ThrombosisPhase 2NCT00320255
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
A Phase 2 study testing Apixaban in people with Thrombosis and Cancer, run by Bristol-Myers Squibb at 14 sites in 2 countries.
Trial summary
The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thrombosis, Cancer, Pulmonary Embolism
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jun 2006to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
- Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
- Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
- Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law
Who cannot join
- Women who are pregnant, breastfeeding
- History of deep vein thrombosis or pulmonary embolism
- Active bleeding or at high risk of bleeding
- Metastatic brain cancer
- Familial bleeding diathesis
- Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
Show all 11Show fewer
- Expected survival <6 months or an Eastern Cooperative Oncology Group performance status ≥3.
- Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
- Uncontrolled hypertension (systolic blood pressure >200 mm Hg and/or diastolic blood pressure >110 mm Hg
- Coagulopathy (international normalized ratio >1.5 or platelet count <100*10^9/L) if not yet receiving chemotherapy or <50*10^9/L if receiving chemotherapy). Platelet count must have been >100*10^9/L before starting study medication
- One or more of the following: alanine aminotransferase >3 times the upper limit of normal (ULN), total bilirubin >2*ULN, or calculated creatinine clearance <30 mL/min.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States8 sites
Dana-Farber Cancer Inst
Boston, Massachusetts, 02115
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, 77030
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Mount Sinai School Of Medicine
New York, New York, 10029
University Of Rochester
Rochester, New York, 14642
Arizona Cancer Center
Tucson, Arizona, 85724
Canada6 sites
Local Institution
Hamilton, Ontario, L8V 2C5
Local Institution
London, Ontario, N6A 4L6
Local Institution
Montreal, Quebec, H1T 2M4
Local Institution
Montreal, Quebec, H3G 1A4
Local Institution
Toronto, Ontario, M4N 3M5
Local Institution
Toronto, Ontario, M5G 2M9
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study
The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
- Conditions
- Thrombosis, Cancer, Pulmonary Embolism
- Being tested
- Apixaban, Placebo
- Keywords
- anticoagulant
- Medical subject headings
- Thrombosis, Neoplasms, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called BMS-562247
Oral tablets administered once daily in 5-, 10-, or 20-mg dose
PlaceboDrug
Oral tablets administered once daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Participants received placebo tablets once daily Receives: Drug: Placebo |
| Cohort 1: Apixaban, 5 mg | Placebo comparator | Participants received apixaban as tablet, 5 mg, once daily Receives: Drug: Apixaban |
| Cohort 1: Apixaban, 10 mg | Active comparator | Participants received apixaban as tablet, 10 mg, once daily Receives: Drug: Apixaban |
| Cohort 1: Apixaban, 20 mg | Active comparator | Participants received apixaban as tablet, 20 mg, once daily Receives: Drug: Apixaban |
| Cohort 2: Placebo | Placebo comparator | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. Receives: Drug: Placebo |
| Cohort 2: Apixaban, 5 mg | Active comparator | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:
- A decrease in hemoglobin of 20 g/L or more or
- Required transfusion of 2 or more units of packed red blood cells or whole blood, or
- Occurred in a critical site
- Contributed to death.
CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:
- Skin hematoma
- Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention
- Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract
- Any other bleeding type that was considered to have clinical consequences.
