Trial Outcomes & Findings for Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours (NCT NCT03620643)
NCT ID: NCT03620643
Last Updated: 2025-10-30
Results Overview
To assess confirmed response rate by RECIST 1.1 of crizotinib and fulvestrant in advanced E-cadherin negative, ER positive lobular breast cancer.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
From Day 1 to Progressive Disease, assessed up to end of study (Approximately 57 months)
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Crizotinib Oral Capsule [Xalkori] Monotherapy
Arm 1 basket (diffuse gastric cancer, triple negative lobular breast cancer and Other CDH1 mutated cancer) cohort
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
Arm 2 ER positive lobular breast cancer cohort
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
27
|
|
Overall Study
COMPLETED
|
6
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Crizotinib Oral Capsule [Xalkori] Monotherapy
n=6 Participants
Arm 1 - Basket (diffuse gastric cancer, triple negative lobular breast cancer and Other CDH1 mutated cancer) cohort."
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=27 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=6 Participants
|
21 Participants
n=27 Participants
|
24 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=6 Participants
|
6 Participants
n=27 Participants
|
9 Participants
n=33 Participants
|
|
Age, Continuous
|
63 years
n=6 Participants
|
57 years
n=27 Participants
|
57 years
n=33 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
27 Participants
n=27 Participants
|
33 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=6 Participants
|
27 participants
n=27 Participants
|
33 participants
n=33 Participants
|
|
Menopausal Status
Peri-menopausal
|
1 Participants
n=6 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=33 Participants
|
|
Menopausal Status
Post-menopausal
|
4 Participants
n=6 Participants
|
20 Participants
n=27 Participants
|
24 Participants
n=33 Participants
|
|
Menopausal Status
Pre-menopausal
|
1 Participants
n=6 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=33 Participants
|
|
Cancer
ER positive/HER2 negative Lobular breast cancer
|
0 Participants
n=6 Participants
|
27 Participants
n=27 Participants
|
27 Participants
n=33 Participants
|
|
Cancer
Diffuse gastric cancer
|
1 Participants
n=6 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=33 Participants
|
|
Cancer
Triple negative lobular breast cancer
|
5 Participants
n=6 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=33 Participants
|
|
Cancer
other CDH1 Mutated cancer
|
0 Participants
n=6 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Progressive Disease, assessed up to end of study (Approximately 57 months)Population: Patients who receive at least one cycle of the trial medication and had at least one response (RECIST 1.1 scan) post treatment start. Patients who stopped study treatment before the first response evaluation scan has been performed with clinical progression were included in the disease progression category.
To assess confirmed response rate by RECIST 1.1 of crizotinib and fulvestrant in advanced E-cadherin negative, ER positive lobular breast cancer.
Outcome measures
| Measure |
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=27 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
Arm 2 - ER positive lobular breast cancer cohort
|
|---|---|---|
|
Percentage of Breast Cancer Cohort Participants With Confirmed Response Assessed Using RECIST v1.1
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Progressive Disease, assessed up to end of study (Approximately 57 months)Population: Patients who received at least one cycle of the trial medication and had at least one response (RECIST 1.1 scan) post treatment start. Patients who stopped study treatment before the first response evaluation scan has been performed with clinical progression were included in the disease progression category.
To assess confirmed response rate (CR/PR outcome) by RECIST 1.1 scan of crizotinib monotherapy in advanced E-cadherin negative, diffuse gastric cancer, triple negative lobular breast cancer or CDH1-mutated solid tumour.
Outcome measures
| Measure |
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=3 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
Arm 2 - ER positive lobular breast cancer cohort
|
|---|---|---|
|
Percentage of Basket Cohort Participants With Confirmed Response Assessed Using RECIST v1.1
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to 30 days after last dose of study drug, assessed up to end of study (Approximately 57 months)Population: Intention to treat (ITT) analysis population.
To assess the overall safety and tolerability of crizotinib with fulvestrant in the breast cancer cohort and as monotherapy in the basket cancer cohort. Toxicity will be assessed by CTCAE (version 4) every 4 weeks during study treatment. Adverse events, including serious adverse events, will be recorded until 30 days after the last dose of study treatment with crizotinib.
Outcome measures
| Measure |
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=6 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=27 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
|
6 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (Approximately 57 months)Population: Intention to treat (ITT) analysis population.
PFS is defined as the time from baseline treatment to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=6 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=27 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
|---|---|---|
|
Progression-free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Both Basket and Breast Cancer Cohorts
|
1.8 months
Interval 0.5 to
The upper boundary of the 95% confidence interval of the PFS not estimable due to small number of subjects recruitment and events observed.
|
1.8 months
Interval 1.1 to 3.2
|
SECONDARY outcome
Timeframe: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (Approximately 57 months)Overall survival, calculated from day 1 of study treatment to the date of death from any cause.
Outcome measures
| Measure |
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=6 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=27 Participants
Arm 2 - ER positive lobular breast cancer cohort
|
|---|---|---|
|
Assessment of Overall Survival in Each Cohort
|
4.4 months
Interval 1.3 to
The upper boundary of the 95% confidence interval of the OS not estimable due to the small number of subjects recruitment and events observed.
|
17.5 months
Interval 6.9 to 26.0
|
Adverse Events
Crizotinib Oral Capsule [Xalkori] Monotherapy
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
Serious events: 5 serious events
Other events: 27 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Crizotinib Oral Capsule [Xalkori] Monotherapy
n=6 participants at risk
Arm 1 - Basket (diffuse gastric cancer, triple negative lobular breast cancer and Other CDH1 mutated cancer) cohort.
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=27 participants at risk
Arm 2 - ER positive lobular breast cancer
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Gastric Ulcer
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
3.7%
1/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
3.7%
1/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Fever
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
3.7%
1/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
Other adverse events
| Measure |
Crizotinib Oral Capsule [Xalkori] Monotherapy
n=6 participants at risk
Arm 1 - Basket (diffuse gastric cancer, triple negative lobular breast cancer and Other CDH1 mutated cancer) cohort.
|
Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection
n=27 participants at risk
Arm 2 - ER positive lobular breast cancer
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
66.7%
4/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
63.0%
17/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
74.1%
20/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
29.6%
8/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
37.0%
10/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
59.3%
16/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Edema trunk
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
14.8%
4/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
14.8%
4/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
14.8%
4/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
44.4%
12/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Eye disorders
Flashing lights
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
14.8%
4/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
48.1%
13/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
74.1%
20/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Obstruction gastric
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Edema limbs
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Fatigue
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
44.4%
12/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Pain
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
33.3%
9/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
18.5%
5/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
0.00%
0/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Blood and lymphatic system disorders
Other
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
29.6%
8/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
GGT increased
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
22.2%
6/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
22.2%
6/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
22.2%
6/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
18.5%
5/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
18.5%
5/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
14.8%
4/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Fever
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Localized edema
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Eye disorders
Other
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
14.8%
4/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Gastrointestinal disorders
Other
|
33.3%
2/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
General disorders
Other
|
50.0%
3/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
25.9%
7/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Infections and infestations
Other
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Investigations
Other
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
22.2%
6/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Musculoskeletal and connective tissue disorders
Other
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Nervous system disorders
Other
|
0.00%
0/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
7.4%
2/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
14.8%
4/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
|
Skin and subcutaneous tissue disorders
Other
|
16.7%
1/6 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
11.1%
3/27 • For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
|
Additional Information
Clinical Trial Manager
The Royal Marsden NHS Foundation Trust
Phone: 02078082887
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place