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

NCT00942968

Last updated date
Study Location
Arizona Cancer Center
Tuscon, Arizona, 85719, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the long term tolerability and safety of dalteparin in subjects with cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE Drug: dalteparin
Daily subcutaneous injection 200IU/kg dalteparin
Study Arms  ICMJE Experimental: 1
Intervention: Drug: dalteparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2009)
338
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Netherlands,   Spain,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT00942968
Other Study ID Numbers  ICMJE FRAG-A001-401
A6301095 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Study Director:Gary Palmer, MDMedical Affairs, Eisai, Inc
PRS Account Pfizer
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP