Advanced Colorectal CancerPhase 2NCT00707889

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

A Phase 2 study testing ABT-869, bevacizumab and oxaliplatin in people with Advanced Colorectal Cancer and Adenocarcinoma of the Colon, run by AbbVie (prior sponsor, Abbott) at 46 sites in 14 countries.

Completed

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

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Colorectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
What is being tested?: ABT-869, bevacizumab and oxaliplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 46 sitesin 14 countries
Study dates: Oct 2008to May 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 >/= 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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

46 sites in 14 countries.

Country

City, postcode or hospital

46 sites in 14 countries

Romania7 sites

Site Reference ID/Investigator# 23303
Baia Mare, 430031
Site Reference ID/Investigator# 23302
Brasov, 500117
Site Reference ID/Investigator# 17962
Bucharest, 022328
Site Reference ID/Investigator# 17964
Bucharest, 022328
Site Reference ID/Investigator# 23304
Bucharest, 050098
Site Reference ID/Investigator# 17961
Cluj-Napoca, 400015
Site Reference ID/Investigator# 23305
Craiova, 200385

Other trials in Romania

Spain6 sites

Site Reference ID/Investigator# 22809
A Coruña, 15006
Site Reference ID/Investigator# 22807
Barcelona, 08907
Site Reference ID/Investigator# 22804
Madrid, 28034
Site Reference ID/Investigator# 22801
Madrid, 28050
Site Reference ID/Investigator# 22803
Pamplona Navarra, 31008
Site Reference ID/Investigator# 22800
Santander, 39008

Other trials in Spain

Belgium4 sites

Site Reference ID/Investigator# 18023
Bonheiden, 2820
Site Reference ID/Investigator# 23646
Brussels, 1200
Site Reference ID/Investigator# 18026
Leuven, 3000
Site Reference ID/Investigator# 18022
Roeselare, 8800

Other trials in Belgium

Portugal4 sites

Site Reference ID/Investigator# 23908
Aveiro, 3814-501
Site Reference ID/Investigator# 22324
Coimbra, 3001-651
Site Reference ID/Investigator# 23724
Faro, 8000-386
Site Reference ID/Investigator# 23964
Lisbon, 1099-023

Other trials in Portugal

Russia4 sites

Site Reference ID/Investigator# 24422
Moscow, 115478
Site Reference ID/Investigator# 25063
Moscow, 115478
Site Reference ID/Investigator# 25065
Moscow, 117997
Site Reference ID/Investigator# 24423
Moscow, 143423

Other trials in Russia

United States3 sites

Site Reference ID/Investigator# 11341
Chapel Hill, North Carolina, 27599-7305
Site Reference ID/Investigator# 8360
Nashville, Tennessee, 37232-6307
Site Reference ID/Investigator# 20801
Philadelphia, Pennsylvania, 19107

Other trials in United States

Canada3 sites

Site Reference ID/Investigator# 23265
Barrie, L4M 6M2
Site Reference ID/Investigator# 21083
Edmonton, T6G 1Z2
Site Reference ID/Investigator# 22465
Ottawa, K1H 8L6

Other trials in Canada

Greece3 sites

Site Reference ID/Investigator# 22289
Heraklion, 71110
Site Reference ID/Investigator# 22286
Thessaloniki, 54007
Site Reference ID/Investigator# 22287
Thessaloniki, 56403

Other trials in Greece

Poland3 sites

Site Reference ID/Investigator# 20141
Olsztyn, 10513
Site Reference ID/Investigator# 17946
Warsaw, 02-781
Site Reference ID/Investigator# 38284
Warsaw, 04-125

Other trials in Poland

South Korea3 sites

Site Reference ID/Investigator# 18281
Seoul, 110-744
Site Reference ID/Investigator# 18283
Seoul, 135-710
Site Reference ID/Investigator# 18282
Seoul, 138-736

Other trials in South Korea

Australia2 sites

Site Reference ID/Investigator# 18581
Bedford Park, 5042
Site Reference ID/Investigator# 23443
Herston, 4029

Other trials in Australia

Brazil2 sites

Site Reference ID/Investigator# 26662
Jaú, 17210-120
Site Reference ID/Investigator# 24245
Porto Alegre, 90610-000

