Heart and Blood Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Thrombosis

Pulmonary Embolism

Embolism

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Embolism and Thrombosis

Vascular Diseases

Lung Diseases

Respiratory Tract Diseases

Anticoagulants

All Drugs and Chemicals

Fibrinolytic Agents

Anti-Infective Agents

Amino Acids

Apixaban

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Heparin

Calcium heparin

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.

Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.

Questionnaire Administration

Robert McBane

This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism.

ADAM-VTE

PRIMARY OBJECTIVES:

I. Any episode of major bleeding including fatal bleeding.

SECONDARY OBJECTIVES:

I. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism.

II. Any episode of major bleeding including fatal bleeding or any episode of clinically relevant non-major bleeding.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.

ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC) once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.

After completion of study treatment, patients are followed up at 3 months.

Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism

A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism

The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.

A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.

Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE).

National Cancer Institute (NCI)

Academic and Community Cancer Research United

Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.

Arm A (Apixaban)

Arm B (Dalteparin)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.

ECOG Performance Status

Robert D. McBane, M.D.

6 Month Bleeding Rate

Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed

Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism	NCT02585713	Cerebral Vein T... Deep Vein Throm... Gonadal Thrombo... Hepatic Thrombo... Malignant Neopl... Mesenteric Thro... Metastatic Mali... Portal Vein Thr... Pulmonary Embol... Renal Vein Thro... Splenic Thrombo... Venous Thromboe...	Apixaban Dalteparin Questionnaire A...	18 Years -	Academic and Community Cancer Research United
Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism	NCT02585713	Cerebral Vein T... Deep Vein Throm... Gonadal Thrombo... Hepatic Thrombo... Malignant Neopl... Mesenteric Thro... Metastatic Mali... Portal Vein Thr... Pulmonary Embol... Renal Vein Thro... Splenic Thrombo... Venous Thromboe...	Apixaban Dalteparin Questionnaire A...	18 Years -	Academic and Community Cancer Research United

Spots Global Cancer Trial Database for splenic thrombosis