Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00716534
Last Updated: 2013-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
145 participants
INTERVENTIONAL
2008-06-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
12.5 mg ABT-869 + Carboplatin/Paclitaxel
ABT-869
12.5 mg ABT-869
Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Paclitaxel
Paclitaxel (200 mg/m2)
B
7.5 mg ABT-869 + Carboplatin/Paclitaxel
ABT-869
7.5 mg ABT-869
Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Paclitaxel
Paclitaxel (200 mg/m2)
C
Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
Placebo for ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)
Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Paclitaxel
Paclitaxel (200 mg/m2)
Interventions
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ABT-869
12.5 mg ABT-869
Placebo for ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)
ABT-869
7.5 mg ABT-869
Carboplatin
Carboplatin (AUC 6 mg/mL/min)
Paclitaxel
Paclitaxel (200 mg/m2)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Justin L. Ricker, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 15850
Chandler, Arizona, United States
Site Reference ID/Investigator# 15846
Peoria, Arizona, United States
Site Reference ID/Investigator# 15841
Miami, Florida, United States
Site Reference ID/Investigator# 7179
Atlanta, Georgia, United States
Site Reference ID/Investigator# 15851
Lansing, Michigan, United States
Site Reference ID/Investigator# 15844
Lebanon, New Hampshire, United States
Site Reference ID/Investigator# 22443
Hackensack, New Jersey, United States
Site Reference ID/Investigator# 15848
Greensboro, North Carolina, United States
Site Reference ID/Investigator# 22444
Canton, Ohio, United States
Site Reference ID/Investigator# 15847
Cleveland, Ohio, United States
Site Reference ID/Investigator# 26842
Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 13101
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 24122
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 19042
Bedford Park, , Australia
Site Reference ID/Investigator# 23682
Cairns, , Australia
Site Reference ID/Investigator# 21862
Lismore, , Australia
Site Reference ID/Investigator# 19043
Woodville South, , Australia
Site Reference ID/Investigator# 17703
Jaú, , Brazil
Site Reference ID/Investigator# 23522
Porto Alegre, , Brazil
Site Reference ID/Investigator# 15601
Porto Alegre, , Brazil
Site Reference ID/Investigator# 17704
Rio de Janeiro, , Brazil
Site Reference ID/Investigator# 22684
Santo André, , Brazil
Site Reference ID/Investigator# 17702
São Paulo, , Brazil
Site Reference ID/Investigator# 23582
São Paulo, , Brazil
Site Reference ID/Investigator# 18964
Kyjov, , Czechia
Site Reference ID/Investigator# 22504
Náchod, , Czechia
Site Reference ID/Investigator# 18963
Olomouc, , Czechia
Site Reference ID/Investigator# 18962
Prague, , Czechia
Site Reference ID/Investigator# 19022
Pribram V, , Czechia
Site Reference ID/Investigator# 38003
Kazan', , Russia
Site Reference ID/Investigator# 38260
Kirov, , Russia
Site Reference ID/Investigator# 18064
Moscow, , Russia
Site Reference ID/Investigator# 18065
Moscow, , Russia
Site Reference ID/Investigator# 23312
Moscow, , Russia
Site Reference ID/Investigator# 18066
Moscow, , Russia
Site Reference ID/Investigator# 23562
Saint Petersburg, , Russia
Site Reference ID/Investigator# 18961
Singapore, , Singapore
Countries
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References
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Ramalingam SS, Shtivelband M, Soo RA, Barrios CH, Makhson A, Segalla JG, Pittman KB, Kolman P, Pereira JR, Srkalovic G, Belani CP, Axelrod R, Owonikoko TK, Qin Q, Qian J, McKeegan EM, Devanarayan V, McKee MD, Ricker JL, Carlson DM, Gorbunova VA. Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5.
Other Identifiers
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2007-007107-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M10-301
Identifier Type: -
Identifier Source: org_study_id
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