CompletedNCT00320255Updated Aug 16, 2016Results posted

A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer

A Phase 2 interventional study of Apixaban and Placebo in Thrombosis, Cancer and Pulmonary Embolism, sponsored by Bristol-Myers Squibb. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-16.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study 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.

Conditions studied

Thrombosis
Cancer
Pulmonary Embolism

Browse trials for

Keywords

anticoagulant

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 130 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
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.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 130 participants (actual)

Study arms

Placebo comparator
Cohort 1: Placebo
Participants received placebo tablets once daily
Drug: Placebo
Placebo comparator
Cohort 1: Apixaban, 5 mg
Participants received apixaban as tablet, 5 mg, once daily
Drug: Apixaban
Active comparator
Cohort 1: Apixaban, 10 mg
Participants received apixaban as tablet, 10 mg, once daily
Drug: Apixaban
Active comparator
Cohort 1: Apixaban, 20 mg
Participants received apixaban as tablet, 20 mg, once daily
Drug: Apixaban
Placebo comparator
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.
Drug: Placebo
Active comparator
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.
Drug: Apixaban

Interventions

DrugApixaban
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
Also known as: BMS-562247
DrugPlacebo
Oral tablets administered once daily

What researchers measure

Primary outcomes

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.
Time frame: From first dose to 2 days following last dose of study drug

Secondary outcomes

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.
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 30 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With All-Cause Death
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug
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.
Time frame: First dose to 2 days following last dose of study drug

Results

Posted Aug 16, 2016

Participant flow

Participant flow — Overall Study
Milestone	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
Started	30	32	30	33	2	3
Received treatment	29	32	29	32	2	3
Completed	19	25	24	25	2	3
Not completed	11	7	6	8	0	0
Withdrew: Lack of efficacy	1	0	0	0	0	0
Withdrew: Adverse event	5	2	3	2	0	0
Withdrew: Withdrawal by subject	1	2	2	4	0	0
Withdrew: Poor compliance/noncompliance	1	1	0	1	0	0
Withdrew: No longer meets study criteria	0	0	0	1	0	0
Withdrew: Other	3	2	1	0	0	0

Outcome measures

SecondaryNumber 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.

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
Participants	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
Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death	4 (3.9 to 31.7)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	1 (0.1 to 16.2)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber 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.

Time frame:: First dose to 30 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
Participants	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
Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death	3 (2.2 to 27.4)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death
Participants	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
Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death	4 (3.9 to 31.7)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	1 (0.1 to 16.2)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber 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.

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death
Participants	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
Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death	3 (2.2 to 27.4)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber of Participants With All-Cause Death

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With All-Cause Death
Participants	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
Number of Participants With All-Cause Death	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber 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.

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
Participants	Cohort 1: Placebo	Cohort 1: Apixaban, 5 mg	Cohort 1: Apixaban, 10 mg	Cohort 1: Apixaban, 20 mg	Cohort 2: Placebo	Cohort 2: Apixiban, 5 mg
Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)	1 (0.1 to 17.8)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber 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.

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Nonfatal Pulmonary Embolism
Participants	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
Number of Participants With Nonfatal Pulmonary Embolism	1 (0.1 to 17.8)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber 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.

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Deep Vein Thrombosis
Participants	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
Number of Participants With Deep Vein Thrombosis	4 (3.9 to 31.7)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	1 (0.1 to 16.2)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber of Participants With Distal Deep Vein Thrombosis

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Distal Deep Vein Thrombosis
Participants	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
Number of Participants With Distal Deep Vein Thrombosis	1 (0.1 to 17.8)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber of Participants With Proximal Deep Vein Thrombosis

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Proximal Deep Vein Thrombosis
Participants	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
Number of Participants With Proximal Deep Vein Thrombosis	3 (2.2 to 27.4)	0 (0.0 to 10.9)	0 (0.0 to 11.9)	0 (0.0 to 10.9)	0 (NA to NA)	0 (NA to NA)

SecondaryNumber 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.

Time frame:: First dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
Participants	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
Deaths	2	1	0	0	0	0
SAEs	9	6	3	5	1	0
Bleeding AEs	6	15	11	12	1	2
Discontinuations due to AEs	7	4	4	4	1	0

PrimaryNumber 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.

Time frame:: From first dose to 2 days following last dose of study drug
Reported as:: Number · Participants

Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
Participants	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
Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding	1 (0.1 to 17.8)	1 (0.1 to 16.2)	1 (0.1 to 17.8)	4 (3.5 to 29.0)	2 (NA to NA)	3 (NA to NA)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1: Placebo	—	9/29 (31%)	24/29 (82.8%)
Cohort 1: Apixaban, 5 mg	—	6/32 (18.8%)	28/32 (87.5%)
Cohort 1: Apixaban, 10 mg	—	3/29 (10.3%)	24/29 (82.8%)
Cohort 1: Apixaban, 20 mg	—	5/32 (15.6%)	30/32 (93.8%)
Cohort 2: Placebo	—	1/2 (50%)	2/2 (100%)
Cohort : Apixaban, 5 mg	—	0/3 (0%)	3/3 (100%)

