Trial Outcomes & Findings for A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection (NCT NCT03834740)
NCT ID: NCT03834740
Last Updated: 2025-05-30
Results Overview
Highest dose of each drug that did not cause a DLT in \>17% of participants
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
27 participants
Primary outcome timeframe
From the date of the first dose given until the second documented DLT, assessed up to 24 months
Results posted on
2025-05-30
Participant Flow
27 enrolled participants were assigned to 1 of 7 different dose escalation levels of ribociclib plus everolimus. For all levels, ribo doses were administered orally QD for five days. For levels 0-3, eve doses were administered orally QD for five days. For levels 4-6, a single dose of eve was administered once on day 5. Participants were also assigned to 1 of 3 time interval cohorts, each with a different timing for the administration of the final dose combination before brain tumor resection.
Participant milestones
| Measure |
Time Cohort 1: Final Dose 1 to 3 Hours Prior to Craniotomy
The final of five ribociclib+everolimus doses administered orally 1 to 3 hours prior to craniotomy for tumor resection
|
Time Cohort 2: Final Dose 7 to 9 Hours Prior to Craniotomy
The final of five ribociclib+everolimus doses administered orally 7 to 9 hours prior to craniotomy for tumor resection
|
Time Cohort 3: Final Dose 23 to 25 Hours Prior to Craniotomy
The final of five ribociclib+everolimus doses administered orally 23 to 25 hours prior to craniotomy for tumor resection
|
|---|---|---|---|
|
Ribo 400mg+Eve 2.5mg QD
STARTED
|
2
|
2
|
2
|
|
Ribo 400mg+Eve 2.5mg QD
COMPLETED
|
2
|
2
|
2
|
|
Ribo 400mg+Eve 2.5mg QD
NOT COMPLETED
|
0
|
0
|
0
|
|
Ribo 600mg+Eve 2.5mg QD
STARTED
|
1
|
2
|
0
|
|
Ribo 600mg+Eve 2.5mg QD
COMPLETED
|
1
|
2
|
0
|
|
Ribo 600mg+Eve 2.5mg QD
NOT COMPLETED
|
0
|
0
|
0
|
|
Ribo 600mg+Eve 5mg QD
STARTED
|
0
|
3
|
0
|
|
Ribo 600mg+Eve 5mg QD
COMPLETED
|
0
|
3
|
0
|
|
Ribo 600mg+Eve 5mg QD
NOT COMPLETED
|
0
|
0
|
0
|
|
Ribo 600mg+Eve 10mg QD
STARTED
|
0
|
4
|
0
|
|
Ribo 600mg+Eve 10mg QD
COMPLETED
|
0
|
4
|
0
|
|
Ribo 600mg+Eve 10mg QD
NOT COMPLETED
|
0
|
0
|
0
|
|
Ribo 600mg QD+Eve 50mg Once
STARTED
|
0
|
4
|
0
|
|
Ribo 600mg QD+Eve 50mg Once
COMPLETED
|
0
|
4
|
0
|
|
Ribo 600mg QD+Eve 50mg Once
NOT COMPLETED
|
0
|
0
|
0
|
|
Ribo 600mg QD+Eve 60mg Once
STARTED
|
0
|
3
|
0
|
|
Ribo 600mg QD+Eve 60mg Once
COMPLETED
|
0
|
3
|
0
|
|
Ribo 600mg QD+Eve 60mg Once
NOT COMPLETED
|
0
|
0
|
0
|
|
Ribo 600mg QD+Eve 70mg Once
STARTED
|
0
|
4
|
0
|
|
Ribo 600mg QD+Eve 70mg Once
COMPLETED
|
0
|
3
|
0
|
|
Ribo 600mg QD+Eve 70mg Once
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Time Cohort 1: Final Dose 1 to 3 Hours Prior to Craniotomy
The final of five ribociclib+everolimus doses administered orally 1 to 3 hours prior to craniotomy for tumor resection
|
Time Cohort 2: Final Dose 7 to 9 Hours Prior to Craniotomy
The final of five ribociclib+everolimus doses administered orally 7 to 9 hours prior to craniotomy for tumor resection
|
Time Cohort 3: Final Dose 23 to 25 Hours Prior to Craniotomy
The final of five ribociclib+everolimus doses administered orally 23 to 25 hours prior to craniotomy for tumor resection
|
|---|---|---|---|
|
Ribo 600mg QD+Eve 70mg Once
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection
Baseline characteristics by cohort
| Measure |
