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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00707889




Registration number
NCT00707889
Ethics application status
Date submitted
27/06/2008
Date registered
1/07/2008
Date last updated
15/05/2013

Titles & IDs
Public title
Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer
Scientific 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
Secondary ID [1] 0 0
2007-007081-38
Secondary ID [2] 0 0
M10-300
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Colorectal Cancer 0 0
Adenocarcinoma of the Colon 0 0
Adenocarcinoma of the Rectum 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-869
Treatment: Drugs - bevacizumab
Treatment: Drugs - oxaliplatin
Treatment: Drugs - folinic acid
Treatment: Drugs - fluorouracil
Treatment: Drugs - ABT-869

Active comparator: A - Open-label to Bevacizumab plus mFOLFOX6

Active comparator: B - Open-label to High-dose ABT-869 arm plus mFOLFOX6

Active comparator: C - Open-label to low-dose ABT-869 arm plus mFOLFOX6


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

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

Treatment: Drugs: oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle

Treatment: Drugs: folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle

Treatment: Drugs: fluorouracil
400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours

Treatment: Drugs: ABT-869
7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Radiographic evaluation every 2 months, clinial evaluation every 2 weeks
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
from randomization until patient death or alive at 5 years
Secondary outcome [2] 0 0
12-month overall survival rate
Timepoint [2] 0 0
from randomization until patient death or alive at 5 years
Secondary outcome [3] 0 0
Objective response rate
Timepoint [3] 0 0
from randomization until patient death or alive at 5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 18581 - Bedford Park
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 23443 - Herston
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
Belgium
State/province [4] 0 0
Bonheiden
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Roeselare
Country [8] 0 0
Brazil
State/province [8] 0 0
Jau
Country [9] 0 0
Brazil
State/province [9] 0 0
Porto Alegre
Country [10] 0 0
Canada
State/province [10] 0 0
Barrie
Country [11] 0 0
Canada
State/province [11] 0 0
Edmonton
Country [12] 0 0
Canada
State/province [12] 0 0
Ottawa
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Nachod
Country [14] 0 0
Greece
State/province [14] 0 0
Heraklion
Country [15] 0 0
Greece
State/province [15] 0 0
Thessaloniki
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
New Zealand
State/province [17] 0 0
Wellington South
Country [18] 0 0
Poland
State/province [18] 0 0
Olsztyn
Country [19] 0 0
Poland
State/province [19] 0 0
Warsaw
Country [20] 0 0
Portugal
State/province [20] 0 0
Aveiro
Country [21] 0 0
Portugal
State/province [21] 0 0
Coimbra
Country [22] 0 0
Portugal
State/province [22] 0 0
Faro
Country [23] 0 0
Portugal
State/province [23] 0 0
Lisbon
Country [24] 0 0
Romania
State/province [24] 0 0
Baia Mare
Country [25] 0 0
Romania
State/province [25] 0 0
Brasov
Country [26] 0 0
Romania
State/province [26] 0 0
Bucharest
Country [27] 0 0
Romania
State/province [27] 0 0
Cluj Napoca
Country [28] 0 0
Romania
State/province [28] 0 0
Craiova
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Spain
State/province [30] 0 0
A Coruna
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Spain
State/province [33] 0 0
Pamplona Navarra
Country [34] 0 0
Spain
State/province [34] 0 0
Santander

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.
Trial website
https://clinicaltrials.gov/study/NCT00707889
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark D. McKee, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00707889