Trial Outcomes & Findings for Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors (NCT NCT05997056)
NCT ID: NCT05997056
Last Updated: 2026-08-25
Results Overview
Objective Response Rate (ORR) is defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks (±7 days) for the first 12 weeks, and every 12 weeks (±7 days) thereafter, up to 22 months.
Results posted on
2026-08-25
Participant Flow
Participants were enrolled from four sites in the United States.
Participant milestones
| Measure |
Neuroendocrine Tumors
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Neuroendocrine Tumors
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Study terminated by sponsor
|
8
|
Baseline Characteristics
Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors
Baseline characteristics by cohort
| Measure |
Neuroendocrine Tumors
n=12 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Age, Customized
Age · <65 years
|
4 Participants
n=31 Participants
|
|
Age, Customized
Age · 65-74 years
|
5 Participants
n=31 Participants
|
|
Age, Customized
Age · > = 75 years
|
3 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks (±7 days) for the first 12 weeks, and every 12 weeks (±7 days) thereafter, up to 22 months.Objective Response Rate (ORR) is defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Neuroendocrine Tumors
n=12 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Percentage of Participants With Objective Response Rate
|
8.3 Percent of participants
Interval 0.2 to 38.5
|
SECONDARY outcome
Timeframe: From first dose of study treatment through end of treatment (estimated up to 18 months) plus safety follow-up of 30 days after the last dose.The percentage of participants experiencing at least one treatment-emergent adverse event (TEAE) and treatment-related adverse event. Adverse events are defined as treatment-emergent (TEAEs) if they began or worsened on or after the first administration of study drug through 28 days after the last administration. Severity of adverse events is graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Outcome measures
| Measure |
Neuroendocrine Tumors
n=12 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events.
|
100 Percent of participants
|
SECONDARY outcome
Timeframe: From first documented response (CR or PR) to radiographically confirmed disease progression (PD) per RECIST v1.1 or death from any cause, assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 monthsDuration of Response (DOR) is determined for patients with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), defined as the time from the scan first showing response by RECIST v1.1 to disease progression (PD) or death from any cause. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Neuroendocrine Tumors
n=1 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Duration of Response (DOR)
|
NA Months
The Duration of Response (DOR) was evaluable in only one subject, and the median could not be estimated due to the absence of events.
|
SECONDARY outcome
Timeframe: From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 monthsDisease Control Rate (DCR) is defined as the proportion of patients achieving a best overall response (BOR) of confirmed complete response (CR), partial response (PR) (either of any duration), or stable disease (SD) lasting \>=12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following study treatment initiation. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Neuroendocrine Tumors
n=12 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Disease Control Rate (DCR)
|
50.0 Percent of participants
Interval 21.1 to 78.9
|
SECONDARY outcome
Timeframe: From the first dose of study treatment to the initial documentation of complete response (CR) or partial response (PR) per RECIST v1.1 , assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 monthsTime to Response (TTR) is defined as the time from the first dose of study medication to the initial measurement of complete response (CR) or partial response (PR), where CR or PR is subsequently confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Neuroendocrine Tumors
n=12 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Time to Response (TTR)
|
1.51 Months
The 95% confidence interval was not estimable due to the limited number of responders (N=1).
|
SECONDARY outcome
Timeframe: From first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed every 6 weeks for the first 12 weeks and every 12 weeks thereafter, up to approximately 21 monthsNumber of months from study treatment initiation to the date of disease progression or death due to any cause
Outcome measures
| Measure |
Neuroendocrine Tumors
n=12 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Progression-free Survival（PFS）
|
10.0 Months
Interval 5.4 to
The upper bound of the confidence interval could not be estimated because the survival curve did not reach the upper threshold due to a limited number of events.
|
SECONDARY outcome
Timeframe: From first dose of study treatment until the date of death from any cause, assessed approximately every 12 weeks following the end-of-treatment visit, up to approximately 24 months.Number of months from study treatment initiation to the date of death due to any cause
Outcome measures
| Measure |
Neuroendocrine Tumors
n=12 Participants
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Overall Survival（OS）
|
NA Months
Interval 9.7 to
The median and the upper limit of the 95% confidence interval were not estimable due to a limited number of events and a high proportion of censored patients.
|
Adverse Events
Neuroendocrine Tumors
Serious events: 4 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Neuroendocrine Tumors
n=12 participants at risk
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Infections and infestations
Coronavirus infection
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
Other adverse events
| Measure |
Neuroendocrine Tumors
n=12 participants at risk
Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
|
|---|---|
|
Gastrointestinal disorders
Stomatitis
|
75.0%
9/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
6/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
4/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Faeces discoloured
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Ascites
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Eructation
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Glossodynia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Haematochezia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Melaena
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
General disorders
Fatigue
|
66.7%
8/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
General disorders
Oedema peripheral
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
General disorders
Chills
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
General disorders
Mucosal inflammation
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
General disorders
Peripheral swelling
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
General disorders
Tenderness
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
6/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
4/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Papule
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Coronavirus infection
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Laryngitis
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Rash pustular
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Infections and infestations
Tooth infection
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
4/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Taste disorder
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Anosmia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Muscle contractions involuntary
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Nervous system disorders
Somnolence
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Investigations
Platelet count decreased
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Investigations
Blood creatinine increased
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Investigations
Weight decreased
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Psychiatric disorders
Libido increased
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Eye disorders
Lacrimation increased
|
25.0%
3/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Eye disorders
Eye irritation
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
16.7%
2/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Renal and urinary disorders
Micturition urgency
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Cardiac disorders
Mitral valve incompetence
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Product Issues
Device malfunction
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place