Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer (NCT NCT00802945)
NCT ID: NCT00802945
Last Updated: 2018-07-09
Results Overview
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Up to 2 years.
Results posted on
2018-07-09
Participant Flow
Participant milestones
| Measure |
NKTR-102 14 Day
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
35
|
Reasons for withdrawal
| Measure |
NKTR-102 14 Day
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Overall Study
Death
|
27
|
23
|
|
Overall Study
Terminated by sponsor
|
8
|
12
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
NKTR-102 14 Day
n=35 Participants
NKTR-102
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 Participants
NKTR-102
NKTR-102: NKTR-102 given on a q21 day schedule
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years.Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
NKTR-102 14 Day
n=35 Participants
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 Participants
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Objective Response Rate (ORR)
|
28.6 percentage of subjects
Interval 14.6 to 46.3
|
35 percentage of subjects
Interval 14.6 to 46.3
|
SECONDARY outcome
Timeframe: Up to 2 years.Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
Outcome measures
| Measure |
NKTR-102 14 Day
n=35 Participants
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 Participants
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Kaplan Meier Estimate of Progression-Free Survival (PFS)
|
3.3 Months
Interval 2.6 to 5.7
|
5.6 Months
Interval 1.8 to 6.2
|
SECONDARY outcome
Timeframe: Up to 2 years.OS was calculated as the time from the date of first study drug administration until death from any cause. Subjects alive at the time of analysis were censored at the time they were last known alive. OS was analyzed for the ITT population.
Outcome measures
| Measure |
NKTR-102 14 Day
n=35 Participants
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 Participants
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Kaplan Meier Estimate of Overall Survival (OS)
|
8.8 Months
Interval 5.4 to 15.0
|
13.1 Months
Interval 9.2 to 19.2
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 to the end of 6 months.Six-month survival (i.e., overall survival proportion at 6 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.
Outcome measures
| Measure |
NKTR-102 14 Day
n=35 Participants
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 Participants
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Kaplan Meier Estimate of 6-month Survival
|
57.1 percentage of subjects
Interval 39.3 to 71.5
|
82.9 percentage of subjects
Interval 65.8 to 91.9
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 to the end of 12 months.One year survival (i.e., overall survival proportion at 12 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.
Outcome measures
| Measure |
NKTR-102 14 Day
n=35 Participants
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 Participants
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Kaplan Meier Estimate of 1-year Survival
|
42.9 percentage of subjects
Interval 26.4 to 58.3
|
51.4 percentage of subjects
Interval 34.0 to 66.4
|
SECONDARY outcome
Timeframe: Up to 2 years.An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE was any event not present before exposure to the study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug. All AEs were assessed for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. If a particular AE was not listed in the NCI CTCAE Version 3.0, the following criteria were used: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life threatening or disabling; Grade 5 = Death.
Outcome measures
| Measure |
NKTR-102 14 Day
n=35 Participants
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 Participants
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Percentage of Patient with at Least 1 TEAE
|
68.6 percentage of subjects
|
54.3 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Diarrhoea
|
20.0 percentage of subjects
|
22.9 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Nausea
|
5.7 percentage of subjects
|
2.9 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Fatigue
|
14.3 percentage of subjects
|
8.6 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Vomiting
|
8.6 percentage of subjects
|
5.7 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Decreased appetite
|
2.9 percentage of subjects
|
0 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Abdominal pain
|
2.9 percentage of subjects
|
0 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Dehydration
|
8.6 percentage of subjects
|
11.4 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Neutropenia
|
11.4 percentage of subjects
|
11.4 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Anaemia
|
2.9 percentage of subjects
|
2.9 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Dyspnoea
|
2.9 percentage of subjects
|
0 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Disease progression
|
14.3 percentage of subjects
|
8.6 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Lethargy
|
2.9 percentage of subjects
|
0 percentage of subjects
|
|
Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
Dizziness
|
2.9 percentage of subjects
|
2.9 percentage of subjects
|
Adverse Events
NKTR-102 14 Day
Serious events: 18 serious events
Other events: 35 other events
Deaths: 27 deaths
NKTR-102 21 Days
Serious events: 15 serious events
Other events: 35 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
NKTR-102 14 Day
n=35 participants at risk
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 participants at risk
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Vascular disorders
Lymphoedema
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Disease Progression
|
11.4%
4/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
8.6%
3/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Fatigue
|
5.7%
2/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Pyrexia
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Investigations
ECG Signs Of Myocardial Ischaemia
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Consolidation
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Monoplegia
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Eye disorders
Vision Blurred
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.1%
6/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
11.4%
4/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
2/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
11.4%
4/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Infections and infestations
Pneumonia
|
5.7%
2/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Infections and infestations
Septic Shock
|
2.9%
1/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
0.00%
0/35 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
Other adverse events
| Measure |
NKTR-102 14 Day
n=35 participants at risk
NKTR-102: NKTR-102 given on a q14 day schedule
|
NKTR-102 21 Days
n=35 participants at risk
NKTR-102: NKTR-102 given on a q21 day schedule
|
|---|---|---|
|
Vascular disorders
Hypotension
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • Number of events 1 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Investigations
Weight decreased
|
8.6%
3/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
20.0%
7/35 • Number of events 8 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.1%
6/35 • Number of events 8 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
3/35 • Number of events 5 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • Number of events 1 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.1%
6/35 • Number of events 7 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
5/35 • Number of events 9 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
20.0%
7/35 • Number of events 19 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Dysgeusia
|
8.6%
3/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
11.4%
4/35 • Number of events 5 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Headache
|
11.4%
4/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
11.4%
4/35 • Number of events 5 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Lethargy
|
8.6%
3/35 • Number of events 6 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
14.3%
5/35 • Number of events 6 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Nervous system disorders
Paraesthesia
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • Number of events 1 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Eye disorders
Vision blurred
|
22.9%
8/35 • Number of events 11 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
17.1%
6/35 • Number of events 11 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Asthenia
|
11.4%
4/35 • Number of events 7 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Fatigue
|
42.9%
15/35 • Number of events 55 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
51.4%
18/35 • Number of events 31 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Oedema peripheral
|
11.4%
4/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Pain
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • Number of events 1 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
General disorders
Pyrexia
|
11.4%
4/35 • Number of events 5 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
7/35 • Number of events 9 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
22.9%
8/35 • Number of events 11 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
11.4%
4/35 • Number of events 5 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
14/35 • Number of events 21 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
22.9%
8/35 • Number of events 8 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
68.6%
24/35 • Number of events 58 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
77.1%
27/35 • Number of events 61 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
11.4%
4/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
4/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
68.6%
24/35 • Number of events 33 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
74.3%
26/35 • Number of events 36 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
51.4%
18/35 • Number of events 33 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
40.0%
14/35 • Number of events 18 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
7/35 • Number of events 8 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
11.4%
4/35 • Number of events 5 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
4/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
4/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • Number of events 1 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
14/35 • Number of events 15 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
34.3%
12/35 • Number of events 15 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
17.1%
6/35 • Number of events 6 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
8.6%
3/35 • Number of events 4 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
2/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 2 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
4/35 • Number of events 7 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
3/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
2.9%
1/35 • Number of events 1 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
5.7%
2/35 • Number of events 3 • From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER