Apixaban in Preventing Secondary Cancer Related Blood Clots in Cancer Patients Who Have Completed Anticoagulation Therapy



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 14, 2017
End Date:May 1, 2023

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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

This randomized phase III trial studies the best dose of apixaban and how well it works in
preventing secondary cancer related blood clots in cancer patients who have completed
anticoagulation therapy. Apixaban may stop the clotting of blood by blocking some of the
enzymes needed for blood clotting.

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.

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
We found this trial at
21
sites
Iowa City, Iowa 52242
Principal Investigator: Usha S. Perepu
Phone: 319-353-6347
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: John C. Krauss
Phone: 734-763-4457
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Chapel Hill, North Carolina 27599
Principal Investigator: Micah J. Mooberry
Phone: 919-966-4432
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Chapel Hill, NC
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Ewa M. Wysokinska
Phone: 919-668-6716
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Edgewood, Kentucky 41017
Principal Investigator: Colleen M. Darnell
Phone: 859-301-4046
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Evanston, Illinois 60201
Principal Investigator: Alfonso J. Tafur
Phone: 224-251-4705
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Grand Forks, North Dakota 58201
Principal Investigator: Keith Swanson
Phone: 507-284-4565
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501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
Principal Investigator: James M. Granfortuna
Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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Greensboro, NC
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200 Technology Drive
Hooksett, New Hampshire 03106
603-622-6484
Principal Investigator: Douglas J. Weckstein
New Hampshire Oncology - Hematology, PA - Hooksett New Hampshire Oncology-Hematology, PA (NHOH) was founded...
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Prakash Vishnu
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Monic R. Drescher
Phone: 603-650-2967
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Marshfield, Wisconsin 54449
Principal Investigator: Chady A. Leon
Phone: 715-387-5416
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Krishna Gundabolu
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Principal Investigator: Nadia Q. Rehman
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Pinehurst, North Carolina 28374
Principal Investigator: Charles S. Kuzma
Phone: 910-715-3500
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Rochester, Minnesota 55905
Principal Investigator: Robert D. McBane
Phone: 507-266-3964
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Tanya M. Wildes
Phone: 314-362-7249
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis Park, Minnesota 55416
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1555
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Leslie J. Padrnos
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: Vamsi K. Vasireddy
Phone: 217-383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Wichita, Kansas 67214
Principal Investigator: Shaker R. Dakhil
Phone: 316-262-4467
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