Trial Outcomes & Findings for A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer (NCT NCT01326871)
NCT ID: NCT01326871
Last Updated: 2024-06-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
68 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-06-25
Participant Flow
Phase 1b and Phase 2 subjects were combined by ALT-801 dose level and whether they received cisplatin or did not.
Participant milestones
| Measure |
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
49
|
16
|
|
Overall Study
COMPLETED
|
3
|
21
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
28
|
15
|
Reasons for withdrawal
| Measure |
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
|---|---|---|---|
|
Overall Study
Major surgery
|
0
|
1
|
0
|
|
Overall Study
SAE and death
|
0
|
2
|
0
|
|
Overall Study
Physician decision and decreased performance status
|
0
|
1
|
0
|
|
Overall Study
Disease progression
|
0
|
11
|
5
|
|
Overall Study
Did not qualify or consent for repeat treatment
|
0
|
1
|
0
|
|
Overall Study
Subject decision to continue survival follow-up only
|
0
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
DLT
|
0
|
2
|
0
|
|
Overall Study
SAE, disease progression and subject decision
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
3
|
0
|
|
Overall Study
SAE and disease progression
|
0
|
0
|
1
|
|
Overall Study
SAE and physician decision
|
0
|
0
|
1
|
|
Overall Study
Did not qualify/consent for repeat treatment, subject decision to continue survival follow-up only
|
0
|
0
|
1
|
|
Overall Study
Did not qualify or consent for repeat treatment and disease progression
|
0
|
0
|
1
|
|
Overall Study
Physician decision, AEs and subject compliance
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
SAE
|
0
|
0
|
1
|
|
Overall Study
Disease progression and death
|
0
|
0
|
1
|
|
Overall Study
Subject decision
|
0
|
0
|
1
|
Baseline Characteristics
A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
Baseline characteristics by cohort
| Measure |
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
n=3 Participants
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
n=49 Participants
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
n=16 Participants
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
63 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
65 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
63 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Subjects with Muscle Invasive or Metastatic Urothelial Cancer
|
3 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
ALT-801: 0.04 mg/kg, 0.06 mg/kg
n=9 Participants
Recommended dose is ALT-801 0.06 mg/kg
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) and/or the Recommended Dose (RD) for Dose Expansion of ALT-801 in Combination With Cisplatin and Gemcitabine or ALT-801 in Combination With Gemcitabine Alone
|
0.06 mg/kg Recommended Dose
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 weeksNumber of AEs that occur or worsen after the first dose of study treatment
Outcome measures
| Measure |
ALT-801: 0.04 mg/kg, 0.06 mg/kg
n=3 Participants
Recommended dose is ALT-801 0.06 mg/kg
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
n=49 Participants
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
n=16 Participants
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
49 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent to treat population
Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \[RECIST V1.0\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Outcome measures
| Measure |
ALT-801: 0.04 mg/kg, 0.06 mg/kg
n=3 Participants
Recommended dose is ALT-801 0.06 mg/kg
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
n=49 Participants
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
n=16 Participants
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
|---|---|---|---|
|
Objective Response Rate in Treated Patients
|
100 percentage of participants
Interval 29.0 to 100.0
|
47 percentage of participants
Interval 33.0 to 62.0
|
6 percentage of participants
Interval 0.0 to 30.0
|
Adverse Events
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
Serious events: 20 serious events
Other events: 49 other events
Deaths: 42 deaths
ALT-801 0.06 mg/kg With Gemcitabine
Serious events: 8 serious events
Other events: 16 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
n=3 participants at risk
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
n=49 participants at risk
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
n=16 participants at risk
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
4.1%
2/49
|
6.2%
1/16
|
|
General disorders
Death
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
6.1%
3/49
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
4.1%
2/49
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
6.1%
3/49
|
0.00%
0/16
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Vascular disorders
Embolism
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Nervous system disorders
Seizure
|
0.00%
0/3
|
2.0%
1/49
|
0.00%
0/16
|
Other adverse events
| Measure |
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
n=3 participants at risk
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
n=49 participants at risk
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
ALT-801 0.06 mg/kg With Gemcitabine
n=16 participants at risk
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
|
|---|---|---|---|
|
General disorders
Fatigue
|
66.7%
2/3
|
73.5%
36/49
|
31.2%
5/16
|
|
General disorders
Chills
|
33.3%
1/3
|
49.0%
24/49
|
43.8%
7/16
|
|
General disorders
Pyrexia
|
66.7%
2/3
|
46.9%
23/49
|
31.2%
5/16
|
|
General disorders
Oedema peripheral
|
33.3%
1/3
|
30.6%
15/49
|
6.2%
1/16
|
|
General disorders
Pain
|
33.3%
1/3
|
14.3%
7/49
|
6.2%
1/16
|
|
General disorders
Influenza like illness
|
33.3%
1/3
|
6.1%
3/49
|
6.2%
1/16
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3
|
79.6%
39/49
|
50.0%
8/16
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3
|
59.2%
29/49
|
37.5%
6/16
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3
|
38.8%
19/49
|
31.2%
