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Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy

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ClinicalTrials.gov Identifier: NCT03080883
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Academic and Community Cancer Research United

Brief Summary:
This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related venous thrombosis in cancer patients who have completed anticoagulation therapy. Apixaban may help in prevention by blocking some of the enzymes needed for venous thrombosis.

Condition or disease Intervention/treatment Phase
Cerebral Vein Thrombosis Deep Vein Thrombosis Malignant Neoplasm Metastatic Malignant Neoplasm Pulmonary Embolism Splanchnic Vein Thrombosis Drug: Apixaban Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. The proportion of patients who experienced at least one such bleeding event within 6 months of beginning treatment.

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

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive lower dose apixaban orally (PO) twice daily (BID) for 365 days.

GROUP II: Patients receive higher dose apixaban PO BID for 365 days.

After completion of study treatment, patients are followed up for 12 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Group I (lower dose apixaban)
Patients receive lower dose apixaban PO BID for 365 days.
Drug: Apixaban
Given PO
Other Names:
  • BMS-562247
  • BMS-562247-01
  • Eliquis

Experimental: Group II (higher dose apixaban)
Patients receive higher dose apixaban PO BID for 365 days.
Drug: Apixaban
Given PO
Other Names:
  • BMS-562247
  • BMS-562247-01
  • Eliquis




Primary Outcome Measures :
  1. Proportion of patients who experience at least one bleeding event [ Time Frame: Up to 12 months ]
    Patients will be analyzed according to the drug they received. The analysis of major bleeding plus clinically relevant nonmajor bleeding events will primarily focus on those events which occurred during treatment or within 7 days of treatment discontinuation. Major bleeding events observed later will be described separately. The difference in the incidences of the combined endpoint at 6 months and at 12 months between treatment arms will be estimated along with a 95% confidence interval.


Secondary Outcome Measures :
  1. Proportion of patients who experienced at least one bleeding event [ Time Frame: Up to 6 months ]
    Will estimate the difference in proportion of patients who experience at least one bleeding event (i.e. the primary endpoint) within 6 months of beginning treatment across the two study arms. As with the primary analysis, a 95% confidence interval will be calculated for the difference between arms.

  2. Venous thromboembolism recurrence [ Time Frame: Up to 12 months ]
    The time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) outcome will be analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed acute index (original venous thrombotic) event: lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis for which the patient has received >= 180 days (but =< 365 days) of anticoagulant therapy prior to registration; the date, imaging modality, and location of index event will be required; the date of initiation and specific type of anticoagulants used will also be required
  • Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; Note: non-melanoma skin cancer does not meet the cancer requirement
  • Life expectancy >= 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
  • Hemoglobin >= 8 g/dL obtained =< 30 days prior to registration
  • Platelet count >= 50,000/mm^3 obtained =< 30 days prior to registration
  • Alanine aminotransferase (ALT) or aspartate transaminase (AST) =< 3 x upper limit of normal (ULN) obtained =< 30 days prior to registration
  • Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula obtained =< 30 days prior to registration
  • Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only;

    • Note: a woman of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal; menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes
  • Ability to provide informed written consent
  • Willing to undergo monthly follow-up assessment, either in person at the enrolling institution or by telephone

Exclusion Criteria:

  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception

      • Note: women of child bearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 33 days after finishing the last dose
      • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 93 days after finishing the last dose
      • Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however they must still undergo pregnancy testing as described in this section; note: investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; at a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:

        • Male condoms with spermicide
        • Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject?s WOCBP partner
        • Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception
        • IUDs, such as ParaGard
        • Tubal ligation
        • Vasectomy
        • Complete abstinence

          • Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence
  • Active major bleeding
  • Severe hypersensitivity reaction to apixaban (e.g., anaphylactic reactions)
  • Current use of strong CYP3A4 inducers or inhibitors

    • NOTE: patients may be eligible if they transition to an alternative agent or are able to stop CYP3A4 inducer or inhibitor
  • Current use of thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
  • Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
  • Documented venous thromboembolism while on therapeutic anticoagulation (?anticoagulation failure?)
  • Mechanical heart valve
  • Documented hemorrhagic tendencies (e.g., hemophilia)
  • Bacterial endocarditis
  • Any of the following conditions:

    • Intracranial bleeding =< 6 months prior to randomization
    • Intraocular bleeding =< 6 months prior to randomization
    • Gastrointestinal bleeding and/or endoscopically proven ulcer =< 6 months prior to randomization
    • Head trauma or major trauma =< 1 month prior to randomization
    • Neurosurgery =< 2 weeks prior to randomization
    • Major surgery =< 1 week prior to randomization
    • Gross hematuria at the time of randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080883


  Show 29 Study Locations
Sponsors and Collaborators
Academic and Community Cancer Research United
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert D McBane Academic and Community Cancer Research United

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT03080883     History of Changes
Other Study ID Numbers: ACCRU-SC-1601
NCI-2017-00325 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACCRU-SC-1601 ( Other Identifier: Academic and Community Cancer Research United )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Venous Thrombosis
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action