Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT00517790

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

A Phase 2 study testing ABT-869 .25 mg/kg and ABT-869 0.10 mg/kg in people with Non-Small Cell Lung Cancer (NSCLC), run by AbbVie (prior sponsor, Abbott) at 28 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer (NSCLC)
What is being tested?: ABT-869 .25 mg/kg and ABT-869 0.10 mg/kg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 28 sitesin 5 countries
Study dates: Aug 2007to Jun 2012
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

28 sites in 5 countries.

Country

City, postcode or hospital

28 sites in 5 countries

United States18 sites

Site Reference ID/Investigator# 5646
Aurora, Colorado, 80045-0510
Site Reference ID/Investigator# 5652
Buffalo, New York, 14263
Site Reference ID/Investigator# 6184
Charlotte, North Carolina, 28211
Site Reference ID/Investigator# 5648
Chicago, Illinois, 60637
Site Reference ID/Investigator# 6680
East Orange, New Jersey, 07018
Site Reference ID/Investigator# 6739
Evanston, Illinois, 60201
Site Reference ID/Investigator# 7194
Fountain Valley, California, 92708
Site Reference ID/Investigator# 6777
Greensboro, North Carolina, 27403
Site Reference ID/Investigator# 8100
Harvey, Illinois, 60426
Site Reference ID/Investigator# 5269
Indianapolis, Indiana, 46202
Site Reference ID/Investigator# 5617
Los Angeles, California, 90033
Site Reference ID/Investigator# 5650
Memphis, Tennessee, 38120
Site Reference ID/Investigator# 7868
Newark, Delaware, 19718
Site Reference ID/Investigator# 7616
Port Saint Lucie, Florida, 34952
Site Reference ID/Investigator# 7934
Sacramento, California, 95817
Site Reference ID/Investigator# 6042
St Louis, Missouri, 63110
Site Reference ID/Investigator# 5603
Voorhees Township, New Jersey, 08043
Site Reference ID/Investigator# 6627
Waterbury, Connecticut, 06708

Other trials in United States

Canada3 sites

Site Reference ID/Investigator# 6040
Barrie, L4M 6M2
Site Reference ID/Investigator# 5275
Ottawa, K1H 8L6
Site Reference ID/Investigator# 6572
Toronto, M5G 2M9

Other trials in Canada

France3 sites

Site Reference ID/Investigator# 7756
Marseille, 13274
Site Reference ID/Investigator# 8068
Toulouse, 31059
Site Reference ID/Investigator# 8069
Villejuif, 94805

Other trials in France

Singapore2 sites

Site Reference ID/Investigator# 5660
Singapore, 119228
Site Reference ID/Investigator# 5534
Singapore, 169610

Other trials in Singapore

Taiwan2 sites

Site Reference ID/Investigator# 5663
Taichung, 40705
Site Reference ID/Investigator# 5640
Taipei, 10002

Other trials in Taiwan

About this 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)

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

Conditions: Non-Small Cell Lung Cancer (NSCLC)
Being tested: ABT-869 .25 mg/kg, ABT-869 0.10 mg/kg
Keywords: Refractory, Metastatic
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-869 .25 mg/kgDrug
Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
ABT-869 0.10 mg/kgDrug
Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.

Study groups in NCT00517790
Study group	Role	What they receive
ABT-869 0.25 mg/kg	Experimental	Approximately half of the subjects were randomized to receive the high dose Receives: Drug: ABT-869 .25 mg/kg
ABT-869 0.10 mg/kg	Experimental	Approximately half of the subjects were randomized to receive the Low Dose Receives: Drug: ABT-869 0.10 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Rate (PFR)
Measured: Week 16

Secondary outcomes (1)

Objective Response Rate
Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Jun 2012

First posted17 Aug 2007 (estimated)
Study startAug 2007
Primary completionJun 2011
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00517790
Sponsor's protocol ID: M06-880
Other IDs: 2007-005245-37
Status last verified: Jan 2013
First submitted: 16 Aug 2007
Last updated: 5 Apr 2013
Results posted: No
Data monitoring committee: No

Publications

Tan EH, Goss GD, Salgia R, Besse B, Gandara DR, Hanna NH, Yang JC, Thertulien R, Wertheim M, Mazieres J, Hensing T, Lee C, Gupta N, Pradhan R, Qian J, Qin Q, Scappaticci FA, Ricker JL, Carlson DM, Soo RA. Phase 2 trial of Linifanib (ABT-869) in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2011 Aug;6(8):1418-25. doi: 10.1097/JTO.0b013e318220c93e.
PubMed 21597387

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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All Non-Small Cell Lung Cancer (NSCLC) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00517790
Acronym / sponsor ID: M06-880
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Keywords: Refractory, Metastatic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Genentech, Inc.
Study start: Aug 2007
Primary completion: Jun 2011 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Aug 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ABT-869 0.25 mg/kg	Experimental	Drug: ABT-869 .25 mg/kgApproximately half of the subjects were randomized to receive the high dose
ABT-869 0.10 mg/kg	Experimental	Drug: ABT-869 0.10 mg/kgApproximately half of the subjects were randomized to receive the Low Dose

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-869 .25 mg/kgSubjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.	Drug	ABT-869 0.25 mg/kg
ABT-869 0.10 mg/kgSubjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.	Drug	ABT-869 0.10 mg/kg

Primary outcome

Progression Free Rate (PFR)
Time frame: Week 16

1 secondary outcome

Objective Response Rate
Time frame: Week 16

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
Derived from this study: PubMed 21597387Tan EH, Goss GD, Salgia R, Besse B, Gandara DR, Hanna NH, Yang JC, Thertulien R, Wertheim M, Mazieres J, Hensing T, Lee C, Gupta N, Pradhan R, Qian J, Qin Q, Scappaticci FA, Ricker JL, Carlson DM, Soo RA. Phase 2 trial of Linifanib (ABT-869) in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2011 Aug;6(8):1418-25. doi: 10.1097/JTO.0b013e318220c93e.

Related trials for Non-Small Cell Lung Cancer (NSCLC)

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Justin Ricker, MD study director

AbbVie

28 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-869 .25 mg/kg and ABT-869 0.10 mg/kg in people with Non-Small Cell Lung Cancer (NSCLC), run by AbbVie (prior sponsor, Abbott) at 28 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Canada, France, Singapore, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Rate (PFR) (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00517790, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.