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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
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Age
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Protocol IDs
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Phase II
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Treatment
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Approved-not yet active
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Over 18
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Pharmaceutical / Industry
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M10-300
EudraCT: 2007-007081-38, NCT00707889
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Trial Description
Summary To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer. Eligibility 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 PTT < 1.5 x ULN and 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 bevacizumab or a tyrosine kinase inhibitor targeting VEGF or PDGF. Lead-in cohort only: Prior treatment with bevacizumab will be allowed, but not within 7 weeks of ABT-869 administration.
- Subject has received prior treatment with oxaliplatin in the metastatic setting.
- Subject has had major surgery within 28 days of Study Day 1.
- Subject has had radiotherapy within 14 days of Study Day 1.
- The subject has a history of hypersensitivity to recombinant murine monoclonal antibodies, oxaliplatin or other platinum-containing compounds, fluorouracil, or folinic acid.
- The subject has a known intolerance to bevacizumab.
- The 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 Contact Information
Trial Lead Organizations/Sponsors Abbott Laboratories Genentech Incorporated
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00707889
Information obtained from ClinicalTrials.gov on September 11, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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