Trial Outcomes & Findings for Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors (NCT NCT05382936)
NCT ID: NCT05382936
Last Updated: 2025-01-09
Results Overview
* Safety endpoints include identification of DLTs; rate of TEAEs and SAEs; identification of abnormalities in physical examination, vital signs, clinical laboratory evaluations, and ECG findings. * PK endpoints include assessment of SL-901 plasma concentration over time; assessment of any changes in the PK properties of SL-901 between initial administration and steady-state and between cycles of treatment; explore the correlation between PK parameters and toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Approximately 2 years
Results posted on
2025-01-09
Participant Flow
Participant milestones
| Measure |
Cohort 1: SL-901 20 mg
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
4
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
4
|
6
|
Reasons for withdrawal
| Measure |
Cohort 1: SL-901 20 mg
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
5
|
2
|
5
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Deteriorated Performance Status. Unlikely Benefit
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1: SL-901 20 mg
n=3 Participants
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
n=7 Participants
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
n=4 Participants
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
n=6 Participants
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 6.58 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 14.35 • n=4 Participants
|
54.8 years
STANDARD_DEVIATION 0.05 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 yearsPopulation: Safety Population
* Safety endpoints include identification of DLTs; rate of TEAEs and SAEs; identification of abnormalities in physical examination, vital signs, clinical laboratory evaluations, and ECG findings. * PK endpoints include assessment of SL-901 plasma concentration over time; assessment of any changes in the PK properties of SL-901 between initial administration and steady-state and between cycles of treatment; explore the correlation between PK parameters and toxicity.
Outcome measures
| Measure |
Cohort 1: SL-901 20 mg
n=3 Participants
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
n=7 Participants
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
n=4 Participants
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
n=6 Participants
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
|---|---|---|---|---|
|
To Identify the MTD, Appropriate Dosing Regimen, PK Profile, and Perform Initial Assessment of the Safety Profile of SL-901
Any TEAE
|
3 adverse event
|
7 adverse event
|
4 adverse event
|
5 adverse event
|
|
To Identify the MTD, Appropriate Dosing Regimen, PK Profile, and Perform Initial Assessment of the Safety Profile of SL-901
Any SAE
|
1 adverse event
|
3 adverse event
|
6 adverse event
|
0 adverse event
|
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Safety Population
Clinical activity endpoints include the rate of objective response, rate of CR, DOR, PFS, and OS.
Outcome measures
| Measure |
Cohort 1: SL-901 20 mg
n=3 Participants
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
n=7 Participants
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
n=4 Participants
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
n=6 Participants
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
|---|---|---|---|---|
|
Assess Preliminary Clinical Activity of SL-901 - Best Overall Response
Best Overall Response - Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - Best Overall Response
Best Overall Response - Stable Disease
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - Best Overall Response
Best Overall Response - Progressive Disease
|
3 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - Best Overall Response
Best Overall Response - Not Evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Safety Population
Progression-free Survival - Investigator's Assessment
Outcome measures
| Measure |
Cohort 1: SL-901 20 mg
n=3 Participants
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
n=7 Participants
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
n=4 Participants
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
n=6 Participants
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
|---|---|---|---|---|
|
Assess Preliminary Clinical Activity of SL-901 - PFS
Subjects with event
|
3 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - PFS
Progressive Disease
|
3 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - PFS
Death
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - PFS
Censored subjects
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - PFS
No progressive disease and no death
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Assess Preliminary Clinical Activity of SL-901 - PFS
No post-baseline and no death
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort 1: SL-901 20 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: SL-901 40 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Cohort 3: SL-901 60 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Cohort 4: SL-901 80 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1: SL-901 20 mg
n=3 participants at risk
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
n=7 participants at risk
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
n=4 participants at risk
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
n=6 participants at risk
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
14.3%
1/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
14.3%
1/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
14.3%
1/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
Other adverse events
| Measure |
Cohort 1: SL-901 20 mg
n=3 participants at risk
Subjects received SL-901 20 mg for a 28-day treatment cycle at once daily dosing.
|
Cohort 2: SL-901 40 mg
n=7 participants at risk
Subjects received SL-901 40 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
Cohort 3: SL-901 60 mg
n=4 participants at risk
Subjects received SL-901 60 mg for a 28-day treatment cycle at once-daily dosing.
|
Cohort 4: SL-901 80 mg
n=6 participants at risk
Subjects received SL-901 80 mg for a 28-day treatment cycle at both once-daily and twice-daily dosing.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
50.0%
2/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
33.3%
2/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
16.7%
1/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
16.7%
1/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Eye disorders
Lacrimation increased
|
33.3%
1/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
14.3%
1/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
28.6%
2/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
14.3%
1/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
50.0%
2/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
28.6%
2/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
25.0%
1/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
16.7%
1/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
28.6%
2/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
50.0%
2/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
33.3%
2/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
14.3%
1/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
57.1%
4/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
100.0%
4/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
50.0%
3/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/7 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
0.00%
0/4 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
16.7%
1/6 • All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee * Stemline shall have the right to publish the results of the study * This is a multi-site study; therefore, publication of results from all sites is expected * Institution's (PI's) results may be submitted for publication only after multicenter results have been published, 18 months after study completion. * PI to submit copy of publication/presentation to Stemline for review/comment at least 60 days prior to submission for publication
- Publication restrictions are in place
Restriction type: OTHER