Trial Outcomes & Findings for Cancer Associated Thrombosis and Isoquercetin (CATIQ) (NCT NCT02195232)
NCT ID: NCT02195232
Last Updated: 2021-03-03
Results Overview
D-dimer concentrations will be compared for each patient at day 0 and day 56 by a paired-t test analysis. Analysis will be performed on an intention to treat basis for patients who undergo randomization and completed the baseline and day 56 D-dimer assessments.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
64 participants
Primary outcome timeframe
Baseline, 56 Day
Results posted on
2021-03-03
Participant Flow
Participant milestones
| Measure |
Cohort A (Isoquercetin 500 mg)
Patients will receive isoquercetin 500 mg once daily (2 capsules).
|
Cohort B (Isoquercetin 1000 mg)
Patients will receive isoquercetin 1000 mg once daily (4 capsules).
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluated for VTE and safety
Baseline characteristics by cohort
| Measure |
Cohort A (Isoquercetin 500 mg)
n=32 Participants
Patients will receive isoquercetin 500 mg once daily (2 capsules).
|
Cohort B (Isoquercetin 1000 mg)
n=32 Participants
Patients will receive isoquercetin 1000 mg once daily (4 capsules).
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants • Evaluated for VTE and safety
|
0 Participants
n=29 Participants • Evaluated for VTE and safety
|
0 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=28 Participants • Evaluated for VTE and safety
|
17 Participants
n=29 Participants • Evaluated for VTE and safety
|
32 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Age, Categorical
>=65 years
|
13 Participants
n=28 Participants • Evaluated for VTE and safety
|
12 Participants
n=29 Participants • Evaluated for VTE and safety
|
25 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Sex: Female, Male
Female
|
14 Participants
n=28 Participants • Evaluated for VTE and safety
|
9 Participants
n=29 Participants • Evaluated for VTE and safety
|
23 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Sex: Female, Male
Male
|
14 Participants
n=28 Participants • Evaluated for VTE and safety
|
20 Participants
n=29 Participants • Evaluated for VTE and safety
|
34 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants • Evaluated for VTE and safety
|
0 Participants
n=29 Participants • Evaluated for VTE and safety
|
0 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=28 Participants • Evaluated for VTE and safety
|
2 Participants
n=29 Participants • Evaluated for VTE and safety
|
2 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants • Evaluated for VTE and safety
|
0 Participants
n=29 Participants • Evaluated for VTE and safety
|
0 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=28 Participants • Evaluated for VTE and safety
|
5 Participants
n=29 Participants • Evaluated for VTE and safety
|
9 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
White
|
23 Participants
n=28 Participants • Evaluated for VTE and safety
|
19 Participants
n=29 Participants • Evaluated for VTE and safety
|
42 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=28 Participants • Evaluated for VTE and safety
|
0 Participants
n=29 Participants • Evaluated for VTE and safety
|
0 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=28 Participants • Evaluated for VTE and safety
|
3 Participants
n=29 Participants • Evaluated for VTE and safety
|
4 Participants
n=57 Participants • Evaluated for VTE and safety
|
|
Region of Enrollment
United States
|
28 Participants
n=28 Participants • Evaluated for VTE and safety
|
29 Participants
n=29 Participants • Evaluated for VTE and safety
|
57 Participants
n=57 Participants • Evaluated for VTE and safety
|
PRIMARY outcome
Timeframe: Baseline, 56 DayPopulation: The analysis data set is comprised of evaluable patients.
D-dimer concentrations will be compared for each patient at day 0 and day 56 by a paired-t test analysis. Analysis will be performed on an intention to treat basis for patients who undergo randomization and completed the baseline and day 56 D-dimer assessments.
Outcome measures
| Measure |
Cohort A (Isoquercetin 500 mg)
n=28 Participants
Patients will receive isoquercetin 500 mg once daily (2 capsules).
|
Cohort B (Isoquercetin 1000 mg)
n=29 Participants
Patients will receive isoquercetin 1000 mg once daily (4 capsules).
|
|---|---|---|
|
Percent Change in D-dimer Value
|
9.9 percent change
Interval -51.1 to 74.2
|
-21.9 percent change
Interval -63.3 to 36.5
|
SECONDARY outcome
Timeframe: study visits until day 56Investigating the safety of isoquercetin in cancer patients
Outcome measures
| Measure |
Cohort A (Isoquercetin 500 mg)
n=28 Participants
Patients will receive isoquercetin 500 mg once daily (2 capsules).
|
Cohort B (Isoquercetin 1000 mg)
n=29 Participants
Patients will receive isoquercetin 1000 mg once daily (4 capsules).
|
|---|---|---|
|
Number of Participants With Hemorrhage
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 56 daysPopulation: All patients who began assigned treatment were analyzed.
To investigate the cumulative incidence of VTE according to tissue factor bearing microparticle status (and isoquercetin randomization).
Outcome measures
| Measure |
Cohort A (Isoquercetin 500 mg)
n=28 Participants
Patients will receive isoquercetin 500 mg once daily (2 capsules).
|
Cohort B (Isoquercetin 1000 mg)
n=29 Participants
Patients will receive isoquercetin 1000 mg once daily (4 capsules).
|
|---|---|---|
|
Cumulative Incidence of VTE at 56 Days
|
0 participants
|
0 participants
|
Adverse Events
Cohort A (Isoquercetin 500 mg)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort B (Isoquercetin 1000 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A (Isoquercetin 500 mg)
n=28 participants at risk
Cohort A: Patients will receive isoquercetin 500 mg once daily (2 capsules) for 28 days.
Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days.
|
Cohort B (Isoquercetin 1000 mg)
n=29 participants at risk
Cohort B: Patients will receive isoquercetin 1000 mg once daily (4 capsules) for 28 days.
Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Number of events 1 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/29 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
4/28 • Number of events 4 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/29 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
1/28 • Number of events 1 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/29 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.00%
0/28 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
3.4%
1/29 • Number of events 1 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Number of events 1 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/29 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Number of events 2 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/29 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/29 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.6%
1/28 • Number of events 1 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/29 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/28 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
6.9%
2/29 • Number of events 2 • All adverse events data were collected form the time of the first dose (Day 1) of study treatment, through the study and until the final study visit (Day 56).
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
Additional Information
Jeffrey Zwicker, Division of Thrombosis and Haemostasis, Division of Hematology and Oncology
Beth Israel Deaconess Medical Center, Harvard Medical School
Phone: 617.667.9299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place