Trial Outcomes & Findings for Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer (NCT NCT01299038)
NCT ID: NCT01299038
Last Updated: 2020-02-05
Results Overview
Comparison of plasma microparticle concentration between baseline and week 4
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-02-05
Participant Flow
Participant milestones
| Measure |
Rosuvastatin 20
Rosuvastatin 20mg taken orally once a day for 4 weeks
|
Rosuvastatin 40
Rosuvastatin 40mg taken orally once a day for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Rosuvastatin 20
Rosuvastatin 20mg taken orally once a day for 4 weeks
|
Rosuvastatin 40
Rosuvastatin 40mg taken orally once a day for 4 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Rosuvastatin 20mg
n=9 Participants
Rosuvastatin 20mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks
|
Rosuvastatin 40mg
n=10 Participants
Rosuvastatin 40mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks
|
Total
n=19 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksComparison of plasma microparticle concentration between baseline and week 4
Outcome measures
| Measure |
Rosuvastatin 20mg
n=8 Participants
Rosuvastatin 20mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks
|
Rosuvastatin 40mg
n=7 Participants
Rosuvastatin 40mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks
|
|---|---|---|
|
Mean Change of Tissue Factor Bearing Microparticles
|
102 microparticles per microliter
Standard Deviation 586
|
-618 microparticles per microliter
Standard Deviation 624
|
Adverse Events
Rosuvastatin 20mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Rosuvastatin 40mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rosuvastatin 20mg
n=9 participants at risk
Rosuvastatin 20mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks
|
Rosuvastatin 40mg
n=10 participants at risk
Rosuvastatin 40mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks
|
|---|---|---|
|
General disorders
Pain
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
30.0%
3/10 • Assessed during the 4 weeks therapy
|
|
General disorders
Edema limbs
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
General disorders
Chills
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Assessed during the 4 weeks therapy
|
20.0%
2/10 • Assessed during the 4 weeks therapy
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
20.0%
2/10 • Assessed during the 4 weeks therapy
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
40.0%
4/10 • Assessed during the 4 weeks therapy
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Vascular disorders
Hot flashes
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
30.0%
3/10 • Assessed during the 4 weeks therapy
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Metabolism and nutrition disorders
Iron overload
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Nervous system disorders
Encephalopathy
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
General disorders
Fatigue
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • Assessed during the 4 weeks therapy
|
10.0%
1/10 • Assessed during the 4 weeks therapy
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks therapy
|
|
General disorders
Nightmares
|
11.1%
1/9 • Assessed during the 4 weeks therapy
|
0.00%
0/10 • Assessed during the 4 weeks 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