5/16
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
38.8%
19/49
|
25.0%
4/16
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
14.3%
7/49
|
12.5%
2/16
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
16.3%
8/49
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
10.2%
5/49
|
6.2%
1/16
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3
|
6.1%
3/49
|
0.00%
0/16
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
4.1%
2/49
|
6.2%
1/16
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Investigations
Platelet count decreased
|
100.0%
3/3
|
85.7%
42/49
|
56.2%
9/16
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3
|
57.1%
28/49
|
12.5%
2/16
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3
|
34.7%
17/49
|
31.2%
5/16
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
38.8%
19/49
|
25.0%
4/16
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3
|
30.6%
15/49
|
37.5%
6/16
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3
|
22.4%
11/49
|
31.2%
5/16
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3
|
22.4%
11/49
|
25.0%
4/16
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3
|
22.4%
11/49
|
18.8%
3/16
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
12.2%
6/49
|
6.2%
1/16
|
|
Investigations
Weight increased
|
33.3%
1/3
|
6.1%
3/49
|
6.2%
1/16
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3
|
4.1%
2/49
|
12.5%
2/16
|
|
Investigations
International normalised ration increased
|
0.00%
0/3
|
4.1%
2/49
|
6.2%
1/16
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3
|
53.1%
26/49
|
25.0%
4/16
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3
|
40.8%
20/49
|
37.5%
6/16
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3
|
30.6%
15/49
|
37.5%
6/16
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3
|
30.6%
15/49
|
37.5%
6/16
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
40.8%
20/49
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
26.5%
13/49
|
18.8%
3/16
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3
|
22.4%
11/49
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
24.5%
12/49
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
16.3%
8/49
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
10.2%
5/49
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3
|
4.1%
2/49
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3
|
61.2%
30/49
|
56.2%
9/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
3/3
|
34.7%
17/49
|
37.5%
6/16
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
3/3
|
36.7%
18/49
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3
|
10.2%
5/49
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3
|
8.2%
4/49
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3
|
8.2%
4/49
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
36.7%
18/49
|
25.0%
4/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3
|
24.5%
12/49
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
14.3%
7/49
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3
|
10.2%
5/49
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
33.3%
1/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Acute promyelocytic leukaemia differentiation syndrome
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
33.3%
1/3
|
16.3%
8/49
|
6.2%
1/16
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3
|
16.3%
8/49
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
12.2%
6/49
|
6.2%
1/16
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
8.2%
4/49
|
0.00%
0/16
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
6.1%
3/49
|
0.00%
0/16
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Vascular disorders
Hypotension
|
33.3%
1/3
|
18.4%
9/49
|
43.8%
7/16
|
|
Vascular disorders
Embolism
|
0.00%
0/3
|
12.2%
6/49
|
12.5%
2/16
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
6.1%
3/49
|
6.2%
1/16
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3
|
4.1%
2/49
|
6.2%
1/16
|
|
Vascular disorders
Hot flush
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
20.4%
10/49
|
25.0%
4/16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
10.2%
5/49
|
18.8%
3/16
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
|
8.2%
4/49
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
8.2%
4/49
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
10.2%
5/49
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
10.2%
5/49
|
12.5%
2/16
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3
|
4.1%
2/49
|
6.2%
1/16
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
6.1%
3/49
|
0.00%
0/16
|
|
Infections and infestations
Skin infection
|
33.3%
1/3
|
4.1%
2/49
|
0.00%
0/16
|
|
Infections and infestations
Cystitis
|
33.3%
1/3
|
2.0%
1/49
|
0.00%
0/16
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Infections and infestations
Eye infection
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Infections and infestations
Root canal infection
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3
|
12.2%
6/49
|
0.00%
0/16
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3
|
6.1%
3/49
|
18.8%
3/16
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
8.2%
4/49
|
12.5%
2/16
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3
|
8.2%
4/49
|
0.00%
0/16
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
14.3%
7/49
|
12.5%
2/16
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
8.2%
4/49
|
18.8%
3/16
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
6.1%
3/49
|
18.8%
3/16
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3
|
10.2%
5/49
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3
|
0.00%
0/49
|
0.00%
0/16
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
8.2%
4/49
|
18.8%
3/16
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3
|
4.1%
2/49
|
12.5%
2/16
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3
|
6.1%
3/49
|
0.00%
0/16
|
|
Eye disorders
Vision blurred
|
33.3%
1/3
|
2.0%
1/49
|
6.2%
1/16
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3
|
0.00%
0/49
|
6.2%
1/16
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3
|
8.2%
4/49
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place