Dose Level 0: Ribo 400mg+Eve 2.5mg QD
n=6 Participants
Dose Level 0: Ribo 400mg+Eve 2.5mg QD and all 3 Time Cohorts were combined
|
Dose Level 1: Ribo 600mg+Eve 2.5mg QD
n=3 Participants
Dose Level 1: Ribo 600mg+Eve 2.5mg QD of participants in both Time Cohorts 1 and 2 as only 1 participant in Time Cohort 1 at this dose level
|
Dose Level 2: Ribo 600mg+Eve 5mg QD
n=3 Participants
Dose Level 2: Ribo 600mg+Eve 5mg QD of participants in Time Cohort 2
|
Dose Level 3: Ribo 600mg+Eve 10mg QD
n=4 Participants
Dose Level 3: Ribo 600mg+Eve 10mg QD of participants in Time Cohort 2
|
Dose Level 4: Ribo 600mg QD+Eve 50mg Once
n=4 Participants
Dose Level 4: Ribo 600mg QD+Eve 50mg Once of participants in Time Cohort 2
|
Dose Level 5: Ribo 600mg QD+Eve 60mg Once
n=3 Participants
Dose Level 5: Ribo 600mg QD+Eve 60mg Once of participants in Time Cohort 2
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
n=4 Participants
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Age, Continuous
|
54 Years
n=5 Participants
|
58 Years
n=7 Participants
|
65 Years
n=5 Participants
|
54.5 Years
n=4 Participants
|
68 Years
n=21 Participants
|
61 Years
n=8 Participants
|
49 Years
n=8 Participants
|
58 Years
n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose given until the second documented DLT, assessed up to 24 monthsPopulation: Enrolled participants
Highest dose of each drug that did not cause a DLT in \>17% of participants
Outcome measures
| Measure |
All Participants
n=24 Participants
All participants enrolled in the clinical trial.
|
Ribociclib 600mg Dose
Ribociclib 600mg QD 5 days
|
Everolimus 10mg Dose
Everolimus 10mg QD 5 days
|
Everolimus 50mg Dose
Everolimus 50mg single dose
|
Everolimus 60mg Dose
Everolimus 60mg single dose
|
Everolimus 70mg Dose
Everolimus 70mg single dose
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
Ribociclib, once daily
|
600 milligrams
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose (MTD)
Everolimus, once weekly
|
70 milligrams
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0-24 hours after the last doseTotal ribociclib concentrations in non-enhancing and contrast-enhancing tumor tissue samples using validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method and equilibrium dialysis
Outcome measures
| Measure |
All Participants
n=6 Participants
All participants enrolled in the clinical trial.
|
Ribociclib 600mg Dose
n=18 Participants
Ribociclib 600mg QD 5 days
|
Everolimus 10mg Dose
Everolimus 10mg QD 5 days
|
Everolimus 50mg Dose
Everolimus 50mg single dose
|
Everolimus 60mg Dose
Everolimus 60mg single dose
|
Everolimus 70mg Dose
Everolimus 70mg single dose
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis - Total Ribociclib Concentration
Non-Enhancing Tissue
|
3132 nanomolar
Interval 1372.0 to 14954.0
|
8193 nanomolar
Interval 1314.0 to 41638.0
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Analysis - Total Ribociclib Concentration
Enhancing Tissue
|
4056 nanomolar
Interval 2332.0 to 9900.0
|
14142 nanomolar
Interval 753.0 to 49449.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0-24 hours after the last doseUnbound ribociclib concentrations in non-enhancing and contrast-enhancing tumor tissue samples using validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method and equilibrium dialysis
Outcome measures
| Measure |
All Participants
n=6 Participants
All participants enrolled in the clinical trial.
