Trial Outcomes & Findings for A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer (NCT NCT03822871)
NCT ID: NCT03822871
Last Updated: 2024-03-21
Results Overview
The dose-limiting toxicity was defined as any of the following: 1. Grade 4 neutropenia lasting \> 5 consecutive days 2. Grade 3 or 4 febrile neutropenia 3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion 4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management 5. Any other treatment-related toxicity that results in delay of Cycle 2 administration of CTT1403 by \> 21 days and/or toxicity considered by the Investigator and Sponsor's medical representatives to be dose-limiting.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
6-8 weeks from time of injection on Cycle 1 - Day 1
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
0.75 GBq Cohort
0.75 GBq dose of CTT1403
|
1.5 GBq Cohort
1.5 GBq dose of CTT1403
|
2.0 GBq Cohort
2.0 GBq dose of CTT1403
|
3.0 GBq Cohort
3.0 GBq dose of CTT1403
|
4.5 GBq Cohort
4.5 GBq dose of CTT1403
|
6.0 GBq Cohort
6.0 GBq dose of CTT1403
|
7.5 GBq Cohort
7.5 GBq dose of CTT1403
|
9.0 GBq Cohort
9.0 GBq dose of CTT1403
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
3
|
4
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
3
|
4
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
0.75 GBq Cohort
n=1 Participants
0.75 GBq dose of CTT1403
|
1.5 GBq Cohort
n=1 Participants
1.5 GBq dose of CTT1403
|
2.0 GBq Cohort
n=1 Participants
2.0GBq dose of CTT1403
|
3.0 GBq Cohort
n=3 Participants
3.0 GBq dose of CTT1403
|
4.5 GBq Cohort
n=4 Participants
4.5 GBq dose of CTT1403
|
6.0 GBq Cohort
n=3 Participants
6.0 GBq dose of CTT1403
|
7.5 GBq Cohort
n=3 Participants
7.5 GBq dose of CTT1403
|
9.0 GBq Cohort
n=1 Participants
9.0 GBq dose of CTT1403
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
83 years
n=5 Participants
|
75 years
n=7 Participants
|
79 years
n=5 Participants
|
65 years
STANDARD_DEVIATION 7.55 • n=4 Participants
|
70 years
STANDARD_DEVIATION 2.58 • n=21 Participants
|
72 years
STANDARD_DEVIATION 7.81 • n=10 Participants
|
82 years
STANDARD_DEVIATION 1.00 • n=115 Participants
|
74 years
n=6 Participants
|
73.41 years
STANDARD_DEVIATION 7.37 • n=6 Participants
|
|
Sex: Female, Male
Female
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
16 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 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
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
15 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=10 Participants
|
3 participants
n=115 Participants
|
1 participants
n=6 Participants
|
17 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 6-8 weeks from time of injection on Cycle 1 - Day 1The dose-limiting toxicity was defined as any of the following: 1. Grade 4 neutropenia lasting \> 5 consecutive days 2. Grade 3 or 4 febrile neutropenia 3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion 4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management 5. Any other treatment-related toxicity that results in delay of Cycle 2 administration of CTT1403 by \> 21 days and/or toxicity considered by the Investigator and Sponsor's medical representatives to be dose-limiting.
Outcome measures
| Measure |
0.75 GBq Cohort
n=1 Participants
0.75 GBq dose of CTT1043
|
1.5 GBq Cohort
n=1 Participants
1.5 GBq dose of CTT1043
|
2.0 GBq Cohort
n=1 Participants
2.0 GBq dose of CTT1043
|
3.0 GBq Cohort
n=3 Participants
3.0 GBq dose of CTT1043
|
4.5 GBq Cohort
n=4 Participants
4.5 GBq dose of CTT1043
|
6.0 GBq Cohort
n=3 Participants
6.0 GBq dose of CTT1043
|
7.5 GBq Cohort
n=3 Participants
7.5 GBq dose of CTT1043
|
9.0 GBq Cohort
n=1 Participants
9.0 GBq dose of CTT1043
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403
Number of participants who experienced a dose-limiting toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403
Number of participants who did not experience a dose-limiting toxicity
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Cycle 1-Day 35, Cycle 2-Day 35, 30 Days After Last Dose, 8 Weeks Post-Treatment. Each cycle lasted 35 days.Population: In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew.
Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response.
