Trial Outcomes & Findings for A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer (NCT NCT01625260)
NCT ID: NCT01625260
Last Updated: 2024-07-19
Results Overview
Confirmation of the safety and tolerability (dose limiting toxicity count) of ALT-801 combined with gemcitabine.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-07-19
Participant Flow
Only Phase 1B was enrolled, no subjects were enrolled in Phase 2.
Participant milestones
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Study Terminated by Investigator
|
2
|
0
|
|
Overall Study
Disease Progression
|
2
|
0
|
|
Overall Study
PI and subject decided to terminate treatment
|
0
|
1
|
Baseline Characteristics
A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=9 Participants
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 Participants
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 4.36 • n=7 Participants
|
65.1 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Patients with Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksConfirmation of the safety and tolerability (dose limiting toxicity count) of ALT-801 combined with gemcitabine.
Outcome measures
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=9 Participants
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 Participants
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Safety Profile
|
2 Number of DLTs
|
1 Number of DLTs
|
PRIMARY outcome
Timeframe: From start of study treatment to up to 13 weeksPopulation: The population only included patients evaluable for response. 2 participants had no disease response information provided.
The response rate was calculated as the ratio of the number of patients who demonstrated a complete response (by RECIST v1.1) divided by the number of patients evaluable for response. A complete response was defined as having negative bladder biopsy results.
Outcome measures
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=7 Participants
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 Participants
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Disease Response Rate
|
43 percentage of participants
Interval 9.9 to 81.6
|
67 percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: From confirmed complete response to up to 3 yearsPopulation: Subjects with complete response
Duration of response was defined as the time from the date of first complete response (by RECIST v1.1) to the date of disease progression (by RECIST v1.1) or death (from any cause), whichever occured first. A complete response was defined as having negative bladder biopsy results. Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 Participants
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=2 Participants
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Duration of Response
|
NA Months
Interval 5.2 to
NA = not calculable due to small number of complete responders
|
2.1 Months
Interval 1.2 to
NA = not calculable due to small number of complete responders
|
SECONDARY outcome
Timeframe: From start of study treatment to up to 3 yearsPopulation: The population only included patients evaluable for response. 2 participants had no disease response information provided.
The progression-free survival was defined as the time from the start of study treatment to first documentation of objective tumor progression or disease recurrence (by RECIST v1.1). Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=7 Participants
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 Participants
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Progression-free Survival
|
3.4 Months
Interval 1.7 to
not calculable due to small sample size and small number of subjects with events
|
2.9 Months
Interval 2.7 to
not calculable due to small sample size and small number of subjects with events
|
SECONDARY outcome
Timeframe: From start of study treatment to up to 3 yearsPopulation: The population only included patients evaluable for response. 2 participants had no disease response information provided.
The event-free survival was defined as the time from the start of study treatment to first documentation of objective tumor progression (by RECIST v1.1), disease recurrence, bladder resection or irradiation, other anti-bladder cancer therapy, or to death due to any cause, which ever came first. Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=7 Participants
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 Participants
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Event-free Survival
|
3.4 Months
Interval 1.7 to
not calculable due to small sample size and small number of subjects with events
|
2.9 Months
Interval 2.7 to
not calculable due to small sample size and small number of subjects with events
|
SECONDARY outcome
Timeframe: From start of study treatment to up to 3 yearsOS was defined as the time from start of study treatment to death resulting from any cause.
Outcome measures
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=9 Participants
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 Participants
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Overall Survival
|
NA Months
Interval 7.5 to
not calculable due to small sample size and small number of subjects with events
|
NA Months
Interval 21.2 to
not calculable due to small sample size and small number of subjects with events
|
Adverse Events
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
Serious events: 3 serious events
Other events: 9 other events
Deaths: 2 deaths
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=9 participants at risk
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 participants at risk
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
Infections and infestations
Skin Infection
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Immune system disorders
Anaphylaxis
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
Other adverse events
| Measure |
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=9 participants at risk
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine
n=3 participants at risk
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
|
|---|---|---|
|
General disorders
Chills
|
77.8%
7/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
66.7%
2/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
Fatigue
|
66.7%
6/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
66.7%
2/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
Edema limbs
|
44.4%
4/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
66.7%
2/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
Fever
|
33.3%
3/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
66.7%
2/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
Dry skin
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
Flu like symptoms
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
Gait disturbance
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
General disorders and administration site conditions-other, feeling cold
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
General disorders
General disorders and administration site conditions-other, upper lip swelling
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
100.0%
3/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash mucula-papular
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash on thigh, back and buttocks
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-other, gritty, sandpaper feeling between fingers
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-other, hand-foot skin reaction
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
44.4%
4/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
3/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Neutrophil count decreased
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Lymphocyte count decreased
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Platelet count decreased
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Alannine aminotransferase increased
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Asparte aminotransferase increased
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
Weight gain
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
100.0%
3/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Nervous system disorders
Nervous system disorders, other-numbness
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Nervous system disorders
Tremors
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Vascular disorders
Hypotension
|
33.3%
3/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
66.7%
2/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Vascular disorders
Hot flashes
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
3/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non specific)
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Psychiatric disorders
Anxiety
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Psychiatric disorders
Restlessness
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
66.7%
2/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty swallowing
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Infections and infestations
Skin infection
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Renal and urinary disorders
Acute kidney disease
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Renal and urinary disorders
Hematuria
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Renal and urinary disorders
Renal and urinary disorders, other-pyuria
|
0.00%
0/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Eye disorders
Eye disorders-other, visual disturbances
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Hepatobiliary disorders
Elevated alanine aminotransferase
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Hepatobiliary disorders
Elevated Aspartate aminotransferase
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Hepatobiliary disorders
Increased bilirubin
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Immune system disorders
Anaphylaxis
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
0.00%
0/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
33.3%
1/3 • For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place