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

Condition(s) targeted: Cancer

Intervention: dalteparin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Gary Palmer, MD, Study Director, Affiliation: Medical Affairs, Eisai, Inc

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

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Physical examinations, lab evaluations, creatine clearance, electrocardiograms, adverse events, imaging (computed tomography, magnetic resonance imaging, ultrasound).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male and female subjects, age greater than or equal to 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.

LKH Graz Univrsitatstklinik fur Innere Medizin, Graz, Austria

Medizinische Universitat Innsbruck Studienambulanz Hamatologie, Innsbruck, Austria

KH d. Elizabethinen Linz GmbH Servicestelle fur klin. Studien und Universitare Angelegenheiten, Linz, Austria

KH der Barmherzigen Schwestern, Linz, Austria

Dialysestation Landesklinkum St.Poelten, St. Poelten, Austria

Medizinische Universitat Wien, Vienna, Austria

Gelre Ziekenhuizen-Locatie Apeldoorn, Apeldoorn, Netherlands

Orbis Medisch Centrum, Sittard-Geleen, Sittard-Geleen, Netherlands

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

University of Alberta, Edmonton, Alberta, Canada

Arizona Cancer Center, Tuscon, Arizona 85719, United States

Vancouver General Hospital, Vancouver, British Columbia, Canada

Bay Area Cancer Research Group, Pleasant Hill, California 94523, United States

Harbor-UCLA Medical Center, Torrance, California 90509, United States

University of CT Health Center, Farmington, Connecticut 6030, United States

Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut 6360, United States

Georgetown University Hospital-Lombardi Cancer Ctr, Washington, District of Columbia 20007, United States

Halifax Health, Daytona Beach, Florida 32114, United States

Atlanta Institute for Medical Research, Decatur, Georgia 30030, United States

Orchard Healthcare Research Inc., Skokie, Illinois 60076, United States

James Graham Brown Cancer Center, Louisville, Kentucky 40202, United States

Bringham and Women's Hospital, Boston, Massachusetts 2115, United States

Henry Ford Hospital K-15, Detroit, Michigan 48202, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

Stony Brook University, Medical Center, Stony Brook, New York 11794, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

MidDakota Clinic, Bismarck, North Dakota 58501, United States

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada

London Health Sciences Centre, London, Ontario, Canada

Ottawa Health Research Institute, Ottawa, Ontario, Canada

University Health Network-Toronto General Hospital, Toronto, Ontario, Canada

Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania 19106, United States

Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada

Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada

MD Anderson Cancer Center, Houston, Texas 77030, United States

University of Utah, Salt Lake City, Utah 84132, United States

Vermont Cancer Center at Fletcher Allen Health Care, Burlington, Vermont 5401, United States

University of Virginia, Charlottesville, Virginia 22908, United States

Starting date: June 2009
Last updated: January 22, 2015