|
Ribociclib 600mg Dose
n=18 Participants
Ribociclib 600mg QD 5 days
|
Everolimus 10mg Dose
Everolimus 10mg QD 5 days
|
Everolimus 50mg Dose
Everolimus 50mg single dose
|
Everolimus 60mg Dose
Everolimus 60mg single dose
|
Everolimus 70mg Dose
Everolimus 70mg single dose
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis - Unbound Ribociclib Concentration
Non-Enhancing Tissue
|
170 nanomolar
Interval 65.0 to 1770.0
|
634 nanomolar
Interval 68.0 to 2345.0
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Analysis - Unbound Ribociclib Concentration
Enhancing Tissue
|
375 nanomolar
Interval 158.0 to 1405.0
|
1017 nanomolar
Interval 133.0 to 4500.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0-24 hours after the last doseTotal everolimus concentrations in non-enhancing and contrast-enhancing tumor tissue samples using validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method and equilibrium dialysis
Outcome measures
| Measure |
All Participants
n=9 Participants
All participants enrolled in the clinical trial.
|
Ribociclib 600mg Dose
n=3 Participants
Ribociclib 600mg QD 5 days
|
Everolimus 10mg Dose
n=3 Participants
Everolimus 10mg QD 5 days
|
Everolimus 50mg Dose
n=3 Participants
Everolimus 50mg single dose
|
Everolimus 60mg Dose
n=3 Participants
Everolimus 60mg single dose
|
Everolimus 70mg Dose
n=3 Participants
Everolimus 70mg single dose
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis - Total Everolimus Concentration
Non-Enhancing Tissue
|
2.9 nanomolar
Interval 0.2 to 35.3
|
10.3 nanomolar
Interval 9.2 to 20.2
|
4.75 nanomolar
Interval 1.8 to 33.3
|
6.3 nanomolar
Interval 2.4 to 25.1
|
13.8 nanomolar
Interval 11.3 to 36.1
|
8.2 nanomolar
Interval 6.8 to 78.2
|
—
|
|
Pharmacokinetic Analysis - Total Everolimus Concentration
Enhancing Tissue
|
4.4 nanomolar
Interval 0.2 to 83.5
|
16.6 nanomolar
Interval 11.1 to 39.8
|
14.1 nanomolar
Interval 0.2 to 61.3
|
53.05 nanomolar
Interval 1.7 to 74.1
|
30.4 nanomolar
Interval 9.8 to 87.6
|
71.8 nanomolar
Interval 31.2 to 90.0
|
—
|
PRIMARY outcome
Timeframe: 0-24 hours after the last dosePopulation: Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
Unbound everolimus concentrations in non-enhancing and contrast-enhancing tumor tissue samples using validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method and equilibrium dialysis
Outcome measures
| Measure |
All Participants
n=9 Participants
All participants enrolled in the clinical trial.
|
Ribociclib 600mg Dose
n=3 Participants
Ribociclib 600mg QD 5 days
|
Everolimus 10mg Dose
n=3 Participants
Everolimus 10mg QD 5 days
|
Everolimus 50mg Dose
n=3 Participants
Everolimus 50mg single dose
|
Everolimus 60mg Dose
n=3 Participants
Everolimus 60mg single dose
|
Everolimus 70mg Dose
n=3 Participants
Everolimus 70mg single dose
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis - Unbound Everolimus Concentration
Non-Enhancing Tissue
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
—
|
|
Pharmacokinetic Analysis - Unbound Everolimus Concentration
Enhancing Tissue
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
NA nanomolar
Results are below the lower limit of quantitation (BLQ) (\< 0.1 nM)
|
—
|
PRIMARY outcome
Timeframe: Baseline, IntraoperativelyPopulation: 3 participants of 27 enrolled were not included in analysis due to pseudoprogression (dose levels 3, 4, and 6), and an additional 1 participant was excluded due to insufficient tumor content in the resected tissue sample (dose level 6).
