Trial Outcomes & Findings for Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer (NCT NCT02115984)
NCT ID: NCT02115984
Last Updated: 2014-07-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)
Results posted on
2014-07-15
Participant Flow
Participant milestones
| Measure |
Chemotherapy & Panagen
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
Chemotherapy & Placebo
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
23
|
|
Overall Study
COMPLETED
|
51
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Chemotherapy & Panagen
n=57 Participants
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
Chemotherapy & Placebo
n=23 Participants
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
52 years
STANDARD_DEVIATION 7 • n=5 Participants
|
53 years
STANDARD_DEVIATION 8 • n=7 Participants
|
52 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)Outcome measures
| Measure |
Chemotherapy & Panagen
n=51 Participants
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
Chemotherapy & Placebo
n=16 Participants
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
|---|---|---|
|
The Quantity of Leukocytes and Neutrophils in the Blood of Patients
Leukocytes baseline
|
8.1 10^9 cells/L
Interval 6.5 to 8.8
|
7.2 10^9 cells/L
Interval 6.5 to 7.9
|
|
The Quantity of Leukocytes and Neutrophils in the Blood of Patients
Leukocytes after the 2nd chemotherapy
|
6.6 10^9 cells/L
Interval 5.9 to 7.2
|
4.8 10^9 cells/L
Interval 4.1 to 5.6
|
|
The Quantity of Leukocytes and Neutrophils in the Blood of Patients
Leukocytes after the 3rd chemotherapy
|
5 10^9 cells/L
Interval 4.6 to 5.5
|
4.1 10^9 cells/L
Interval 3.8 to 4.4
|
|
The Quantity of Leukocytes and Neutrophils in the Blood of Patients
Neutrophils baseline
|
5.33 10^9 cells/L
Interval 4.42 to 6.36
|
5.2 10^9 cells/L
Interval 4.2 to 6.05
|
|
The Quantity of Leukocytes and Neutrophils in the Blood of Patients
Neutrophils after the 2nd chemotherapy
|
4.62 10^9 cells/L
Interval 3.43 to 4.82
|
2.76 10^9 cells/L
Interval 2.22 to 3.27
|
|
The Quantity of Leukocytes and Neutrophils in the Blood of Patients
Neutrophils after the 3rd chemotherapy
|
3.19 10^9 cells/L
Interval 1.81 to 3.58
|
2.44 10^9 cells/L
Interval 2.31 to 2.63
|
Adverse Events
Chemotherapy & Panagen
Serious events: 57 serious events
Other events: 1 other events
Deaths: 0 deaths
Chemotherapy & Placebo
Serious events: 23 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy & Panagen
n=33 participants at risk；n=57 participants at risk
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
Chemotherapy & Placebo
n=11 participants at risk；n=23 participants at risk
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
|---|---|---|
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Immune system disorders
Herpetic eruption
|
0.00%
0/33
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
27.3%
3/11
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
45.5%
15/33
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
81.8%
9/11
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
|
Eye disorders
Dry eyes
|
39.4%
13/33
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
18.2%
2/11
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
|
Gastrointestinal disorders
Heartburn
|
27.3%
9/33
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
18.2%
2/11
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
57/57
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
100.0%
23/23
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
|
Gastrointestinal disorders
Nausea after the CT (before day 7)
|
100.0%
57/57
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
100.0%
23/23
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
Other adverse events
| Measure |
Chemotherapy & Panagen
n=33 participants at risk；n=57 participants at risk
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
Chemotherapy & Placebo
n=11 participants at risk；n=23 participants at risk
Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
3.0%
1/33
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
0.00%
0/11
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
|
Skin and subcutaneous tissue disorders
Hive-like allergic reaction
|
3.0%
1/33
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
0.00%
0/11
Some Serious Adverse Events and Other (Not Including Serious) Adverse Events were estimated not for all patients, but only for 33 from Panagen group and 11 from Placebo group.
|
Additional Information
Dr. Sergey S. Bogachev
Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
Phone: +7-963-946-57-69
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place