Trial Outcomes & Findings for Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer (NCT NCT03704688)
NCT ID: NCT03704688
Last Updated: 2025-05-16
Results Overview
In the Phase I portion of the study, a standard 3+3 design will be used to find the maximum tolerated dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
maximum of 18 months
Results posted on
2025-05-16
Participant Flow
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
Participant milestones
| Measure |
Phase I: Dose Level -3
Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily
Trametinib 0.5 mg: 0.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -2
Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 1 MG: 1.0 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -1
Trametinib 1.5 mg PO q daily 15mg PO q daily
Trametinib 1.5 MG: 1.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 1
Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 2
Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 30 MG: 30mg PO q daily
|
Phase II
Maximum tolerated dose as established in Phase I portion
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
7
|
5
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
7
|
5
|
0
|
Reasons for withdrawal
| Measure |
Phase I: Dose Level -3
Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily
Trametinib 0.5 mg: 0.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -2
Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 1 MG: 1.0 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -1
Trametinib 1.5 mg PO q daily 15mg PO q daily
Trametinib 1.5 MG: 1.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 1
Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 2
Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 30 MG: 30mg PO q daily
|
Phase II
Maximum tolerated dose as established in Phase I portion
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
4
|
1
|
0
|
|
Overall Study
Disease Progression
|
0
|
0
|
0
|
3
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase I: Dose Level -3
Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily
Trametinib 0.5 mg: 0.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -2
Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 1 MG: 1.0 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -1
Trametinib 1.5 mg PO q daily 15mg PO q daily
Trametinib 1.5 MG: 1.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 1
n=7 Participants
Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 2
n=5 Participants
Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 30 MG: 30mg PO q daily
|
Phase II
Maximum tolerated dose as established in Phase I portion
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
—
|
—
|
58 years
n=4 Participants
|
63 years
n=21 Participants
|
—
|
61 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
—
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
—
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
—
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
—
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
—
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
—
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
—
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
—
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
—
|
12 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: maximum of 18 monthsIn the Phase I portion of the study, a standard 3+3 design will be used to find the maximum tolerated dose.
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
n=12 Participants
Dose Level 1: Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily Dose Level 2: Trametinib 2mg, Ponatinib 30mg
|
Phase I: Dose Level -2
Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 1 MG: 1.0 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -1
Trametinib 1.5 mg PO q daily 15mg PO q daily
Trametinib 1.5 MG: 1.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 1
Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 2
Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 30 MG: 30mg PO q daily
|
Phase II
Maximum tolerated dose as established in Phase I portion
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Ponatinib, Phase I
|
30 mg of ponatinib
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Cardiovascular events were observed at Dose Level 2 and continued exploration of other dose levels did not proceed.
In the Phase II portion of the study, RECIST criteria 1.1 will evaluate the overall response rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase I: Dose Level 1 and Dose Level 2
Dose Level 1: Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily Dose Level 2: Trametinib 2mg, Ponatinib 30mg
|
Phase I: Dose Level -2
Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 1 MG: 1.0 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -1
Trametinib 1.5 mg PO q daily 15mg PO q daily
Trametinib 1.5 MG: 1.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 1
n=7 Participants
Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 2
n=5 Participants
Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 30 MG: 30mg PO q daily
|
Phase II
Maximum tolerated dose as established in Phase I portion
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
|---|---|---|---|---|---|---|
|
Overall Response Rate
Unconfirmed Partial Response
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
|
Overall Response Rate
Stable Disease
|
—
|
—
|
—
|
4 Participants
|
2 Participants
|
—
|
|
Overall Response Rate
Progressive Disease
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
|
Overall Response Rate
Not evaluable
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
—
|
Adverse Events
Phase I: Dose Level -3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I: Dose Level -2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I: Dose Level -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I: Dose Level 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 6 deaths
Phase I: Dose Level 2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Phase II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Dose Level -3
Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily
Trametinib 0.5 mg: 0.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -2
Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 1 MG: 1.0 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -1
Trametinib 1.5 mg PO q daily 15mg PO q daily
Trametinib 1.5 MG: 1.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 1
n=7 participants at risk
Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 2
n=5 participants at risk
Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 30 MG: 30mg PO q daily
|
Phase II
Maximum tolerated dose as established in Phase I portion
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
Other adverse events
| Measure |
Phase I: Dose Level -3
Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily
Trametinib 0.5 mg: 0.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -2
Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 1 MG: 1.0 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level -1
Trametinib 1.5 mg PO q daily 15mg PO q daily
Trametinib 1.5 MG: 1.5mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 1
n=7 participants at risk
Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
Phase I: Dose Level 2
n=5 participants at risk
Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 30 MG: 30mg PO q daily
|
Phase II
Maximum tolerated dose as established in Phase I portion
Trametinib 2 mg: 2 mg PO q daily
Ponatinib 15 MG: 15mg PO q daily
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Nervous system disorders
Headache
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Cardiac disorders
Heart failure
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
General disorders
Non-cardiac chest pain
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Oral hemorrhage
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
General disorders
Pain
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Nervous system disorders
Paresthesia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Platelet count decreased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
42.9%
3/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
71.4%
5/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
57.1%
4/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Skin and subcutaneous tissue disorders
Scalp Sensitivity
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Serum amylase increased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Infections and infestations
Skin infection
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Cardiac disorders
Supraventricular tachycardia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Renal and urinary disorders
Urinary incontinence
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Vascular disorders
Hypertension
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
42.9%
3/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
57.1%
4/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Lipase increased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Infections and infestations
Lung infection
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
42.9%
3/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
General disorders
Malaise
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Infections and infestations
Mucosal infection
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Cardiac disorders
Myocardial infarction
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Weight loss
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
General disorders
Chills
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Cholesterol high
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
42.9%
3/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Eye disorders
Eyelid function disorder
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
General disorders
Fatigue
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
General disorders
Fever
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
42.9%
3/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Creatinine increased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Psychiatric disorders
Delirium
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
42.9%
3/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
60.0%
3/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Dry mouth
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
57.1%
4/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
60.0%
3/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Flatulence
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
General disorders
Edema limbs
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Cardiac disorders
Ejection fraction decreased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Immune system disorders
Allergic reaction
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
28.6%
2/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
40.0%
2/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
20.0%
1/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
14.3%
1/7 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
0.00%
0/5 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
—
0/0 • 2 years
No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms
|
Additional Information
Dr. Kathryn Arbour
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3792
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place