Study of ABT-869 in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Purpose

The primary objectives of this study are to determine the efficacy of two different doses of ABT-869 using Response Evaluation Criteria in Solid Tumors (RECIST) and to establish the safety/tolerability profile of ABT-869 in subjects with advanced or metastatic NSCLC who have had at least one but no more than two prior lines of systemic treatment.

The secondary objectives of this study are to identify potential biomarkers that correlate and/or predict efficacy and toxicity in subjects with advanced or metastatic NSCLC and to explore if there are any ethnic differences in tumor response to ABT-869 between Asian and non-Asian NSCLC populations.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer (NSCLC)	Drug: ABT-869	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Abbott:

Primary Outcome Measures:

Progression Free Rate (PFR) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective Response Rate (ORR) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2007
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.25 mg/kg: Experimental High dose	Drug: ABT-869 0.25 mg/kg or 0.10 mg/kg
0.10 mg/kg: Experimental Low Dose	Drug: ABT-869 0.25 mg/kg or 0.10 mg/kg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517790

Contacts


Contact: Karen E Burns		Karen.Burns@abbott.com

Contact: Christa A. Lee, BS		christa.lee@abbott.com

Show 38 Study Locations

Sponsors and Collaborators

Abbott

Genentech

Investigators


Study Director:	Joyce Steinberg, MD	Abbott

More Information

Responsible Party:	Abbott ( Rod Humerickhouse, MD, Global Project Head )
Study ID Numbers:	M06-880
First Received:	August 16, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00517790
Health Authority:	United States: Food and Drug Administration; Singapore: Health Sciences Authority

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	Abbott Genentech
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00517790