Venous ThromboembolismPhase 2NCT00981903
Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
A Phase 2 study testing Tinzaparin sodium in people with Venous Thromboembolism and Cancer, run by University of Southern California at 2 sites in United States.
Trial summary
In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Cancer
- What is being tested?
- Tinzaparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of active cancer
- Patients have documented or recurrent malignancy and must meet at least one of the following criteria:
- Diagnosis or documented presence of cancer within 6 months, excluding squamous cell or basal cell carcinoma of the skin OR
- Receive any therapy for cancer within the previous 6 months OR
- Currently receiving any treatment (surgery, radiation, chemotherapy, hormonal therapy, biotherapy, palliative therapy, and/or combined modality therapy) for cancer
- Documented first venous thromboembolic event
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- Patients must meet at least one of the following criteria:
- Deep vein thrombosis of the lower extremity confirmed with duplex ultrasonography, magnetic resonance imaging, or venogram OR
- Pulmonary embolism confirmed with high probability V/Q scan, CT angiogram, or pulmonary angiogram
- ECOG performance status of 0, 1, or 2
- Signed written informed consent
- Age 18 years or greater
Who cannot join
- Body weight less than 40 kg
- Recurrent spontaneous fractures unrelated to the underlying active malignancy
- Administration of therapeutic doses of unfractionated or low molecular weight heparin for more than 48 hours prior to registration Amendment 3 (05/26/2009) 11
- Need for long-term oral anticoagulant therapy (e.g., mechanical heart valves, atrial fibrillation)
- Poor performance status with an ECOG score of 3 or 4
- Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 2 weeks of presentation
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- Known acute (symptomatic or active bleeding) gastroduodenal ulcer
- Epidural/spinal puncture within the last 24 hours
- Neurosurgery within 1 week of registration or any previous history of intracranial hemorrhage
- Septic endocarditis
- Overt pericardial effusion
- Current platelet count of less than 50 x 109/L
- Undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia, or has other conditions associated with persistent thrombocytopenia of less than 100 109/L for a duration of at least four consecutive weeks
- Familial bleeding diathesis
- Uncontrolled hypertension despite antihypertensive therapy
- Dependent upon renal dialysis or significant renal failure with a serum creatinine of greater than three times the upper limit of normal
- Allergy to heparin (unfractionated or low molecular weight)
- Allergy to contrast medium
- Pregnant or of childbearing potential and not using adequate contraception
- Geographically inaccessible for follow-up
- Failure or inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Southern California
Los Angeles, California, 90033
Cornell Weill Scholl of Medicine
New York, New York, 10021
About this study
In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment.
Read the detailed description
The purpose of this study is to use long-term administration of a low molecular weight heparin (tinzaparin) for primary treatment and secondary prophylaxis of venous thromboembolism in patients with cancer. We will determine the efficacy (recurrent VTE) and safety (major hemorrhage) of this approach. Secondarily, we will analyze the outcome of patients in terms of survival and response to therapy versus matched controls. We will also determine baseline levels of markers of hemostasis, fibrinolysis, and angiogenesis and will follow changes with treatment as well as correlate levels of these plasma markers with outcomes, including recurrent venous thromboembolism, major hemorrhage,and survival.
- Conditions
- Venous Thromboembolism, Cancer
- Being tested
- Tinzaparin sodium
- Keywords
- VTE in cancer patients
- Medical subject headings
- Venous Thromboembolism, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinzaparin sodiumDrug
Subcutaneous injection 175 U/Kg/day
| Study group | Role | What they receive |
|---|---|---|
| VTE Treatment Group | Experimental | Not described Receives: Drug: Tinzaparin sodium |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of recurrent venous thromboembolism and major hemorrhage.
Measured: up to 6 months on treatment
Secondary outcomes (1)
Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startJul 2005
- Primary completionOct 2012
- Study completionOct 2015
Why it stopped: Tinzaparin will no longer be available in the United States
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981903
- Sponsor's protocol ID
- 0S-04-5
- Status last verified
- Jul 2017
- First submitted
- 18 Sep 2009
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
- ClinicalTrials.gov ID
- NCT00981903
- Acronym / sponsor ID
- 0S-04-5
- Conditions
- Venous Thromboembolism, Cancer
- Keywords
- VTE in cancer patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Tinzaparin will no longer be available in the United States
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jul 2005
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment.
Detailed description
The purpose of this study is to use long-term administration of a low molecular weight heparin (tinzaparin) for primary treatment and secondary prophylaxis of venous thromboembolism in patients with cancer. We will determine the efficacy (recurrent VTE) and safety (major hemorrhage) of this approach. Secondarily, we will analyze the outcome of patients in terms of survival and response to therapy versus matched controls. We will also determine baseline levels of markers of hemostasis, fibrinolysis, and angiogenesis and will follow changes with treatment as well as correlate levels of these plasma markers with outcomes, including recurrent venous thromboembolism, major hemorrhage,and survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VTE Treatment Group | Experimental | Drug: Tinzaparin sodium |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of active cancer
- Patients have documented or recurrent malignancy and must meet at least one of the following criteria:
- Documented first venous thromboembolic event
- Patients must meet at least one of the following criteria:
- ECOG performance status of 0, 1, or 2
Key exclusion criteria (21 listed)
- Body weight less than 40 kg
- Recurrent spontaneous fractures unrelated to the underlying active malignancy
- Administration of therapeutic doses of unfractionated or low molecular weight heparin for more than 48 hours prior to registration Amendment 3 (05/26/2009) 11
- Need for long-term oral anticoagulant therapy (e.g., mechanical heart valves, atrial fibrillation)
- Poor performance status with an ECOG score of 3 or 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinzaparin sodiumSubcutaneous injection 175 U/Kg/day | Drug | VTE Treatment Group |
Primary outcome
Development of recurrent venous thromboembolism and major hemorrhage.
Time frame: up to 6 months on treatment
1 secondary outcome
Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Tinzaparin will no longer be available in the United States). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tinzaparin sodium in people with Venous Thromboembolism and Cancer, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Tinzaparin will no longer be available in the United States). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of recurrent venous thromboembolism and major hemorrhage. (time frame: up to 6 months on treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.