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

NCT ID: NCT00942968

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-06-30

Brief Summary

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

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

dalteparin

Intervention Type: DRUG

Daily subcutaneous injection 200IU/kg dalteparin

Interventions

dalteparin

Daily subcutaneous injection 200IU/kg dalteparin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Gary Palmer, MD

Role: STUDY_DIRECTOR

Medical Affairs, Eisai, Inc

Locations

Arizona Cancer Center

Tucson, Arizona, United States

Bay Area Cancer Research Group

Pleasant Hill, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

University of CT Health Center

Farmington, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Georgetown University Hospital-Lombardi Cancer Ctr

Washington D.C., District of Columbia, United States

Halifax Health

Daytona Beach, Florida, United States

Atlanta Institute for Medical Research

Decatur, Georgia, United States

Orchard Healthcare Research Inc.

Skokie, Illinois, United States

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Bringham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Hospital K-15

Detroit, Michigan, United States

University of Rochester Medical Center

Rochester, New York, United States

Stony Brook University, Medical Center

Stony Brook, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

MidDakota Clinic

Bismarck, North Dakota, United States

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Vermont Cancer Center at Fletcher Allen Health Care

Burlington, Vermont, United States

University of Virginia

Charlottesville, Virginia, United States

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

Sankt Pölten, , Austria

Medizinische Universitat Wien

Vienna, , Austria

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

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

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

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

Countries

United States; Austria; Canada; Netherlands; Spain

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=FRAG-A001-401&StudyName=Daleparin%20Sodium%20Injection%20%28fragmin%20%28registered%29%29%2C%20Multicenter%2C%20Open%20Label%2C%20Single-arm%2C%20Long%20Term%20%2852%20Weeks%29%20Study%20For%20Underatnding%20Safety%20And%20Efficacy%20In%20Subjects%20With%20Malignancies%20And%20Symptomatic%20Venous%20Thromboembolism

To obtain contact information for a study center near you, click here.

Other Identifiers

A6301095

Identifier Type: OTHER

Identifier Source: secondary_id

FRAG-A001-401

Identifier Type: -

Identifier Source: org_study_id