Trial Outcomes & Findings for Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC (NCT NCT05166577)
NCT ID: NCT05166577
Last Updated: 2025-03-12
Results Overview
Percentage of patients experiencing a DLT, defined as an adverse event or clinically significant abnormal laboratory value that is at least possibly related to study drugs and is not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
DLT period of 28 days
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
Dose Cohort 1
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
3
|
4
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
3
|
4
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC
Baseline characteristics by cohort
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=4 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
n=3 Participants
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
n=6 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43 Years
n=5 Participants
|
52 Years
n=7 Participants
|
42 Years
n=5 Participants
|
54 Years
n=4 Participants
|
51 Years
n=21 Participants
|
48 Years
n=8 Participants
|
55 Years
n=8 Participants
|
50 Years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
21 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
21 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 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
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
1 Participants
n=8 Participants
|
3 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
|
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
|
|
Tumor Type
EBV+ Nasopharyngeal Carcinoma
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Tumor Type
Other EBV+ Cancer
|
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
|
PRIMARY outcome
Timeframe: DLT period of 28 daysPopulation: Phase 1b safety analysis population, defined as all patients with recurrent or metastatic EBV+ nasopharyngeal carcinoma who received at least one dose of study treatment in Phase 1b
Percentage of patients experiencing a DLT, defined as an adverse event or clinically significant abnormal laboratory value that is at least possibly related to study drugs and is not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=4 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
n=3 Participants
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
n=6 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Phase 1b: Incidence of Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 yearsPopulation: The clinical trial was terminated before participants were enrolled in Phase 2
Percentage of patients with a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsPopulation: Safety analysis population, defined as all patients who received at least one dose of study treatment
Percentage of patients experiencing at least one treatment-emergent adverse event (AE), defined as those AEs with onset after the first dose of study drug or existing events that worsened after the first dose during the study
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=4 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
n=3 Participants
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
n=6 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Incidence of Adverse Events
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 yearsPopulation: The clinical trial was terminated before participants were enrolled in Phase 2
Interval of time from the date of first observed CR or PR to the date of documented disease progression or death due to any cause, whichever occurs first
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsPopulation: The clinical trial was terminated before participants were enrolled in Phase 2
Percentage of patients having a CR, PR, or stable disease at any time during treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsPopulation: The clinical trial was terminated before participants were enrolled in Phase 2
Interval of time from the start of study drug treatment to the date of first documented disease progression or death from any cause, whichever occurs first
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsPopulation: The clinical trial was terminated before participants were enrolled in Phase 2
Interval of time from the start of study drug treatment to date of death for any reason
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the time required to reach peak plasma concentration \[Cmax\] after nanatinostat administration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Nanatinostat) - Time to Maximum Plasma Concentration [Tmax]
|
2 hours
Interval 1.0 to 4.0
|
1 hours
Interval 1.0 to 1.0
|
1 hours
Interval 1.0 to 2.0
|
4 hours
Interval 1.0 to 6.0
|
7 hours
Interval 2.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the time required to reach peak plasma concentration \[Cmax\] after valganciclovir administration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Ganciclovir) - Time to Maximum Plasma Concentration [Tmax]
|
2 hours
Interval 2.0 to 6.0
|
2 hours
Interval 2.0 to 2.0
|
2 hours
Interval 2.0 to 4.0
|
2 hours
Interval 2.0 to 4.0
|
2 hours
Interval 1.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the peak plasma concentration \[Cmax\] after nanatinostat administration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Nanatinostat) - Maximum Plasma Concentration [Cmax]
|
136 ng/mL
Geometric Coefficient of Variation 137
|
391 ng/mL
Geometric Coefficient of Variation 26.7
|
214 ng/mL
Geometric Coefficient of Variation 44.8
|
96.1 ng/mL
Geometric Coefficient of Variation 33.2
|
110 ng/mL
Geometric Coefficient of Variation 53.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the peak plasma concentration \[Cmax\] after valganciclovir administration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Ganciclovir) - Maximum Plasma Concentration [Cmax]
|
4420 ng/mL
Geometric Coefficient of Variation 3.49
|
5860 ng/mL
Geometric Coefficient of Variation 32.1
|
5210 ng/mL
Geometric Coefficient of Variation 80.9
|
7580 ng/mL
Geometric Coefficient of Variation 32.6
|
4860 ng/mL
Geometric Coefficient of Variation 27.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the area under the concentration-time curve from time 0 to the last measurable nanatinostat concentration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Nanatinostat) - Area Under the Plasma Concentration-Time Curve [AUC0-t]
|
362 ng*h/mL
Geometric Coefficient of Variation 82.2
|
751 ng*h/mL
Geometric Coefficient of Variation 12.7
|
896 ng*h/mL
Geometric Coefficient of Variation 39.0
|
416 ng*h/mL
