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
3 other identifiers
interventional
300
1 country
18
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2015
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedStudy Start
First participant enrolled
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2019
CompletedResults Posted
Study results publicly available
December 24, 2019
CompletedAugust 4, 2020
June 1, 2019
2.4 years
October 22, 2015
October 21, 2019
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
6 Month Bleeding Rate
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.
Up to 6 months
Secondary Outcomes (2)
Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed
Up to 6 months
Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
Up to 3 months post-treatment
Study Arms (2)
Arm I (apixaban)
EXPERIMENTALPatients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
Arm II (dalteparin)
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed acute lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis
- 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 \>= 60 days
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Obtained =\< 30 days prior to randomization: Platelet count \>= 50,000/mm\^3
- Obtained =\< 30 days prior to randomization: Alanine aminotransferase (ALT) or aspartate transaminase (AST) =\< 3 x upper limit of normal (ULN)
- Obtained =\< 30 days prior to randomization: International normalized ratio (INR) =\< 1.6 (if not taking anticoagulant therapy)
- Obtained =\< 30 days prior to randomization: Calculated creatinine clearance must be \>= 30 ml/min using the Cockcroft-Gault formula
- Negative serum or urine pregnancy test done =\< 24 hours prior to randomization, for women of childbearing potential only; note: a women 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 complete questionnaire(s) by themselves or with assistance
- Ability to provide informed written consent
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
You may not qualify if:
- 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; highly effective methods of contraception have a failure rate of \< 1% when used consistently and correctly
- At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:
- HIGHLY EFFECTIVE METHODS OF CONTRACEPTION
- 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 since they will not be receiving study drug
- IUDs, such as ParaGard
- Tubal ligation
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, 03106, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Related Publications (2)
McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.
PMID: 31630479DERIVEDMcBane Ii R, Loprinzi CL, Ashrani A, Perez-Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Le-Rademacher JG, Wysokinski WE. Apixaban and dalteparin in active malignancy associated venous thromboembolism. The ADAM VTE Trial. Thromb Haemost. 2017 Oct 5;117(10):1952-1961. doi: 10.1160/TH17-03-0193. Epub 2017 Aug 24.
PMID: 28837207DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert D. McBane, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Robert McBane
Academic and Community Cancer Research United
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 23, 2015
Study Start
November 20, 2015
Primary Completion
April 2, 2018
Study Completion
December 24, 2019
Last Updated
August 4, 2020
Results First Posted
December 24, 2019
Record last verified: 2019-06