Measured: From first dose to 2 days following last dose of study drug
Secondary outcomes (11)
Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
- New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
- Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
- Constant intraluminal filling defects in 2 or more views on pulmonary angiography
- Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
- A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
- An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
- Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Measured: First dose to 2 days following last dose of study drug
Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
Any 1 of the following was considered diagnostic for DVT:
- New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS
- Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
- Constant intraluminal filling defects in 2 or more views on pulmonary angiography
- Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
- A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
- An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2
- Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Measured: First dose to 30 days following last dose of study drug
Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
- New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
- Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
- Constant intraluminal filling defects in 2 or more views on pulmonary angiography
- Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
- A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
- An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
- Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Measured: First dose to 2 days following last dose of study drug
Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death
VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:
- New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
- Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
- Constant intraluminal filling defects in 2 or more views on pulmonary angiography
- Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
- A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
- An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
- Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Measured: First dose to 2 days following last dose of study drug
Number of Participants With All-Cause Death
Measured: First dose to 2 days following last dose of study drug
Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
Any 1 of the following was considered diagnostic for PE:
- Constant intraluminal filling defects in 2 or more views on pulmonary angiography
- Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram
- A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
- An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
- Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Measured: First dose to 2 days following last dose of study drug
Number of Participants With Nonfatal Pulmonary Embolism
Any 1 of the following was considered diagnostic for PE:
- Constant intraluminal filling defects in 2 or more views on pulmonary angiography
- Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
- A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
- An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
- Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Measured: First dose to 2 days following last dose of study drug
Number of Participants With Deep Vein Thrombosis
Any 1 of the following was considered diagnostic for DVT:
- New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
- Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Measured: First dose to 2 days following last dose of study drug
Number of Participants With Distal Deep Vein Thrombosis
Any 1 of the following was considered diagnostic for DVT:
- New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
- Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Measured: First dose to 2 days following last dose of study drug
Number of Participants With Proximal Deep Vein Thrombosis
Any 1 of the following was considered diagnostic for DVT:
- New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
- Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Measured: First dose to 2 days following last dose of study drug
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Measured: First dose to 2 days following last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ontario Clinical Oncology Group (OCOG)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320255
- Sponsor's protocol ID
- CV185-027
- Status last verified
- Aug 2016
- First submitted
- 28 Apr 2006
- Last updated
- 16 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.
PubMed 34622445Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
PubMed 33337539
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study
- ClinicalTrials.gov ID
- NCT00320255
- Acronym / sponsor ID
- CV185-027
- Conditions
- Thrombosis, Cancer, Pulmonary Embolism
- Keywords
- anticoagulant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ontario Clinical Oncology Group (OCOG)
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Posted 16 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo tablets once daily |
| Cohort 1: Apixaban, 5 mg | Placebo comparator | Drug: ApixabanParticipants received apixaban as tablet, 5 mg, once daily |
| Cohort 1: Apixaban, 10 mg | Active comparator | Drug: ApixabanParticipants received apixaban as tablet, 10 mg, once daily |
| Cohort 1: Apixaban, 20 mg | Active comparator | Drug: ApixabanParticipants received apixaban as tablet, 20 mg, once daily |
| Cohort 2: Placebo | Placebo comparator | Drug: PlaceboParticipants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| Cohort 2: Apixaban, 5 mg | Active comparator | Drug: ApixabanParticipants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
- Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
- Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
- Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law
Key exclusion criteria (11 listed)
- Women who are pregnant, breastfeeding
- History of deep vein thrombosis or pulmonary embolism
- Active bleeding or at high risk of bleeding
- Metastatic brain cancer
- Familial bleeding diathesis
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 |
|---|---|---|
| ApixabanAlso: BMS-562247Oral tablets administered once daily in 5-, 10-, or 20-mg dose | Drug | Cohort 1: Apixaban, 10 mg, Cohort 1: Apixaban, 20 mg, Cohort 1: Apixaban, 5 mg, Cohort 2: Apixaban, 5 mg |
| PlaceboOral tablets administered once daily | Drug | Cohort 1: Placebo, Cohort 2: Placebo |
Primary outcome
Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
Time frame: From first dose to 2 days following last dose of study drug
Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following: * A decrease in hemoglobin of 20 g/L or more or * Required transfusion of 2 or more units of packed red blood cells or whole blood, or * Occurred in a critical site * Contributed to death. CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including: * Skin hematoma * Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention * Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract * Any other bleeding type that was considered to have clinical consequences.
11 secondary outcomes
Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
Time frame: First dose to 30 days following last dose of study drug
Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With All-Cause Death
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With Nonfatal Pulmonary Embolism
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With Deep Vein Thrombosis
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With Distal Deep Vein Thrombosis
Time frame: First dose to 2 days following last dose of study drug
Number of Participants With Proximal Deep Vein Thrombosis
Time frame: First dose to 2 days following last dose of study drug
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
Time frame: First dose to 2 days following last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34622445Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.
- Derived from this study: PubMed 33337539Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apixaban in people with Thrombosis and Cancer, run by Bristol-Myers Squibb at 14 sites in 2 countries.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding (time frame: From first dose to 2 days following last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00320255, which also lists 2 linked publications.
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 16 Aug 2016.