Other trials in Brazil

Czechia1 site

Site Reference ID/Investigator# 22141
Náchod, 54769

Other trials in Czechia

New Zealand1 site

Site Reference ID/Investigator# 20281
Wellington South, 6021

Other trials in New Zealand

About this study

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

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

Conditions: Advanced Colorectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Being tested: ABT-869, bevacizumab, oxaliplatin, folinic acid, fluorouracil
Medical subject headings: Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

ABT-869Drug
12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle
bevacizumabDrug
10 mg/kg QD, IV on Day 1 of each 14-day cycle
oxaliplatinDrug
Also called mFOLFOX6 regimen
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
folinic acidDrug
Also called mFOLFOX6 regimen
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
fluorouracilDrug
Also called mFOLFOX6 regimen
400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
ABT-869Drug
7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle

Study groups in NCT00707889
Study group	Role	What they receive
A	Active comparator	Open-label to Bevacizumab plus mFOLFOX6 Receives: Drug: bevacizumab; Drug: oxaliplatin; Drug: folinic acid; Drug: fluorouracil
B	Active comparator	Open-label to High-dose ABT-869 arm plus mFOLFOX6 Receives: Drug: ABT-869; Drug: oxaliplatin; Drug: folinic acid; Drug: fluorouracil
C	Active comparator	Open-label to low-dose ABT-869 arm plus mFOLFOX6 Receives: Drug: oxaliplatin; Drug: folinic acid; Drug: fluorouracil; Drug: ABT-869

What is being measured

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

Progression-free survival
Measured: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks

Secondary outcomes (3)

Overall survival
Measured: from randomization until patient death or alive at 5 years
12-month overall survival rate
Measured: from randomization until patient death or alive at 5 years
Objective response rate
Measured: from randomization until patient death or alive at 5 years

Timeline

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

Oct 2008May 2012

First posted1 Jul 2008 (estimated)
Study startOct 2008
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Colorectal CancerStudies 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: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00707889
Sponsor's protocol ID: M10-300
Other IDs: 2007-007081-38
Status last verified: May 2013
First submitted: 27 Jun 2008
Last updated: 15 May 2013
Results posted: No
Data monitoring committee: No

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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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00707889
Acronym / sponsor ID: M10-300
Conditions: Advanced Colorectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Genentech, Inc.
Study start: Oct 2008
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 1 Jul 2008 (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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A	Active comparator	Drug: bevacizumab, Drug: oxaliplatin, Drug: folinic acid, Drug: fluorouracilOpen-label to Bevacizumab plus mFOLFOX6
B	Active comparator	Drug: ABT-869, Drug: oxaliplatin, Drug: folinic acid, Drug: fluorouracilOpen-label to High-dose ABT-869 arm plus mFOLFOX6
C	Active comparator	Drug: oxaliplatin, Drug: folinic acid, Drug: fluorouracil, Drug: ABT-869Open-label to low-dose ABT-869 arm plus mFOLFOX6

Who may qualify

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

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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.

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-86912.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle	Drug	B
bevacizumab10 mg/kg QD, IV on Day 1 of each 14-day cycle	Drug	A
oxaliplatinAlso: mFOLFOX6 regimen85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle	Drug	A, B, C
folinic acidAlso: mFOLFOX6 regimen400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle	Drug	A, B, C
fluorouracilAlso: mFOLFOX6 regimen400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours	Drug	A, B, C
ABT-8697.5 mg QD tablets taken orally days 1-14 of every 14-day cycle	Drug	C

Primary outcome

Progression-free survival
Time frame: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks

3 secondary outcomes

Overall survival
Time frame: from randomization until patient death or alive at 5 years
12-month overall survival rate
Time frame: from randomization until patient death or alive at 5 years
Objective response rate
Time frame: from randomization until patient death or alive at 5 years

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 15 May 2013.

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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.

Mark D. McKee, MD study director

AbbVie

46 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Romania, Spain, Belgium, Portugal, Russia and 9 more countries. 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 survival (time frame: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks). 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 NCT00707889.

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 15 May 2013.