Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer
NCT ID: NCT00707889
Last Updated: 2013-05-15
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
159 participants
INTERVENTIONAL
2008-10-31
2012-05-31
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
NONE
Study Groups
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A
Open-label to Bevacizumab plus mFOLFOX6
bevacizumab
10 mg/kg QD, IV on Day 1 of each 14-day cycle
oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
fluorouracil
400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
B
Open-label to High-dose ABT-869 arm plus mFOLFOX6
ABT-869
12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle
oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
fluorouracil
400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
C
Open-label to low-dose ABT-869 arm plus mFOLFOX6
oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
fluorouracil
400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
ABT-869
7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle
Interventions
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ABT-869
12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle
bevacizumab
10 mg/kg QD, IV on Day 1 of each 14-day cycle
oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
fluorouracil
400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
ABT-869
7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Subject must have received one prior chemotherapy regimen containing irinotecan or a fluoropyrimidine for locally recurrent or metastatic colon or rectal cancer.
Subject has experienced progressive disease during or following the previous anti-tumor treatment.
Subject may have received prior adjuvant treatment for colorectal cancer. Subject has measurable disease by RECIST criteria (randomized portion only). Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. Subject must have adequate bone marrow, renal and hepatic function. Subject must have Partial Thromboplastin Time (PTT) \< 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) \< 1.5.
Exclusion Criteria
Subject has received cytotoxic chemotherapy within 21 days prior to Study Day 1.
Subject has received non-cytotoxic, anti-cancer therapy within 21 days or within a period defined by 5 half lives whichever is shorter, prior to Study Day 1.
Subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
Subject has received prior treatment with a tyrosine kinase inhibitor targeting VEGF or PDGF.
Subject has received prior treatment with oxaliplatin in the metastatic setting. Lead-in cohort only: Prior treatment with oxaliplatin will be allowed provided that any neuropathy as a result of the oxaliplatin treatment has resolved to less than or equal to Grade 1.
Subject has had major surgery within 28 days of Study Day 1. Subject has had radiotherapy within 14 days of Study Day 1. Subject has a history of hypersensitivity to recombinant murine monoclonal antibodies, oxaliplatin or other platinum-containing compounds, fluorouracil, or folinic acid.
Subject has a known intolerance to bevacizumab. Subject has untreated brain or meningeal metastases. Subject is receiving therapeutic anticoagulation therapy . Subject has a history of/or currently exhibits clinically significant cancer related events of bleeding.
Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
Subject has a history of myocardial infarction, stroke, or transient ischemic attack within six months of Study Day 1.
History of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.
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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Mark D. McKee, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 11341
Chapel Hill, North Carolina, United States
Site Reference ID/Investigator# 20801
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 8360
Nashville, Tennessee, United States
Site Reference ID/Investigator# 18581
Bedford Park, , Australia
Site Reference ID/Investigator# 23443
Herston, , Australia
Site Reference ID/Investigator# 18023
Bonheiden, , Belgium
Site Reference ID/Investigator# 23646
Brussels, , Belgium
Site Reference ID/Investigator# 18026
Leuven, , Belgium
Site Reference ID/Investigator# 18022
Roeselare, , Belgium
Site Reference ID/Investigator# 26662
Jaú, , Brazil
Site Reference ID/Investigator# 24245
Porto Alegre, , Brazil
Site Reference ID/Investigator# 23265
Barrie, , Canada
Site Reference ID/Investigator# 21083
Edmonton, , Canada
Site Reference ID/Investigator# 22465
Ottawa, , Canada
Site Reference ID/Investigator# 22141
Náchod, , Czechia
Site Reference ID/Investigator# 22289
Heraklion, , Greece
Site Reference ID/Investigator# 22286
Thessaloniki, , Greece
Site Reference ID/Investigator# 22287
Thessaloniki, , Greece
Site Reference ID/Investigator# 20281
Wellington South, , New Zealand
Site Reference ID/Investigator# 20141
Olsztyn, , Poland
Site Reference ID/Investigator# 17946
Warsaw, , Poland
Site Reference ID/Investigator# 38284
Warsaw, , Poland
Site Reference ID/Investigator# 23908
Aveiro, , Portugal
Site Reference ID/Investigator# 22324
Coimbra, , Portugal
Site Reference ID/Investigator# 23724
Faro, , Portugal
Site Reference ID/Investigator# 23964
Lisbon, , Portugal
Site Reference ID/Investigator# 23303
Baia Mare, , Romania
Site Reference ID/Investigator# 23302
Brasov, , Romania
Site Reference ID/Investigator# 17962
Bucharest, , Romania
Site Reference ID/Investigator# 17964
Bucharest, , Romania
Site Reference ID/Investigator# 23304
Bucharest, , Romania
Site Reference ID/Investigator# 17961
Cluj-Napoca, , Romania
Site Reference ID/Investigator# 23305
Craiova, , Romania
Site Reference ID/Investigator# 24422
Moscow, , Russia
Site Reference ID/Investigator# 25063
Moscow, , Russia
Site Reference ID/Investigator# 25065
Moscow, , Russia
Site Reference ID/Investigator# 24423
Moscow, , Russia
Site Reference ID/Investigator# 18281
Seoul, , South Korea
Site Reference ID/Investigator# 18283
Seoul, , South Korea
Site Reference ID/Investigator# 18282
Seoul, , South Korea
Site Reference ID/Investigator# 22809
A Coruña, , Spain
Site Reference ID/Investigator# 22807
Barcelona, , Spain
Site Reference ID/Investigator# 22804
Madrid, , Spain
Site Reference ID/Investigator# 22801
Madrid, , Spain
Site Reference ID/Investigator# 22803
Pamplona Navarra, , Spain
Site Reference ID/Investigator# 22800
Santander, , Spain
Countries
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Other Identifiers
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2007-007081-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M10-300
Identifier Type: -
Identifier Source: org_study_id
NCT00788411
Identifier Type: -
Identifier Source: nct_alias
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