Clinical trial NCT00942968: Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-21
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
timeFrame: Month 2 up to Month 6
measure: Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
timeFrame: Month 7 up to Month 12
measure: Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
timeFrame: Month 7 up to Month 12
Secondary outcomes:
measure: Number of Participants With Investigator Identified Major Bleeding Events
timeFrame: 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
measure: Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
timeFrame: 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
measure: Number of Participants With Fatal Bleeding Events
timeFrame: 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
measure: Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee
timeFrame: Month 1 up to Month 12
measure: Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
timeFrame: Month 1 up to Month 12
measure: Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
timeFrame: 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
measure: Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
timeFrame: 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
measure: Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
timeFrame: 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
measure: Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
timeFrame: Month 1 up to Month 12
measure: Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee
timeFrame: Month 1 up to Month 12
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Week 52
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline (Day 1) up to Week 52
measure: Number of Participants With Abnormal Physical Examinations Findings
timeFrame: Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52
measure: Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Farmington
country: United States
facility: University of CT Health Center
state: Connecticut
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital-Lombardi Cancer Ctr
state: District of Columbia
city: Daytona Beach
country: United States
facility: Halifax Health
state: Florida
city: Decatur
country: United States
facility: Atlanta Institute for Medical Research
state: Georgia
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Boston
country: United States
facility: Bringham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital K-15
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University, Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: MidDakota Clinic
state: North Dakota
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: Vermont Cancer Center at Fletcher Allen Health Care
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Graz
country: Austria
facility: LKH Graz Univrsitatstklinik fur Innere Medizin
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck Studienambulanz Hamatologie
city: Linz
country: Austria
facility: KH d. Elizabethinen Linz GmbH Servicestelle fur klin. Studien und Universitare Angelegenheiten
city: Linz
country: Austria
facility: KH der Barmherzigen Schwestern
city: St. Poelten
country: Austria
facility: Dialysestation Landesklinkum St.Poelten
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network-Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen-Locatie Apeldoorn
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medisch Centrum, Sittard-Geleen
city: Barcelona
country: Spain
facility: Hospital clinic i Provincial de Agencia de Ensayos Clinicos
city: Caragena (Murcia)
country: Spain
facility: Hospital General Santa Maria del Rosell
city: El Palmar (Murcia)
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Girona
country: Spain
facility: Hospital Universitari Dr Josep Trueta
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Medical Affairs, Eisai, Inc
name: Gary Palmer, MD
role: STUDY_DIRECTOR
References: