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

NCT00942968 | Completed Phase 4 Results

• 2 other identifiers: FRAG-A001-401A6301095
• Study Type: interventional
• Target: 338
• Locations: 5 countries
• Sites: 42

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee

  A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of greater than or equal to (\>=) 2 gram per deciliter (g/dL), 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.

  Month 2 up to Month 6

• Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee

  A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of \>=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.

  Month 7 up to Month 12

• Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee

  VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported.

  Month 7 up to Month 12

Secondary Outcomes (10)

• Number of Participants With Investigator Identified Major Bleeding Events

  Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12

• Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee

  Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12

• Number of Participants With Fatal Bleeding Events

  Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12

• Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee

  Month 1 up to Month 12

• Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee

  Month 1 up to Month 12

Other Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Baseline (Day 1) up to Week 52

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Baseline (Day 1) up to Week 52

• Number of Participants With Abnormal Physical Examinations Findings

  Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52

Study Arms (1)

1

EXPERIMENTAL

Drug: dalteparin

Interventions

dalteparin DRUG

Daily subcutaneous injection 200IU/kg dalteparin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, age greater than or equal to 18 years of age.
• 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.
• Subjects must be newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both.
• 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.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Subjects must have a life expectancy of \>6 months.
• Subjects must have a platelet count of \>75,000 mm\^3.
• The subject must not be on any oral anticoagulant therapy for concomitant diseases.
• Subjects must have no active or serious bleeding episodes within two weeks prior to study entry.
• Subjects must be able to comply with scheduled follow-ups.

You may not qualify if:

• Subjects who have a high risk of serious bleeding (e.g., recent neurosurgery within 30 days, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.).
• Subjects who are on hemodialysis.
• Subjects who have a prior placement of a Greenfield filter or other device to prevent embolization of deep vein thromboses.
• Subjects with a known contraindication to the use of heparin (e.g., heparin-induced thrombocytopenia).
• Subjects with a known hypersensitivity to heparin, dalteparin sodium, other LMWHs or pork products.
• 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).
• Subject is pregnant or breast feeding.
• Subjects with uncontrolled hypertension characterized by a sustained systolic pressure \>170 mmHg and/or diastolic pressure \>100 mmHg.
• 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.
• Any condition that makes the subject unsuitable in the opinion of the investigator.
• Subjects with leukemia or myeloproliferative syndrome.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (42)

Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Bay Area Cancer Research Group

Pleasant Hill, California, 94523, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

University of CT Health Center

Farmington, Connecticut, 6030, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 6360, United States

Location

Georgetown University Hospital-Lombardi Cancer Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Halifax Health

Daytona Beach, Florida, 32114, United States

Location

Atlanta Institute for Medical Research

Decatur, Georgia, 30030, United States

Location

Orchard Healthcare Research Inc.

Skokie, Illinois, 60076, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Bringham and Women's Hospital

Boston, Massachusetts, 2115, United States

Location

Henry Ford Hospital K-15

Detroit, Michigan, 48202, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University, Medical Center

Stony Brook, New York, 11794, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MidDakota Clinic

Bismarck, North Dakota, 58501, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Vermont Cancer Center at Fletcher Allen Health Care

Burlington, Vermont, 5401, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

LKH Graz Univrsitatstklinik fur Innere Medizin

Graz, Austria

Location

Medizinische Universitat Innsbruck Studienambulanz Hamatologie

Innsbruck, Austria

Location

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

Linz, Austria

Location

KH der Barmherzigen Schwestern

Linz, Austria

Location

Dialysestation Landesklinkum St.Poelten

Sankt Pölten, Austria

Location

Medizinische Universitat Wien

Vienna, Austria

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Ottawa Health Research Institute

Ottawa, Ontario, Canada

Location

University Health Network-Toronto General Hospital

Toronto, Ontario, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

Location

Gelre Ziekenhuizen-Locatie Apeldoorn

Apeldoorn, Netherlands

Location

Orbis Medisch Centrum, Sittard-Geleen

Sittard-Geleen, Netherlands

Location

Hospital clinic i Provincial de Agencia de Ensayos Clinicos

Barcelona, Spain

Location

Hospital General Santa Maria del Rosell

Caragena (Murcia), Spain

Location

Hospital Virgen de la Arrixaca

El Palmar (Murcia), Spain

Location

Hospital Universitari Dr Josep Trueta

Girona, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

Dalteparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

• Gary Palmer, MD

  Medical Affairs, Eisai, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 21, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 18, 2024
• Results First Posted: February 24, 2017

Record last verified: 2024-04

Locations

CA (8); ES (5); US (21); NL (2); AU (6)