Outcome measures
| Measure |
0.75 GBq Cohort
n=1 Participants
0.75 GBq dose of CTT1043
|
1.5 GBq Cohort
n=1 Participants
1.5 GBq dose of CTT1043
|
2.0 GBq Cohort
n=1 Participants
2.0 GBq dose of CTT1043
|
3.0 GBq Cohort
n=3 Participants
3.0 GBq dose of CTT1043
|
4.5 GBq Cohort
n=4 Participants
4.5 GBq dose of CTT1043
|
6.0 GBq Cohort
n=3 Participants
6.0 GBq dose of CTT1043
|
7.5 GBq Cohort
n=3 Participants
7.5 GBq dose of CTT1043
|
9.0 GBq Cohort
n=1 Participants
9.0 GBq dose of CTT1043
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with stable disease on Cycle 1-Day 35
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with progressive disease on Cycle 1-Day 35
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with stable disease on Cycle 2-Day 35
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with progressive disease on Cycle 2-Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with stable disease 30 days after last dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with progressive disease 30 days after last dose
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with stable disease 8 weeks post-treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate by RECIST v1.1 Criteria
Number of patients with progressive disease 8 weeks post-treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time.
Outcome measures
| Measure |
0.75 GBq Cohort
n=1 Participants
0.75 GBq dose of CTT1043
|
1.5 GBq Cohort
n=1 Participants
1.5 GBq dose of CTT1043
|
2.0 GBq Cohort
n=1 Participants
2.0 GBq dose of CTT1043
|
3.0 GBq Cohort
n=3 Participants
3.0 GBq dose of CTT1043
|
4.5 GBq Cohort
n=4 Participants
4.5 GBq dose of CTT1043
|
6.0 GBq Cohort
n=3 Participants
6.0 GBq dose of CTT1043
|
7.5 GBq Cohort
n=3 Participants
7.5 GBq dose of CTT1043
|
9.0 GBq Cohort
n=1 Participants
9.0 GBq dose of CTT1043
|
|---|---|---|---|---|---|---|---|---|
|
Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging
Mean absorbed dose per GBq - Left Kidney
|
0.608 Gy/GBq
|
0.611 Gy/GBq
|
0.760 Gy/GBq
|
1.024 Gy/GBq
Standard Deviation 0.428
|
0.579 Gy/GBq
Standard Deviation 0.127
|
0.518 Gy/GBq
Standard Deviation 0.072
|
0.774 Gy/GBq
Standard Deviation 0.199
|
0.699 Gy/GBq
|
|
Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging
Mean absorbed dose per GBq - Right Kidney
|
0593 Gy/GBq
|
0.585 Gy/GBq
|
1.021 Gy/GBq
|
1.032 Gy/GBq
Standard Deviation 0.550
|
0.638 Gy/GBq
Standard Deviation 0.108
|
0.477 Gy/GBq
Standard Deviation 0.064
|
0.731 Gy/GBq
Standard Deviation 0.279
|
0.677 Gy/GBq
|
SECONDARY outcome
Timeframe: Cycle 1-Day 1 and Cycle 2-Day 1. Each cycle lasted 35 days.Population: In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew.
The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable.
Outcome measures
| Measure |
0.75 GBq Cohort
0.75 GBq dose of CTT1043
|
1.5 GBq Cohort
1.5 GBq dose of CTT1043
|
2.0 GBq Cohort
2.0 GBq dose of CTT1043
|
3.0 GBq Cohort
n=1 Participants
3.0 GBq dose of CTT1043
|
4.5 GBq Cohort
n=3 Participants
4.5 GBq dose of CTT1043
|
6.0 GBq Cohort
n=1 Participants
6.0 GBq dose of CTT1043
|
7.5 GBq Cohort
n=2 Participants
7.5 GBq dose of CTT1043
|
9.0 GBq Cohort
9.0 GBq dose of CTT1043
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
Change in rating of average pain from Cycle 1-Day 1 to Cycle 2-Day 1 · Experienced no change in reported pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
Change in rating of pain at its worst in the past 24 hours from Cycle 1-Day 1 to Cycle 2-Day 1 · Experienced an increase in reported pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
Change in rating of pain at its worst in the past 24 hours from Cycle 1-Day 1 to Cycle 2-Day 1 · Experienced a decrease in reported pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
Change in rating of pain at its worst in the past 24 hours from Cycle 1-Day 1 to Cycle 2-Day 1 · Experienced no change in reported pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
Change in rating of average pain from Cycle 1-Day 1 to Cycle 2-Day 1 · Experienced an increase in reported pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index
Change in rating of average pain from Cycle 1-Day 1 to Cycle 2-Day 1 · Experienced a decrease in reported pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Samples were collected during Cycle 1 (timepoints start at the initiation of infusion): Day 1 (30 min +/- 5 min and 2 hrs +/- 30 min), Day 2 (24 hrs +/- 12 hrs), Day 3 (48 hrs +/- 12 hrs), Day 8 (168 hrs +/- 24 hrs), Day 15 (336 hrs +/- 24 hrs)Population: In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew.
The distribution half-life and the elimination half-life of CTT1403 were calculated.
