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Study Summary
No. 2008-0628:.......Unspecified......Carmen Escalante......General Internal Medicine/Ambulatory Treatment & Emergency Care
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Study Summary Title
Study Summary
Number:		2008-0628
Study Title:Dalteparin Sodium Injection (FRAGMINŽ), Multi-center, Open Label, Single Arm, Long Term (52 weeks) Study for Understanding Safety and Efficacy in Subjects with Malignancies and Symptomatic Venous Thromboembolism
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Physician New Patient Referral
Name:Carmen EscalantePatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:General Internal Medicine/Ambulatory Treatment & Emergency CareReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4516
Contact us about clinical trials
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General Information
Disease Group:UnspecifiedSupported By:Eisai
Phase of Study:Phase IVReturn
Visit:		N/A
Treatment
Agents:		DalteparinHome Care:Study Medication
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to learn about the safety of giving
FRAGMINŽ (dalteparin) to cancer patients for up to 6 extra months than is
standard. Researchers want to learn how often major bleeding events may occur
in these patients.

This study will also look at how often there are major bleeding events in
cancer patients with severe kidney problems who are receiving dalteparin.
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Study Objectives / Outcomes
The primary objective of the study is to determine the rate of major bleeding events in cancer subjects receiving extended treatment with dalteparin (> 6 months and up to 12 months) for prevention of recurrent symptomatic venous thromboembolism (VTE). Major bleeding event rates will be evaluated in all enrolled subjects and according to baseline renal function.

A bleeding event is considered major if it: 1) is accompanied by a decrease in hemoglobin of > 2g/dl in connection with clinical symptoms in a 24 hour period 2) occurs at a critical site (intraocular, spinal/epidural, intercranial, retroperitoneal, or pericardial bleeding); 3) leads to a transfusion of two or more units of packed red cells; 4) leads to death.

Secondary objectives will be to determine (for all subjects and according to baseline renal function): 1) the rate of symptomatic recurrent VTEs (proximal DVT and or PE) during treatment; 2) time to symptomatic recurrent VTE; 3) the rate of minor bleeding events; 4) time to first major bleeding event; 5) time to first bleeding event (any bleeding event); and 6) the safety and tolerability of extended treatment with dalteparin.

Additional secondary objectives include an evaluation of the utility of measuring anti-Xa activity to manage dose adjustment in subjects who present with or develop severe renal impairment (CRCl < 30mL/min).
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Study Status Information
Study Activation / Registration Date:09/25/2009
IRB Review and Approval Date:09/25/2009
Study Type:Other
Recruitment Status:Closed
Projected Accrual:338
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Age range: subjects must be greater than or equal to 18 years of age.

2) Male and female subjects will be eligible for enrollment.

3) Females should be either of non-childbearing potential as a result of surgery, radiational therapy, menopause (have been in menopause for > or = to 1 year), or of childbearing potential and willing to adhere to an acceptable method of pregnancy prevention

4) Subjects must be newly diagnosed proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both.

5) 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.

6) Prior to enrollment, subjects must not have received therapeutic doses of heparin or LMWH for > 96 hours (or > 8 doses within 96 hours) or oral anticoagulant therapy for > 48 hours (or > 2 doses within 48 hours).

7) ECOG performance status of 0, 1 or 2.

8) Subjects must have a life expectancy of > 6 months.

9) Subjects must have a platelet count of > 75,000 mm3.

10) The subject must not be on any oral anticoagulant therapy for concomitant diseases with the exception of acetylsalicylic acid (ASA). No other systemic anticoagulants are allowed during the study with the exception of allowance of institution-specific I.V. line patency protocols.

11) Subjects must have no active or serious bleeding episodes within two weeks prior to study entry.

12) Subjects must be able to comply with scheduled follow-ups.

13) Subjects must give written informed consent.
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 DVTs.

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, or 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 aspirin ASA < or = to 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.
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Links
Registration Number: NCT00942968
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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