The percentage change of pRB positive cells in resected post-treatment recurrent GBM tumor tissue compared to baseline (archival primary GBM tumor tissue collected at screening). A positive PD effect is defined as \>30% decrease in pRB+ cells.
Outcome measures
| Measure |
All Participants
n=6 Participants
All participants enrolled in the clinical trial.
|
Ribociclib 600mg Dose
n=3 Participants
Ribociclib 600mg QD 5 days
|
Everolimus 10mg Dose
n=3 Participants
Everolimus 10mg QD 5 days
|
Everolimus 50mg Dose
n=3 Participants
Everolimus 50mg single dose
|
Everolimus 60mg Dose
n=3 Participants
Everolimus 60mg single dose
|
Everolimus 70mg Dose
n=3 Participants
Everolimus 70mg single dose
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
n=2 Participants
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
% Change of pRB+ Cells in Resected Post-Treatment rGMB Tissue vs Baseline Tissue
|
34 Percentage Change of pRB+ Cells
Interval -74.0 to 586.0
|
25 Percentage Change of pRB+ Cells
Interval -84.0 to 544.0
|
268 Percentage Change of pRB+ Cells
Interval 24.0 to 381.0
|
-88 Percentage Change of pRB+ Cells
Interval -98.0 to -55.0
|
-64 Percentage Change of pRB+ Cells
Interval -90.0 to 203.0
|
-80 Percentage Change of pRB+ Cells
Interval -85.0 to 115.0
|
96 Percentage Change of pRB+ Cells
Interval -74.0 to 266.0
|
PRIMARY outcome
Timeframe: Baseline, IntraoperativelyPopulation: 3 participants of 27 enrolled were not included in analysis due to pseudoprogression (dose levels 3, 4, and 6) and an additional 1 participant was excluded due to insufficient tumor content in the resected tissue sample (dose level 6).
The percentage change of pS6 positive cells in resected post-treatment recurrent GBM tumor tissue compared to baseline (archival primary GBM tumor tissue collected at screening). A positive PD effect is defined as \>30% decrease in pS6+ cells.
Outcome measures
| Measure |
All Participants
n=6 Participants
All participants enrolled in the clinical trial.
|
Ribociclib 600mg Dose
n=3 Participants
Ribociclib 600mg QD 5 days
|
Everolimus 10mg Dose
n=3 Participants
Everolimus 10mg QD 5 days
|
Everolimus 50mg Dose
n=3 Participants
Everolimus 50mg single dose
|
Everolimus 60mg Dose
n=3 Participants
Everolimus 60mg single dose
|
Everolimus 70mg Dose
n=3 Participants
Everolimus 70mg single dose
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
n=2 Participants
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
% Change of pS6+ Cells in Resected Post-Treatment rGMB Tissue vs Baseline Tissue
|
242 Percentage Change of pS6+ Cells
Interval 13.0 to 423.0
|
-10 Percentage Change of pS6+ Cells
Interval -31.0 to -4.0
|
330 Percentage Change of pS6+ Cells
Interval 234.0 to 626.0
|
-8 Percentage Change of pS6+ Cells
Interval -63.0 to 21.0
|
431 Percentage Change of pS6+ Cells
Interval -67.0 to 1365.0
|
-17 Percentage Change of pS6+ Cells
Interval -55.0 to 88.0
|
-74 Percentage Change of pS6+ Cells
Interval -77.0 to 88.0
|
SECONDARY outcome
Timeframe: From date of the first Phase 2 dose until the first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsPopulation: No participants were eligible for Phase 2 enrollment
From date of the first Phase 2 dose until the first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of surgery to date of death from any cause, assessed up to 60 monthsPopulation: No participants were eligible for Phase 2 enrollment
From date of surgery to date of death from any cause, assessed up to 60 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of the first Phase 2 dose until the first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsPopulation: No participants were eligible for Phase 2 enrollment
From date of the first Phase 2 dose until the first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 0: Ribo 400mg+Eve 2.5mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 1: Ribo 600mg+Eve 2.5mg QD
