Trial Outcomes & Findings for Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia (NCT NCT04629443)
NCT ID: NCT04629443
Last Updated: 2024-06-06
Results Overview
Incidence of DLTs starting from the Lead-In Dose period to the end of the first cycle of treatment of S64315 in combination with azacitidine.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Day -13 to Cycle 1 Day 28 (each cycle is 28 days)
Results posted on
2024-06-06
Participant Flow
Participant milestones
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
5
|
Reasons for withdrawal
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Progressive Disease
|
2
|
3
|
3
|
|
Overall Study
Physician Decision
|
1
|
3
|
0
|
Baseline Characteristics
Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia
Baseline characteristics by cohort
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Age, Customized
18 to less then 65
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
65 to less then 85
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day -13 to Cycle 1 Day 28 (each cycle is 28 days)Incidence of DLTs starting from the Lead-In Dose period to the end of the first cycle of treatment of S64315 in combination with azacitidine.
Outcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=3 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=6 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=4 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Dose Limiting Toxicity (DLT) (Phase I - Dose Escalation)
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: an average of 6 monthsIncidence and severity of AEs according to NCI CTCAE v5.0
Outcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Number of Adverse Events (AEs) and Severe AEs (Phase I - Dose Escalation)
Total Number of AEs
|
72 Events
|
56 Events
|
41 Events
|
|
Number of Adverse Events (AEs) and Severe AEs (Phase I - Dose Escalation)
Number of Severe AEs
|
39 Events
|
22 Events
|
13 Events
|
PRIMARY outcome
Timeframe: Day -13 up to 30 calendar days after the patient's last study visit (an average of 6 months)Incidence and severity of SAEs according to NCI CTCAE v5.0
Outcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Number of Serious Adverse Event (SAEs) and Fatal SAEs (Phase I - Dose Escalation)
Total Number of SAEs
|
16 Events
|
14 Events
|
5 Events
|
|
Number of Serious Adverse Event (SAEs) and Fatal SAEs (Phase I - Dose Escalation)
Fatal SAEs
|
2 Events
|
2 Events
|
0 Events
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 monthsOutcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Number of Participants With Dose Interruptions (Phase I - Dose Escalation)
Dose delay
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Dose Interruptions (Phase I - Dose Escalation)
Dose interruption
|
4 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 monthsOutcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Number of Participants With Dose Reductions (Phase I - Dose Escalation)
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 monthsOutcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Dose Intensity for S64315 (Phase I - Dose Escalation)
|
41.0 mg/week
Standard Deviation 2.7
|
60.3 mg/week
Standard Deviation 19.8
|
119.6 mg/week
Standard Deviation 19.9
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 monthsPopulation: One participant in the 100 mg arm did not receive azacitidine and therefore was not eligible for analysis.
Outcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=6 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Dose Intensity for Azacitidine (Phase I - Dose Escalation)
|
23.5 mg/m^2/week
Standard Deviation 17.0
|
18.8 mg/m^2/week
Standard Deviation 0.3
|
22.9 mg/m^2/week
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Through study completion, an average of 6 monthsPopulation: In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected.
Overall survival (OS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 6 monthsPopulation: In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected.
Duration of response (DOR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 6 monthsPopulation: In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected.
Best overall response (BOR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 6 monthsPopulation: In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected.
Progression-free survival (PFS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 6 monthsPopulation: In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected.
Disease-free survival (DFS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Cycle 1 Day 2 and Cycle 1 Day 9 (each cycle is 28 days)Population: For Cycle 1 Day 9 in the 50 mg S64315 arm, the blood sample was collected from the same site of IV infusion and therefore, no descriptive statistics were derived due to unreliable PK Data. The other cohorts had less patients analyzed due to missing patient data.
Outcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=3 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=4 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=3 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Area Under the Curve (AUC) (Phase I - Dose Escalation)
Cycle 1 Day 2
|
1588 ng.h/mL
Geometric Coefficient of Variation 2.9
|
1929 ng.h/mL
Geometric Coefficient of Variation 71
|
7393 ng.h/mL
Geometric Coefficient of Variation 38
|
|
Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Area Under the Curve (AUC) (Phase I - Dose Escalation)
Cycle 1 Day 9
|
—
|
2235 ng.h/mL
Geometric Coefficient of Variation NA
It is not applicable since there was only 1 participant analyzed.
|
8584 ng.h/mL
Geometric Coefficient of Variation NA
It is not applicable since there was only 1 participant analyzed.
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 2 and Cycle 1 Day 9 (each cycle is 28 days)Population: For Cycle 1 Day 9 in the 50 mg S64315 arm, the blood sample was collected from the same site of IV infusion and therefore, no descriptive statistics were derived due to unreliable PK Data. The other cohorts had less patients analyzed due to missing patient data.
Outcome measures
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=3 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=4 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=3 Participants
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Maximum Concentration (Cmax) (Phase I - Dose Escalation)
Cycle 1 Day 2
|
923 ng/mL
Geometric Coefficient of Variation 16
|
1021 ng/mL
Geometric Coefficient of Variation 59
|
3646 ng/mL
Geometric Coefficient of Variation 36
|
|
Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Maximum Concentration (Cmax) (Phase I - Dose Escalation)
Cycle 1 Day 9
|
—
|
1850 ng/mL
Geometric Coefficient of Variation NA
It is not applicable since there was only 1 participant analyzed.
|
4520 ng/mL
Geometric Coefficient of Variation NA
It is not applicable since there was only 1 participant analyzed.
|
Adverse Events
50 mg S64315 (Also Referred as MIK665) With Azacitidine
Serious events: 5 serious events
Other events: 5 other events
Deaths: 2 deaths
100 mg S64315 (Also Referred as MIK665) With Azacitidine
Serious events: 7 serious events
Other events: 6 other events
Deaths: 5 deaths
190 mg S64315 (Also Referred as MIK665) With Azacitidine
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 participants at risk
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 participants at risk
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 participants at risk
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Anorectal cellulitis
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Bacteraemia
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Device related infection
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Escherichia bacteraemia
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Sinusitis aspergillus
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
80.0%
4/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
28.6%
2/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Troponin I increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Psychiatric disorders
Aggression
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
Other adverse events
| Measure |
50 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 participants at risk
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
100 mg S64315 (Also Referred as MIK665) With Azacitidine
n=7 participants at risk
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
190 mg S64315 (Also Referred as MIK665) With Azacitidine
n=5 participants at risk
S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
80.0%
4/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
28.6%
2/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
60.0%
3/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
28.6%
2/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Troponin T increased
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
28.6%
2/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Blood creatinine increased
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Constipation
|
80.0%
4/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
28.6%
2/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Gingival bleeding
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
General disorders
Oedema peripheral
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
General disorders
Administration site erythema
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
General disorders
Impaired healing
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
General disorders
Injection site haematoma
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
General disorders
Injection site rash
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
2/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Folliculitis
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Herpes simplex reactivation
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
14.3%
1/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
0.00%
0/7 • Up to 30 days after the patients last study visit (an average of 6 months)
|
20.0%
1/5 • Up to 30 days after the patients last study visit (an average of 6 months)
|
Additional Information
Clinical Studies Department
Institut de Recherches Internationales Servier (I.R.I.S.)
Phone: +33 1 55 72 60 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER