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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00707889
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : May 15, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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
Advanced Colorectal Cancer Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Drug: ABT-869 Drug: bevacizumab Drug: oxaliplatin Drug: folinic acid Drug: fluorouracil Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : October 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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 Name: mFOLFOX6 regimen

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

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

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

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




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: from randomization until patient death or alive at 5 years ]
  2. 12-month overall survival rate [ Time Frame: from randomization until patient death or alive at 5 years ]
  3. Objective response rate [ Time Frame: from randomization until patient death or alive at 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707889


Locations
Show Show 46 study locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Investigators
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Study Director: Mark D. McKee, MD AbbVie
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00707889    
Obsolete Identifiers: NCT00788411
Other Study ID Numbers: M10-300
2007-007081-38 ( EudraCT Number )
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Leucovorin
Folic Acid
Bevacizumab
Fluorouracil
Oxaliplatin
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action