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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Arizona Cancer Center
Tuscon, Arizona, 85719 United States
Contact
1-800-718-1021
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.

NCT00942968
Pfizer
Completed
Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer

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Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer
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
The purpose of this study is to determine the long term tolerability and safety of dalteparin in subjects with cancer.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
Drug: dalteparin
Daily subcutaneous injection 200IU/kg dalteparin
Experimental: 1
Intervention: Drug: dalteparin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
338
June 2013
March 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   Netherlands,   Spain,   United States
Australia
 
NCT00942968
FRAG-A001-401
A6301095 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Gary Palmer, MD Medical Affairs, Eisai, Inc
Pfizer
January 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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