Outcome measures
| Measure |
0.75 GBq Cohort
n=1 Participants
0.75 GBq dose of CTT1043
|
1.5 GBq Cohort
n=1 Participants
1.5 GBq dose of CTT1043
|
2.0 GBq Cohort
n=1 Participants
2.0 GBq dose of CTT1043
|
3.0 GBq Cohort
n=3 Participants
3.0 GBq dose of CTT1043
|
4.5 GBq Cohort
n=4 Participants
4.5 GBq dose of CTT1043
|
6.0 GBq Cohort
n=3 Participants
6.0 GBq dose of CTT1043
|
7.5 GBq Cohort
n=3 Participants
7.5 GBq dose of CTT1043
|
9.0 GBq Cohort
n=1 Participants
9.0 GBq dose of CTT1043
|
|---|---|---|---|---|---|---|---|---|
|
Assessment of Pharmacokinetics of CTT1403
Distribution half-life
|
—
|
0.747 hours
|
1.044 hours
|
0.699 hours
Standard Deviation 0.267
|
0.813 hours
Standard Deviation 0.068
|
0.680 hours
Standard Deviation 0.149
|
—
|
—
|
|
Assessment of Pharmacokinetics of CTT1403
Elimination half-life
|
—
|
28.881 hours
|
23.902 hours
|
29.616 hours
Standard Deviation 2.673
|
36.867 hours
Standard Deviation 4.531
|
38.173 hours
Standard Deviation 11.365
|
—
|
—
|
Adverse Events
0.75 GBq Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
1.5 GBq Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
2.0 GBq Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
3.0 GBq Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
4.5 GBq Cohort
Serious events: 1 serious events
Other events: 2 other events
Deaths: 4 deaths
6.0 GBq Cohort
Serious events: 1 serious events
Other events: 2 other events
Deaths: 3 deaths
7.5 GBq Cohort
Serious events: 1 serious events
Other events: 1 other events
Deaths: 3 deaths
9.0 GBq Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
0.75 GBq Cohort
n=1 participants at risk
0.75 GBq dose of CTT1403
|
1.5 GBq Cohort
n=1 participants at risk
1.5 GBq dose of CTT1403
|
2.0 GBq Cohort
n=1 participants at risk
2.0 GBq dose of CTT1403
|
3.0 GBq Cohort
n=3 participants at risk
3.0 GBq dose of CTT1403
|
4.5 GBq Cohort
n=4 participants at risk
4.5 GBq dose of CTT1403
|
6.0 GBq Cohort
n=3 participants at risk
6.0 GBq dose of CTT1403
|
7.5 GBq Cohort
n=3 participants at risk
7.5 GBq dose of CTT1403
|
9.0 GBq Cohort
n=1 participants at risk
9.0 GBq dose of CTT1403
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Grade 3 Fall
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
General disorders
Grade 3 Syncope
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Cardiac disorders
Grade 3 Atrial Fibrillation with Rapid Ventricular Response
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pulmonary Edema
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Blood and lymphatic system disorders
Grade 3 Hyponatremia
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Nervous system disorders
Grade 3 Cerebrovascular Accident
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
Other adverse events
| Measure |
0.75 GBq Cohort
n=1 participants at risk
0.75 GBq dose of CTT1403
|
1.5 GBq Cohort
n=1 participants at risk
1.5 GBq dose of CTT1403
|
2.0 GBq Cohort
n=1 participants at risk
2.0 GBq dose of CTT1403
|
3.0 GBq Cohort
n=3 participants at risk
3.0 GBq dose of CTT1403
|
4.5 GBq Cohort
n=4 participants at risk
4.5 GBq dose of CTT1403
|
6.0 GBq Cohort
n=3 participants at risk
6.0 GBq dose of CTT1403
|
7.5 GBq Cohort
n=3 participants at risk
7.5 GBq dose of CTT1403
|
9.0 GBq Cohort
n=1 participants at risk
9.0 GBq dose of CTT1403
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
General disorders
Diaphoresis
|
100.0%
1/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Taste changes
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
100.0%
1/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
100.0%
1/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Dry heave
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
General disorders
Abdominal malaise
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Decreased apetite
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
66.7%
2/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Renal and urinary disorders
Blood in urine
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
33.3%
1/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
100.0%
1/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Skin and subcutaneous tissue disorders
Periorbital swelling
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Gastrointestinal disorders
Intermittent bloating
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
25.0%
1/4 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/3 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
0.00%
0/1 • Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
|
Additional Information
Dr. Beatrice Langton-Webster, CEO
Cancer Targeted Technology
Phone: (206) 617-0699
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results for a period that is less than or equal to 45 days prior to submission for publication or disclosure to a third party. If sponsor believes patentable subject matter is disclosed, it shall, within 30 days of receipt, notify university and publication or disclosure will be withheld for a period of up to 90 days from date of receipt or until university and sponsor agree that no patentable invention exists, whichever period is shorter.
- Publication restrictions are in place
Restriction type: OTHER