Trial Outcomes & Findings for Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles (NCT NCT00908960)
NCT ID: NCT00908960
Last Updated: 2017-12-19
Results Overview
2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Assessment with lower extremity ultrasound occured at day 60/ month 2
Results posted on
2017-12-19
Participant Flow
Participant milestones
| Measure |
High TFMP: Enoxaparin
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
High TFMP: Observation
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
Low TFMP: Observation
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
34
|
|
Overall Study
Evaluable
|
23
|
11
|
32
|
|
Overall Study
COMPLETED
|
23
|
11
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
High TFMP: Enoxaparin
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
High TFMP: Observation
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
Low TFMP: Observation
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
|
|---|---|---|---|
|
Overall Study
Presence VTE dx or Absent VTE eval
|
1
|
1
|
2
|
Baseline Characteristics
Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Baseline characteristics by cohort
| Measure |
High TFMP: Enoxaparin
n=23 Participants
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).
Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
High TFMP: Observation
n=11 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
Low TFMP: Observation
n=32 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessment with lower extremity ultrasound occured at day 60/ month 2Population: The analysis dataset is comprised of all evaluable patients.
2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.
Outcome measures
| Measure |
High TFMP: Enoxaparin
n=23 Participants
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
High TFMP: Observation
n=11 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
Low TFMP: Observation
n=32 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
|
|---|---|---|---|
|
2-Month Cumulative Incidence of VTE
|
5.6 percent probability
Interval 0.0 to 16.6
|
27.2 percent probability
Interval 0.0 to 55.1
|
7.2 percent probability
Interval 0.0 to 17.1
|
SECONDARY outcome
Timeframe: Assessed during the 60 day therapyPopulation: The analysis dataset is comprised of evaluable patients.
Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines. (Schulman and Kearon 2005)
Outcome measures
| Measure |
High TFMP: Enoxaparin
n=23 Participants
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
High TFMP: Observation
n=11 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
Low TFMP: Observation
n=32 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
|
|---|---|---|---|
|
Incidence of Major Hemorrhage Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed up to approximately 30 monthsPopulation: The analysis dataset is comprised of all evaluable patients.
Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
Outcome measures
| Measure |
High TFMP: Enoxaparin
n=23 Participants
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
High TFMP: Observation
n=11 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
Low TFMP: Observation
n=32 Participants
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
|
|---|---|---|---|
|
Overall Survival
|
17.8 months
Interval 5.2 to 30.0
|
11.8 months
Interval 5.4 to 18.2
|
17.3 months
Interval 10.3 to 24.3
|
Adverse Events
High TFMP: Enoxaparin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
High TFMP: Observation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Low TFMP: Observation
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High TFMP: Enoxaparin
n=23 participants at risk
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).
Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
High TFMP: Observation
n=11 participants at risk
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
|
Low TFMP: Observation
n=32 participants at risk
Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/23 • Assessed during the 60 day therapy
|
9.1%
1/11 • Number of events 1 • Assessed during the 60 day therapy
|
3.1%
1/32 • Number of events 1 • Assessed during the 60 day therapy
|
|
Investigations
Disease progression
|
8.7%
2/23 • Number of events 2 • Assessed during the 60 day therapy
|
9.1%
1/11 • Number of events 1 • Assessed during the 60 day therapy
|
9.4%
3/32 • Number of events 3 • Assessed during the 60 day therapy
|
|
Infections and infestations
Infection
|
0.00%
0/23 • Assessed during the 60 day therapy
|
0.00%
0/11 • Assessed during the 60 day therapy
|
3.1%
1/32 • Number of events 1 • Assessed during the 60 day therapy
|
|
Blood and lymphatic system disorders
Platelets
|
4.3%
1/23 • Number of events 1 • Assessed during the 60 day therapy
|
0.00%
0/11 • Assessed during the 60 day therapy
|
3.1%
1/32 • Number of events 1 • Assessed during the 60 day therapy
|
|
Metabolism and nutrition disorders
Alkaline Phosphotase and aspartate aminotransferase
|
4.3%
1/23 • Number of events 1 • Assessed during the 60 day therapy
|
0.00%
0/11 • Assessed during the 60 day therapy
|
0.00%
0/32 • Assessed during the 60 day therapy
|
|
Musculoskeletal and connective tissue disorders
Lymphatics
|
4.3%
1/23 • Number of events 1 • Assessed during the 60 day therapy
|
0.00%
0/11 • Assessed during the 60 day therapy
|
0.00%
0/32 • Assessed during the 60 day therapy
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia and anemia
|
4.3%
1/23 • Number of events 1 • Assessed during the 60 day therapy
|
0.00%
0/11 • Assessed during the 60 day therapy
|
0.00%
0/32 • Assessed during the 60 day therapy
|
|
Cardiac disorders
elevated troponin
|
0.00%
0/23 • Assessed during the 60 day therapy
|
9.1%
1/11 • Number of events 1 • Assessed during the 60 day therapy
|
0.00%
0/32 • Assessed during the 60 day therapy
|
|
Gastrointestinal disorders
GI-Hemorrhage
|
0.00%
0/23 • Assessed during the 60 day therapy
|
0.00%
0/11 • Assessed during the 60 day therapy
|
3.1%
1/32 • Number of events 1 • Assessed during the 60 day therapy
|
Additional Information
Jeffrey Zwicker, MD
Beth Israel Deaconess Medical Center
Phone: 617-667-9299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place