Trial Outcomes & Findings for Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer (NCT NCT00826150)
NCT ID: NCT00826150
Last Updated: 2019-06-13
Results Overview
A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-06-13
Participant Flow
Clinical sites
Participant milestones
| Measure |
BC-819 60 mg IP
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses/ 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer
Baseline characteristics by cohort
| Measure |
BC-819 60 mp IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
Total
n=14 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 12 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
14 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Per Protocol data set (PP): 11 subjects who met the study inclusion and exclusion criteria, received at least one course of treatment of the investigational product and had a follow-up disease assessment comprised the PP set (5 subjects from the 60 mg cohort, 3 subjects from the 120 mg cohort; 3 subjects from the 240 mg cohort).
A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.
Outcome measures
| Measure |
BC-819 60 mg IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 17.5 monthsPopulation: Intent to Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
Outcome measures
| Measure |
BC-819 60 mg IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Overall Survival in ITT Population
|
3.2 Months
Interval 1.6 to 16.7
|
5.3 Months
Interval 3.2 to 8.3
|
6.5 Months
Interval 1.6 to 16.7
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT. 13 patients of the ITT population (n=14) were evaluated (one patient was not assessed for solid tumor response in the BC-819 60 mg IP Arm).
If measurable disease was present, then the response of each marker lesion was evaluated separately and rated for response according to RECIST criteria for solid tumors. Complete Response: Disappearance of the target lesion. Partial Response: At least a 30% decrease in the longest diameter of the target lesion. Stable Disease: No sufficient shrinkage to qualify for partial response, or sufficient increase to qualify for progressive disease. Progressive Disease: At least a 20% increase in the longest diameter of the target lesion.
Outcome measures
| Measure |
BC-819 60 mg IP
n=7 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Solid Tumor Response
Not evaluable
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Solid Tumor Response
Stable Disease
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Solid Tumor Response
Progressive Disease
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusionPopulation: Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Outcome measures
| Measure |
BC-819 60 mg IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - T1/2 (Hours)
|
12.41 hours
Standard Deviation 5.24
|
21.98 hours
Standard Deviation 12.71
|
42.04 hours
Standard Deviation 58.52
|
SECONDARY outcome
Timeframe: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusionPopulation: Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Outcome measures
| Measure |
BC-819 60 mg IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Systemic BC-819 Pharmacokinetics (PK) - Maximum Observed Plasma Concentration (Cmax)
|
830000 copies/μL
Standard Deviation 640000
|
750000 copies/μL
Standard Deviation 1050000
|
430000 copies/μL
Standard Deviation 340000
|
SECONDARY outcome
Timeframe: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusionPopulation: Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Outcome measures
| Measure |
BC-819 60 mg IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - Tmax (Hours)
|
6.00 hours
Standard Deviation 2.14
|
2.67 hours
Standard Deviation 1.16
|
9.33 hours
Standard Deviation 12.70
|
SECONDARY outcome
Timeframe: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusionPopulation: Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Outcome measures
| Measure |
BC-819 60 mg IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUClast
|
1600000 copies*hr/μl
Standard Deviation 1700000
|
10600000 copies*hr/μl
Standard Deviation 15100000
|
5300000 copies*hr/μl
Standard Deviation 1900000
|
SECONDARY outcome
Timeframe: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusionPopulation: Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Outcome measures
| Measure |
BC-819 60 mg IP
n=8 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUCinf
|
1900000 copies*hr/μl
Standard Deviation 1900000
|
16200000 copies*hr/μl
Standard Deviation 24400000
|
12500000 copies*hr/μl
Standard Deviation 9800000
|
SECONDARY outcome
Timeframe: 17.5 monthsPopulation: Per Protocol data set (PP): 11 subjects who met the study inclusion and exclusion criteria, received at least one course of treatment of the investigational product and had a follow-up disease assessment comprised the PP set (5 subjects from the 60 mg cohort, 3 subjects from the 120 mg cohort; 3 subjects from the 240 mg cohort).
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
Outcome measures
| Measure |
BC-819 60 mg IP
n=5 Participants
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 Participants
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 Participants
240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Overall Survival in PP
|
3.9 months
Interval 3.1 to 16.7
|
5.3 months
Interval 3.2 to 8.3
|
6.5 months
Interval 4.5 to 7.4
|
Adverse Events
BC-819 60 mg IP
Serious events: 6 serious events
Other events: 8 other events
Deaths: 3 deaths
BC-819 120 mg IP
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BC-819 240 mg IP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BC-819 60 mg IP
n=8 participants at risk
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 participants at risk
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 participants at risk
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Elevated liver enzymes
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
General disorders
Clinical deterioration
|
37.5%
3/8 • Number of events 3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Renal and urinary disorders
Recurrent urinary tract infection
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Respiratory, thoracic and mediastinal disorders
Weakness and shortness of breath
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Infections and infestations
Infection of port
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Cardiac disorders
Chest pain and dyspnea
|
0.00%
0/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
Other adverse events
| Measure |
BC-819 60 mg IP
n=8 participants at risk
60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 120 mg IP
n=3 participants at risk
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
BC-819 240 mg IP
n=3 participants at risk
120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac disorder
|
12.5%
1/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
75.0%
6/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
General disorders
General disorders and administration site conditions
|
62.5%
5/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
100.0%
3/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Infections and infestations
Infections
|
12.5%
1/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
37.5%
3/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Investigations
|
100.0%
8/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
100.0%
3/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
100.0%
3/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
2/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Nervous system disorders
Hedache
|
25.0%
2/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
50.0%
4/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
6/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
General disorders
Asthenia
|
50.0%
4/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
General disorders
General physical health deterioration
|
25.0%
2/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
2/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Renal and urinary disorders
Urinary tract infection
|
37.5%
3/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Vascular disorders
Vascular disorders
|
12.5%
1/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
50.0%
4/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
3/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
4/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Blood albumin decreased
|
25.0%
2/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Blood calcium decreased
|
37.5%
3/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
100.0%
3/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Blood potassium increased
|
37.5%
3/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
Haemoglobin decreased
|
37.5%
3/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
33.3%
1/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
International normalised ratio increased
|
25.0%
2/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
0.00%
0/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
66.7%
2/3 • Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place