metastatic Non-Small Cell Lung Cancer

Treatments

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

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

145 participants in 3 patient groups, including a placebo group

A
Experimental group
Description:
12.5 mg ABT-869 + Carboplatin/Paclitaxel
Treatment:
Drug: Carboplatin
Drug: ABT-869
Drug: Paclitaxel
B
Experimental group
Description:
7.5 mg ABT-869 + Carboplatin/Paclitaxel
Treatment:
Drug: Carboplatin
Drug: ABT-869
Drug: Paclitaxel
C
Placebo Comparator group
Description:
Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
Treatment:
Drug: Placebo for ABT-869
Drug: Carboplatin
Drug: Paclitaxel

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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