Trial Outcomes & Findings for Pembrolizumab vs Topotecan in Patients With Small Cell Lung Cancer (NCT NCT02963090)
NCT ID: NCT02963090
Last Updated: 2023-02-15
Results Overview
This phase II study will determine if there is a benefit in progression free survival (PFS) for SCLC patients receiving pembrolizumab (Experimental arm) as compared to topotecan (Control arm) in the second-line settingSCLC patients receiving pembrolizumab (Experimental arm) as compared to topotecan (Control arm) in the second-line setting. RECIST Version 1.1 was used in this study for assessment for tumor response. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, which also includes any lymph node that was normal at baseline (\< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. b. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD. In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
4.2 months
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
Topotecan (Arm A)
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab (Arm B)
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
|---|---|---|
|
Non-cross Over Phase
STARTED
|
3
|
6
|
|
Non-cross Over Phase
COMPLETED
|
2
|
6
|
|
Non-cross Over Phase
NOT COMPLETED
|
1
|
0
|
|
Cross Over Phase
STARTED
|
2
|
0
|
|
Cross Over Phase
COMPLETED
|
2
|
0
|
|
Cross Over Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Topotecan (Arm A)
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab (Arm B)
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
|---|---|---|
|
Non-cross Over Phase
Patient deterioration before starting protocol treatment
|
1
|
0
|
Baseline Characteristics
Pembrolizumab vs Topotecan in Patients With Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Topotecan
n=1 Participants
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab
n=6 Participants
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
Crossover
n=2 Participants
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle. Then at progression of disease by RECIST 1.1. Patients then receive pembrolizumab 200 mg IV every 21-day cycle.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
82 years
n=5 Participants
|
71 years
n=7 Participants
|
63.5 years
n=5 Participants
|
69 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4.2 monthsPopulation: All patients that were treated and evaluated for disease. Crossover patients were analyzed using their time on Arm A.
This phase II study will determine if there is a benefit in progression free survival (PFS) for SCLC patients receiving pembrolizumab (Experimental arm) as compared to topotecan (Control arm) in the second-line settingSCLC patients receiving pembrolizumab (Experimental arm) as compared to topotecan (Control arm) in the second-line setting. RECIST Version 1.1 was used in this study for assessment for tumor response. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, which also includes any lymph node that was normal at baseline (\< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. b. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD. In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.
Outcome measures
| Measure |
Topotecan (Arm A + Crossover Patients)
n=2 Participants
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab
n=6 Participants
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
|---|---|---|
|
Progression Free Survival
|
1.4 Months
Insufficient number of participants with events below the level of detection to determine the lower and upper limits of the Confidence Intervals.
|
1.5 Months
Interval 1.1 to
insufficient number of participants with events below the level of detection to determine the upper limits of the Confidence Intervals
|
SECONDARY outcome
Timeframe: 20 monthsOverall survival will be calculated from the time a patient is registered until the time of death or discontinuation of followup
Outcome measures
| Measure |
Topotecan (Arm A + Crossover Patients)
n=2 Participants
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab
n=6 Participants
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 3.1 to
Not enough events to calculate median or upper limit
|
10.7 Months
Interval 3.6 to
Not enough events to calculate upper limit
|
SECONDARY outcome
Timeframe: 4.2 monthsRECIST Version 1.1\* will be used in this study for assessment for tumor response. Complete Response (CR): All of the following must be true: 1. Disappearance of all target lesions. 2. Each target lymph node must have reduction in short axis to \< 1.0 cm. • Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD
Outcome measures
| Measure |
Topotecan (Arm A + Crossover Patients)
n=2 Participants
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab
n=6 Participants
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
|---|---|---|
|
Overall Response Percentage
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Topotecan
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Pembrolizumab
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Crossover
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Topotecan
n=3 participants at risk
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab
n=6 participants at risk
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
Crossover
n=2 participants at risk
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle. Then at progression of disease by RECIST 1.1. Patients then receive pembrolizumab 200 mg IV every 21-day cycle.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
33.3%
2/6 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
Other adverse events
| Measure |
Topotecan
n=3 participants at risk
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle.
|
Pembrolizumab
n=6 participants at risk
Pembrolizumab IV 200mg infusion Day 1 of every 21 day cycle.
|
Crossover
n=2 participants at risk
Topotecan IV at 1.25 mg/m2 Days 1-5 of every 21 day cycle. Then at progression of disease by RECIST 1.1. Patients then receive pembrolizumab 200 mg IV every 21-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
33.3%
2/6 • Number of events 7 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
33.3%
2/6 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
100.0%
2/2 • Number of events 4 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
100.0%
2/2 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
Weight loss
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
100.0%
2/2 • Number of events 4 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
100.0%
2/2 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
33.3%
2/6 • Number of events 3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
33.3%
2/6 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
33.3%
2/6 • Number of events 5 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
16.7%
1/6 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/2 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
0.00%
0/6 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
50.0%
1/2 • Number of events 1 • 20 months
The crossover arm consists of two of the Arm A patients after they progressed and chose to cross to Arm B treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place