Most frequent serious events

Showing 10 of 37

Most frequent serious events
Event	Cohort 1: Placebo	Cohort 1: Apixaban, 5 mg	Cohort 1: Apixaban, 10 mg	Cohort 1: Apixaban, 20 mg	Cohort 2: Placebo	Cohort : Apixaban, 5 mg
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	2/29	0/32	0/29	0/32	1/2	0/3
InfectionInfections and infestations	3/29	1/32	1/29	0/32	0/2	0/3
Febrile neutropeniaBlood and lymphatic system disorders	2/29	0/32	0/29	0/32	0/2	0/3
DehydrationMetabolism and nutrition disorders	1/29	0/32	0/29	0/32	0/2	0/3
Abdominal painGastrointestinal disorders	1/29	0/32	0/29	0/32	0/2	0/3
HyperglycaemiaMetabolism and nutrition disorders	1/29	0/32	0/29	1/32	0/2	0/3
DeathGeneral disorders	1/29	0/32	0/29	0/32	0/2	0/3
Duodenal ulcerGastrointestinal disorders	1/29	0/32	0/29	0/32	0/2	0/3
NauseaGastrointestinal disorders	1/29	0/32	0/29	0/32	0/2	0/3
SepsisInfections and infestations	0/29	0/32	1/29	0/32	0/2	0/3

Most frequent other events

Showing 10 of 86

Most frequent other events
Event	Cohort 1: Placebo	Cohort 1: Apixaban, 5 mg	Cohort 1: Apixaban, 10 mg	Cohort 1: Apixaban, 20 mg	Cohort 2: Placebo	Cohort : Apixaban, 5 mg
DiarrhoeaGastrointestinal disorders	4/29	5/32	7/29	10/32	2/2	1/3
InsomniaPsychiatric disorders	3/29	2/32	1/29	2/32	2/2	1/3
EpistaxisRespiratory, thoracic and mediastinal disorders	4/29	8/32	4/29	7/32	1/2	2/3
Pain in extremityMusculoskeletal and connective tissue disorders	2/29	3/32	5/29	4/32	1/2	1/3
Abdominal painGastrointestinal disorders	1/29	2/32	0/29	0/32	1/2	1/3
ConstipationGastrointestinal disorders	5/29	5/32	2/29	5/32	1/2	1/3
Skin discolourationSkin and subcutaneous tissue disorders	0/29	0/32	0/29	1/32	1/2	0/3
CoughRespiratory, thoracic and mediastinal disorders	2/29	1/32	2/29	1/32	1/2	1/3
Pilonidal cystInfections and infestations	0/29	0/32	0/29	0/32	1/2	0/3
Rectal abscessInfections and infestations	0/29	0/32	0/29	0/32	1/2	0/3

Baseline characteristics

All participants who were randomized to receive treatment

Age, Customized
Age, Customized(Participants)	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	Total
Younger than 65 years	17	28	19	17	1	3	85
65 years and older but younger than 75 years	8	4	9	8	1	0	30
75 years and older	5	0	2	8	0	0	15

Sex: Female, Male
Sex: Female, Male(Participants)	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	Total
Female	15	17	17	13	0	2	64
Male	15	15	13	20	2	1	66

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	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	Total
White	27	27	26	25	2	3	110
Black/African American	0	2	1	3	0	0	6
Asian	2	2	1	2	0	0	7
Native Hawaiian or other Pacific Islander	0	1	0	0	0	0	1
Other	1	0	2	3	0	0	6

Study locations

14 sites

Arizona Cancer Center
Tucson, Arizona 85724, United States
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California 90033, United States
Dana-Farber Cancer Inst
Boston, Massachusetts 02115, United States
Nevada Cancer Institute
Las Vegas, Nevada 89135, United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10021, United States
Mount Sinai School Of Medicine
New York, New York 10029, United States
University Of Rochester
Rochester, New York 14642, United States
University Of Texas Md Anderson Cancer Ctr
Houston, Texas 77030, United States
Local Institution
Hamilton, Ontario L8V 2C5, Canada
Local Institution
London, Ontario N6A 4L6, Canada
Local Institution
Toronto, Ontario M4N 3M5, Canada
Local Institution
Toronto, Ontario M5G 2M9, Canada
Local Institution
Montreal, Quebec H1T 2M4, Canada
Local Institution
Montreal, Quebec H3G 1A4, Canada

References and documents

Publications

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. PubMed 34622445 ↗
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. PubMed 33337539 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00320255
Lead sponsor: Bristol-Myers Squibb
Collaborators: Ontario Clinical Oncology Group (OCOG)
Responsible party: Sponsor
First posted: May 3, 2006
Start date: Jun 2006
Primary completion: Jan 2009
Completion: Jan 2009
Results posted: Aug 16, 2016
Last update: Aug 16, 2016

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pulmonary Embolism→

Other studies from this sponsor