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Completed

NCT Number: NCT00320255

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

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.

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Key information

Conditions

Thrombosis Cancer Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apixaban

Drug

Oral tablets administered once daily in 5-, 10-, or 20-mg dose

Other names: BMS-562247

Placebo

Drug

Oral tablets administered once daily

Primary outcomes

  1. Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding

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

    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 outcomes

  1. Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death

    Time frame: First dose to 2 days following last dose of study drug

    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.

  2. Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death

    Time frame: First dose to 30 days following last dose of study drug

    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.

  3. Number 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

    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.

  4. Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death

    Time frame: First dose to 2 days following last dose of study drug

    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.

  5. Number of Participants With All-Cause Death

    Time frame: First dose to 2 days following last dose of study drug

  6. Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)

    Time frame: First dose to 2 days following last dose of study drug

    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.

  7. Number of Participants With Nonfatal Pulmonary Embolism

    Time frame: First dose to 2 days following last dose of study drug

    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.

  8. Number of Participants With Deep Vein Thrombosis

    Time frame: First dose to 2 days following last dose of study drug

    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.

  9. Number of Participants With Distal Deep Vein Thrombosis

    Time frame: First dose to 2 days following last dose of study drug

    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.

  10. Number of Participants With Proximal Deep Vein Thrombosis

    Time frame: First dose to 2 days following last dose of study drug

    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.

  11. Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs

    Time frame: First dose to 2 days following last dose of study drug

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ontario Clinical Oncology Group (OCOG)

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 3, 2006
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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