Geometric Coefficient of Variation 12.3
|
465 ng*h/mL
Geometric Coefficient of Variation 67.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 1 valid PK concentration. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the area under the concentration-time curve from time 0 to the last measurable ganciclovir concentration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=3 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Ganciclovir) - Area Under the Plasma Concentration-Time Curve [AUC0-t]
|
37200 ng*h/mL
Geometric Coefficient of Variation 36.9
|
46700 ng*h/mL
Geometric Coefficient of Variation 12.1
|
30900 ng*h/mL
Geometric Coefficient of Variation 106
|
44400 ng*h/mL
Geometric Coefficient of Variation 24.8
|
38200 ng*h/mL
Geometric Coefficient of Variation 13.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of nanatinostat on Cycle 2 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the time required to reduce nanatinostat plasma concentration by 50% after nanatinostat administration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=2 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=1 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=1 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Nanatinostat) - Half-Life of Nanatinostat [t1/2]
|
2.11 hours
Standard Deviation 0.136
|
1.43 hours
Standard Deviation 0.149
|
2.64 hours
Standard Deviation 1.90
|
2.76 hours
Standard Deviation 0
|
5.29 hours
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 days following enrollmentPopulation: PK analysis population, defined as all patients who received at least 1 dose of valganciclovir on Cycle 2 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. The clinical trial was terminated before the outcome measure data were collected for Dose Cohort 6 and Dose Cohort 7.
Defined as the time required to reduce ganciclovir plasma concentration by 50% after valganciclovir administration on Cycle 2 Day 1
Outcome measures
| Measure |
Dose Cohort 1
n=2 Participants
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=3 Participants
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=2 Participants
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 Participants
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 Participants
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter (Ganciclovir) - Half-Life of Ganciclovir [t1/2]
|
6.88 hours
Standard Deviation 0.115
|
7.18 hours
Standard Deviation 1.48
|
5.64 hours
Standard Deviation 2.08
|
5.74 hours
Standard Deviation 0.601
|
6.07 hours
Standard Deviation 1.55
|
—
|
—
|
Adverse Events
Dose Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Cohort 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Cohort 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Cohort 5
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Cohort 6
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Cohort 7
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Cohort 1
n=3 participants at risk
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=4 participants at risk
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 participants at risk
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 participants at risk
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 participants at risk
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
n=3 participants at risk
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
n=6 participants at risk
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
Other adverse events
| Measure |
Dose Cohort 1
n=3 participants at risk
Nanatinostat 20 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 2
n=4 participants at risk
Nanatinostat 30 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 3
n=3 participants at risk
Nanatinostat 40 mg once daily, Days 1-4/week Valganciclovir 900 mg once daily
|
Dose Cohort 4
n=3 participants at risk
Nanatinostat 10 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 5
n=4 participants at risk
Nanatinostat 20 mg and 10 mg divided dose, Days 1-4/week Valganciclovir 900 mg twice daily x 21 days then once daily
|
Dose Cohort 6
n=3 participants at risk
Nanatinostat 20 mg and 20 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
Dose Cohort 7
n=6 participants at risk
Nanatinostat 20 mg and 10 mg divided dose, Days 1-7/week Valganciclovir 450 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Approximately 3 years
|
50.0%
2/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
75.0%
3/4 • Approximately 3 years
|
100.0%
3/3 • Approximately 3 years
|
100.0%
6/6 • Approximately 3 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • Approximately 3 years
|
50.0%
2/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
50.0%
2/4 • Approximately 3 years
|
100.0%
3/3 • Approximately 3 years
|
100.0%
6/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Approximately 3 years
|
50.0%
2/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
100.0%
3/3 • Approximately 3 years
|
83.3%
5/6 • Approximately 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
100.0%
3/3 • Approximately 3 years
|
83.3%
5/6 • Approximately 3 years
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
50.0%
2/4 • Approximately 3 years
|
100.0%
3/3 • Approximately 3 years
|
100.0%
6/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
75.0%
3/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
50.0%
3/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
50.0%
3/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
100.0%
3/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Approximately 3 years
|
50.0%
2/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
50.0%
3/6 • Approximately 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
50.0%
3/6 • Approximately 3 years
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
75.0%
3/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
50.0%
3/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
50.0%
3/6 • Approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Contusion
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
25.0%
1/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
66.7%
2/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
33.3%
2/6 • Approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
50.0%
2/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/6 • Approximately 3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/3 • Approximately 3 years
|
0.00%
0/4 • Approximately 3 years
|
33.3%
1/3 • Approximately 3 years
|
16.7%
1/6 • Approximately 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60