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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Gary Palmer, MD

Investigator Role:

Study Director

Investigator Affiliation:

Medical Affairs, Eisai, Inc

Authority:

United States: Food and Drug Administration

Study ID:

FRAG-A001-401

NCT ID:

NCT00942968

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Cancer
  • Venous Thromboembolism

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
MD Anderson Cancer CenterHouston, Texas  77030-4096
James Graham Brown Cancer CenterLouisville, Kentucky  40202
University of Rochester Medical CenterRochester, New York  14642
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
University of VirginiaCharlottesville, Virginia  22908
University of UtahSalt Lake City, Utah  
Duke University Medical CenterDurham, North Carolina  27710
Bay Area Cancer Research GroupConcord, California  94520
Vermont Cancer Center at Fletcher Allen Health CareBurlington, Vermont  05401
Atlanta Institute for Medical ResearchDecatur, Georgia  30030
Harbor - UCLA Medical CenterTorrance, California  90509
University of CT Health CenterFarmington, Connecticut  06030
Georgetown University Hospital - Lombardi Cancer CtrWashington, District of Columbia  20007
Halifax HealthDaytona Beach, Florida  32114
Orchard Healthcare Research Inc.Skokie, Illinois  60076
Bringham and Women's HospitalBoston, Massachusetts  02115
Henry Ford Hospital K-15Detroit, Michigan  48202
Stony Brook University, Medical CenterStony Brook, New York  11794
MidDakota ClinicBismarck, North Dakota  58501