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2: Ribo 600mg+Eve 5mg QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 3: Ribo 600mg+Eve 10mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 4: Ribo 600mg QD+Eve 50mg Once
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 5: Ribo 600mg QD+Eve 60mg Once
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 0: Ribo 400mg+Eve 2.5mg QD
n=6 participants at risk
Dose Level 0: Ribo 400mg+Eve 2.5mg QD and all 3 Time Cohorts were combined
|
Dose Level 1: Ribo 600mg+Eve 2.5mg QD
n=3 participants at risk
Dose Level 1: Ribo 600mg+Eve 2.5mg QD of participants in both Time Cohorts 1 and 2 as only 1 participant in Time Cohort 1 at this dose level
|
Dose Level 2: Ribo 600mg+Eve 5mg QD
n=3 participants at risk
Dose Level 2: Ribo 600mg+Eve 5mg QD of participants in Time Cohort 2
|
Dose Level 3: Ribo 600mg+Eve 10mg QD
n=4 participants at risk
Dose Level 3: Ribo 600mg+Eve 10mg QD of participants in Time Cohort 2
|
Dose Level 4: Ribo 600mg QD+Eve 50mg Once
n=4 participants at risk
Dose Level 4: Ribo 600mg QD+Eve 50mg Once of participants in Time Cohort 2
|
Dose Level 5: Ribo 600mg QD+Eve 60mg Once
n=3 participants at risk
Dose Level 5: Ribo 600mg QD+Eve 60mg Once of participants in Time Cohort 2
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
n=4 participants at risk
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Brain edema
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
66.7%
2/3 • Number of events 4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
66.7%
2/3 • Number of events 3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
66.7%
2/3 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Infections and infestations
Infection
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
Other adverse events
| Measure |
Dose Level 0: Ribo 400mg+Eve 2.5mg QD
n=6 participants at risk
Dose Level 0: Ribo 400mg+Eve 2.5mg QD and all 3 Time Cohorts were combined
|
Dose Level 1: Ribo 600mg+Eve 2.5mg QD
n=3 participants at risk
Dose Level 1: Ribo 600mg+Eve 2.5mg QD of participants in both Time Cohorts 1 and 2 as only 1 participant in Time Cohort 1 at this dose level
|
Dose Level 2: Ribo 600mg+Eve 5mg QD
n=3 participants at risk
Dose Level 2: Ribo 600mg+Eve 5mg QD of participants in Time Cohort 2
|
Dose Level 3: Ribo 600mg+Eve 10mg QD
n=4 participants at risk
Dose Level 3: Ribo 600mg+Eve 10mg QD of participants in Time Cohort 2
|
Dose Level 4: Ribo 600mg QD+Eve 50mg Once
n=4 participants at risk
Dose Level 4: Ribo 600mg QD+Eve 50mg Once of participants in Time Cohort 2
|
Dose Level 5: Ribo 600mg QD+Eve 60mg Once
n=3 participants at risk
Dose Level 5: Ribo 600mg QD+Eve 60mg Once of participants in Time Cohort 2
|
Dose Level 6: Ribo 600mg QD+Eve 70mg Once
n=4 participants at risk
Dose Level 6: Ribo 600mg QD+Eve 70mg Once of participants in Time Cohort 2
|
|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
50.0%
2/4 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
66.7%
2/3 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
66.7%
2/3 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
50.0%
2/4 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
66.7%
2/3 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
33.3%
1/3 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
25.0%
1/4 • Number of events 1 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
50.0%
2/4 • Number of events 2 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/3 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
0.00%
0/4 • From the first date of study drug administration up to 30 days after the last date of study drug administration, assessed up to 37 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place