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Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT00707889
Collaborator
Genentech, Inc. (Industry)
159
Enrollment
46
Locations
3
Arms
43
Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Open-label to Bevacizumab plus mFOLFOX6

Drug: bevacizumab
10 mg/kg QD, IV on Day 1 of each 14-day cycle

Drug: oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
Other Names:
  • mFOLFOX6 regimen

    • Drug: folinic acid
    400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
    Other Names:
  • mFOLFOX6 regimen

    • Drug: fluorouracil
    400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
    Other Names:
  • mFOLFOX6 regimen

    		•
    Active Comparator: B

    Open-label to High-dose ABT-869 arm plus mFOLFOX6

    Drug: ABT-869
    12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle

    Drug: oxaliplatin
    85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
    Other Names:
  • mFOLFOX6 regimen

    • Drug: folinic acid
    400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
    Other Names:
  • mFOLFOX6 regimen

    • Drug: fluorouracil
    400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
    Other Names:
  • mFOLFOX6 regimen

    		•
    Active Comparator: C

    Open-label to low-dose ABT-869 arm plus mFOLFOX6

    Drug: oxaliplatin
    85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
    Other Names:
  • mFOLFOX6 regimen

    • Drug: folinic acid
    400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
    Other Names:
  • mFOLFOX6 regimen

    • Drug: fluorouracil
    400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
    Other Names:
  • mFOLFOX6 regimen

    • Drug: ABT-869
    7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [Radiographic evaluation every 2 months, clinial evaluation every 2 weeks]

    Secondary Outcome Measures

    1. Overall survival [from randomization until patient death or alive at 5 years]

    2. 12-month overall survival rate [from randomization until patient death or alive at 5 years]

    3. Objective response rate [from randomization until patient death or alive at 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Subject must be >/= 18 years of age. Subject (male or female) must be diagnosed with adenocarcinoma of the colon or rectum. Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.

    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 more than one prior therapy in the metastatic setting. Lead-in Cohort only: The subject may have received more than one prior therapy in the metastatic setting.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 11341 Chapel Hill North Carolina United States 27599-7305
    2 Site Reference ID/Investigator# 20801 Philadelphia Pennsylvania United States 19107
    3 Site Reference ID/Investigator# 8360 Nashville Tennessee United States 37232-6307
    4 Site Reference ID/Investigator# 18581 Bedford Park Australia 5042
    5 Site Reference ID/Investigator# 23443 Herston Australia 4029
    6 Site Reference ID/Investigator# 18023 Bonheiden Belgium 2820
    7 Site Reference ID/Investigator# 23646 Brussels Belgium 1200
    8 Site Reference ID/Investigator# 18026 Leuven Belgium 3000
    9 Site Reference ID/Investigator# 18022 Roeselare Belgium 8800
    10 Site Reference ID/Investigator# 26662 Jau Brazil 17210-120
    11 Site Reference ID/Investigator# 24245 Porto Alegre Brazil 90610-000
    12 Site Reference ID/Investigator# 23265 Barrie Canada L4M 6M2
    13 Site Reference ID/Investigator# 21083 Edmonton Canada T6G 1Z2
    14 Site Reference ID/Investigator# 22465 Ottawa Canada K1H 8L6
    15 Site Reference ID/Investigator# 22141 Nachod Czech Republic 54769
    16 Site Reference ID/Investigator# 22289 Heraklion Greece 71110
    17 Site Reference ID/Investigator# 22286 Thessaloniki Greece 54007
    18 Site Reference ID/Investigator# 22287 Thessaloniki Greece 56403
    19 Site Reference ID/Investigator# 18281 Seoul Korea, Republic of 110-744
    20 Site Reference ID/Investigator# 18283 Seoul Korea, Republic of 135-710
    21 Site Reference ID/Investigator# 18282 Seoul Korea, Republic of 138-736
    22 Site Reference ID/Investigator# 20281 Wellington South New Zealand 6021
    23 Site Reference ID/Investigator# 20141 Olsztyn Poland 10513
    24 Site Reference ID/Investigator# 17946 Warsaw Poland 02-781
    25 Site Reference ID/Investigator# 38284 Warsaw Poland 04-125
    26 Site Reference ID/Investigator# 23908 Aveiro Portugal 3814-501
    27 Site Reference ID/Investigator# 22324 Coimbra Portugal 3001-651
    28 Site Reference ID/Investigator# 23724 Faro Portugal 8000-386
    29 Site Reference ID/Investigator# 23964 Lisbon Portugal 1099-023
    30 Site Reference ID/Investigator# 23303 Baia Mare Romania 430031
    31 Site Reference ID/Investigator# 23302 Brasov Romania 500117
    32 Site Reference ID/Investigator# 17962 Bucharest Romania 022328
    33 Site Reference ID/Investigator# 17964 Bucharest Romania 022328
    34 Site Reference ID/Investigator# 23304 Bucharest Romania 050098
    35 Site Reference ID/Investigator# 17961 Cluj Napoca Romania 400015
    36 Site Reference ID/Investigator# 23305 Craiova Romania 200385
    37 Site Reference ID/Investigator# 24422 Moscow Russian Federation 115478
    38 Site Reference ID/Investigator# 25063 Moscow Russian Federation 115478
    39 Site Reference ID/Investigator# 25065 Moscow Russian Federation 117997
    40 Site Reference ID/Investigator# 24423 Moscow Russian Federation 143423
    41 Site Reference ID/Investigator# 22809 A Coruna Spain 15006
    42 Site Reference ID/Investigator# 22807 Barcelona Spain 08907
    43 Site Reference ID/Investigator# 22804 Madrid Spain 28034
    44 Site Reference ID/Investigator# 22801 Madrid Spain 28050
    45 Site Reference ID/Investigator# 22803 Pamplona Navarra Spain 31008
    46 Site Reference ID/Investigator# 22800 Santander Spain 39008

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)
    • Genentech, Inc.

    Investigators

    • Study Director: Mark D. McKee, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT00707889
    Other Study ID Numbers:
    • M10-300
    • 2007-007081-38
    • NCT00788411
    First Posted:
    Jul 1, 2008
    Last Update Posted:
    May 15, 2013
    Last Verified:
    May 1, 2013
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Adenocarcinoma
    Leucovorin
    Folic Acid
    Bevacizumab
    Fluorouracil
    Oxaliplatin
    Levoleucovorin

    Study Results

    No Results Posted as of May 15, 2013