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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Eisai Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00942968
First received: July 16, 2009
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Cancer
Drug: dalteparin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Physical examinations, lab evaluations, creatine clearance, electrocardiograms, adverse events, imaging (computed tomography, magnetic resonance imaging, ultrasound). [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 338
Study Start Date: June 2009
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalteparin
Daily subcutaneous injection 200IU/kg dalteparin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942968

  Show 42 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Gary Palmer, MD Medical Affairs, Eisai, Inc
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00942968     History of Changes
Other Study ID Numbers: FRAG-A001-401
Study First Received: July 16, 2009
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Venous Thromboembolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014