Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00942968
First received: July 16, 2009
Last updated: June 30, 2014
Last verified: April 2012
  Purpose

The purpose of this study is to determine the long term tolerability and safety of dalteparin in subjects with cancer.


Condition Intervention Phase
Cancer
Drug: dalteparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FRAG-A001-401: Dalteparin Sodium Injection (Fragmin), Multicenter, Open-Label, Single-arm, Long Term (52 Weeks) Study for Understanding the Safety and Efficacy in Subjects With Malignancies and Symptomatic Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Physical examinations, lab evaluations, creatine clearance, electrocardiograms, adverse events, imaging (computed tomography, magnetic resonance imaging, ultrasound). [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 338
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalteparin
Daily subcutaneous injection 200IU/kg dalteparin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects, age ≥ 18 years of age.
  2. Females should be either of non-childbearing potential as a result of surgery, radiation therapy, menopause (one year post onset), or of childbearing potential and willing to adhere to an acceptable method of pregnancy prevention.
  3. Subjects must be newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both.
  4. Subjects must have active malignancy defined as a diagnosis of cancer (excluding basal cell or squamous cell carcinoma of the skin) within six months before enrollment, having received any treatment for cancer within the previous six months, or having documented recurrent or metastatic cancer.
  5. Prior to enrollment, subjects must not have received therapeutic doses of anticoagulant therapy (including low molecular weight heparin [LMWH]) for > 48 hours (or > 4 doses within 48 hours).
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  7. Subjects must have a life expectancy of > 6 months.
  8. Subjects must have a platelet count of > 75,000 mm^3.
  9. The subject must not be on any oral anticoagulant therapy for concomitant diseases.
  10. Subjects must have no active or serious bleeding episodes within two weeks prior to study entry.
  11. Subjects must be able to comply with scheduled follow-ups.

Exclusion Criteria:

  1. Subjects who have a high risk of serious bleeding (e.g., recent neurosurgery within 30 days, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.).
  2. Subjects who are on hemodialysis.
  3. Subjects who have a prior placement of a Greenfield filter or other device to prevent embolization of deep vein thromboses.
  4. Subjects with a known contraindication to the use of heparin (e.g., heparin-induced thrombocytopenia).
  5. Subjects with a known hypersensitivity to heparin, dalteparin sodium, other LMWHs or pork products.
  6. Subjects who are currently participating in another clinical trial involving anticoagulation therapy (with the exception of acetylsalicylic acid (ASA) in the 30 days prior to study entry, or who are actively using any investigational drugs/treatments 30 days prior to study entry involving anticoagulation therapy (with the exception of ASA , t.i.d).
  7. Subject is pregnant or breast feeding.
  8. Subjects with uncontrolled hypertension characterized by a sustained systolic pressure > 170 mmHg and/or diastolic pressure > 100 mmHg.
  9. Subjects with a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the subject's ability to complete the study.
  10. Any condition that makes the subject unsuitable in the opinion of the investigator.
  11. Subjects with leukemia or myeloproliferative syndrome.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942968

  Hide Study Locations
Locations
United States, Arizona
Arizona Cancer Center
Tuscon, Arizona, United States, 85719
United States, California
Bay Area Cancer Research Group
Pleasant Hill, California, United States, 94523
Harbor - UCLA Medical Center
Torrance, California, United States, 90509
United States, Connecticut
University of CT Health Center
Farmington, Connecticut, United States, 06030
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Georgetown University Hospital - Lombardi Cancer Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Halifax Health
Daytona Beach, Florida, United States, 32114
United States, Georgia
Atlanta Institute for Medical Research
Decatur, Georgia, United States, 30030
United States, Illinois
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60076
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Bringham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital K-15
Detroit, Michigan, United States, 48202
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Stony Brook University, Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, North Dakota
MidDakota Clinic
Bismarck, North Dakota, United States, 58501
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Vermont
Vermont Cancer Center at Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Austria
LKH Graz Univrsitatstklinik fur Innere Medizin
Graz, Austria
Medizinische Universitat Innsbruck Studienambulanz Hamatologie
Innsbruck, Austria
KH der Barmherzigen Schwestern
Linz, Austria
KH d. Elizabethinen Linz GmbH Servicestelle fur klin. Studien und Universitare Angelegenheiten
Linz, Austria
Dialysestation Landesklinkum St.Poelten
St. Poelten, Austria
Medizinische Universitat Wien
Vienna, Austria
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2H7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 8L6
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Netherlands
Gelre Ziekenhuizen/Locatie Apeldoorn
Apeldoorn, Netherlands
Orbis Medisch Centrum, Sittard-Geleen
Sittard-Geleen, Netherlands
Spain
Hospital clinic i Provincial de Agencia de Ensayos Clinicos
Barcelona, Spain
Hospital General Santa Maria del Rosell
Caragena (Murcia), Spain
Hospital Virgen de la Arrixaca
El Palmar (Murcia), Spain
Hospital Universitari Dr Josep Trueta
Girona, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Gary Palmer, MD Medical Affairs, Eisai, Inc
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00942968     History of Changes
Other Study ID Numbers: FRAG-A001-401, 2008-005236-32
Study First Received: July 16, 2009
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Venous Thromboembolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014