Back to resultsA Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Primary Purpose
Thrombosis, Cancer, Pulmonary Embolism
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Apixaban
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Thrombosis focused on measuring anticoagulant
Eligibility Criteria
Key Inclusion Criteria: Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin 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 Key Exclusion Criteria: Women who are pregnant, breastfeeding 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.
Sites / Locations
- Arizona Cancer Center
- Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
- Dana-Farber Cancer Inst
- Nevada Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- Mount Sinai School Of Medicine
- University Of Rochester
- University Of Texas Md Anderson Cancer Ctr
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Cohort 1: Placebo
Cohort 1: Apixaban, 5 mg
Cohort 1: Apixaban, 10 mg
Cohort 1: Apixaban, 20 mg
Cohort 2: Placebo
Cohort 2: Apixaban, 5 mg
Arm Description
Participants received placebo tablets once daily
Participants received apixaban as tablet, 5 mg, once daily
Participants received apixaban as tablet, 10 mg, once daily
Participants received apixaban as tablet, 20 mg, once daily
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:
A decrease in hemoglobin of 20 g/L or more or
Required transfusion of 2 or more units of packed red blood cells or whole blood, or
Occurred in a critical site
Contributed to death.
CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:
Skin hematoma
Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention
Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract
Any other bleeding type that was considered to have clinical consequences.
Secondary Outcome Measures
Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death
VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Number of Participants With All-Cause Death
Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Number of Participants With Nonfatal Pulmonary Embolism
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Number of Participants With Deep Vein Thrombosis
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Number of Participants With Distal Deep Vein Thrombosis
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Number of Participants With Proximal Deep Vein Thrombosis
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Full Information
NCT ID
NCT00320255
First Posted
April 28, 2006
Last Updated
August 11, 2016
Sponsor
Bristol-Myers Squibb
Collaborators
Ontario Clinical Oncology Group (OCOG)
1. Study Identification
Unique Protocol Identification Number
NCT00320255
Brief Title
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Official Title
A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ontario Clinical Oncology Group (OCOG)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Cancer, Pulmonary Embolism
Keywords
anticoagulant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo tablets once daily
Arm Title
Cohort 1: Apixaban, 5 mg
Arm Type
Placebo Comparator
Arm Description
Participants received apixaban as tablet, 5 mg, once daily
Arm Title
Cohort 1: Apixaban, 10 mg
Arm Type
Active Comparator
Arm Description
Participants received apixaban as tablet, 10 mg, once daily
Arm Title
Cohort 1: Apixaban, 20 mg
Arm Type
Active Comparator
Arm Description
Participants received apixaban as tablet, 20 mg, once daily
Arm Title
Cohort 2: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Cohort 2: Apixaban, 5 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
BMS-562247
Intervention Description
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets administered once daily
Primary Outcome Measure Information:
Title
Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
Description
Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:
A decrease in hemoglobin of 20 g/L or more or
Required transfusion of 2 or more units of packed red blood cells or whole blood, or
Occurred in a critical site
Contributed to death.
CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:
Skin hematoma
Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention
Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract
Any other bleeding type that was considered to have clinical consequences.
Time Frame
From first dose to 2 days following last dose of study drug
Secondary Outcome Measure Information:
Title
Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
Description
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
Description
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Time Frame
First dose to 30 days following last dose of study drug
Title
Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death
Description
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death
Description
VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With All-Cause Death
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
Description
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With Nonfatal Pulmonary Embolism
Description
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With Deep Vein Thrombosis
Description
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With Distal Deep Vein Thrombosis
Description
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants With Proximal Deep Vein Thrombosis
Description
Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Time Frame
First dose to 2 days following last dose of study drug
Title
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
Description
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time Frame
First dose to 2 days following last dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
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
Key Exclusion Criteria:
Women who are pregnant, breastfeeding
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Dana-Farber Cancer Inst
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School Of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University Of Texas Md Anderson Cancer Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 2C5
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34622445
Citation
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.
Results Reference
derived
PubMed Identifier
33337539
Citation
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.
Results Reference
derived
Learn more about this trial
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
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