A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
NCT ID: NCT00320255
Last Updated: 2016-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2006-06-30
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Cohort 1: Placebo
Participants received placebo tablets once daily
Placebo
Oral tablets administered once daily
Cohort 1: Apixaban, 5 mg
Participants received apixaban as tablet, 5 mg, once daily
Apixaban
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
Cohort 1: Apixaban, 10 mg
Participants received apixaban as tablet, 10 mg, once daily
Apixaban
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
Cohort 1: Apixaban, 20 mg
Participants received apixaban as tablet, 20 mg, once daily
Apixaban
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
Cohort 2: Placebo
Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
Placebo
Oral tablets administered once daily
Cohort 2: Apixaban, 5 mg
Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
Apixaban
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
Interventions
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Apixaban
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
Placebo
Oral tablets administered once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
* Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
* Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law
Exclusion Criteria
* History of deep vein thrombosis or pulmonary embolism
* Active bleeding or at high risk of bleeding
* Metastatic brain cancer
* Familial bleeding diathesis
* Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
* Expected survival \<6 months or an Eastern Cooperative Oncology Group performance status ≥3.
* Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
* Uncontrolled hypertension (systolic blood pressure \>200 mm Hg and/or diastolic blood pressure \>110 mm Hg
* Coagulopathy (international normalized ratio \>1.5 or platelet count \<100\*10\^9/L) if not yet receiving chemotherapy or \<50\*10\^9/L if receiving chemotherapy). Platelet count must have been \>100\*10\^9/L before starting study medication
* One or more of the following: alanine aminotransferase \>3 times the upper limit of normal (ULN), total bilirubin \>2\*ULN, or calculated creatinine clearance \<30 mL/min.
18 Years
90 Years
ALL
No
Sponsors
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Ontario Clinical Oncology Group (OCOG)
OTHER
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States
Dana-Farber Cancer Inst
Boston, Massachusetts, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai School Of Medicine
New York, New York, United States
University Of Rochester
Rochester, New York, United States
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States
Local Institution
Hamilton, Ontario, Canada
Local Institution
London, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Countries
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References
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Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.
Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
Related Links
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Investigator Inquiry form
Other Identifiers
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CV185-027
Identifier Type: -
Identifier Source: org_study_id
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