Trial Outcomes & Findings for Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases (NCT NCT04610684)
NCT ID: NCT04610684
Last Updated: 2024-03-13
Results Overview
Intracranial PFS is defined as the time from Day 1 of treatment until the criteria for intracranial disease progression is met as defined by RANO-BM or death as a result of any cause, whichever comes first. Progression disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
From C1D1 until death or up to a maximum of 6 months
Results posted on
2024-03-13
Participant Flow
Participant milestones
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
|
|---|---|
|
Study Treatment
STARTED
|
3
|
|
Study Treatment
COMPLETED
|
0
|
|
Study Treatment
NOT COMPLETED
|
3
|
|
Follow up
STARTED
|
3
|
|
Follow up
COMPLETED
|
0
|
|
Follow up
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
|
Study Treatment
Withdrawal by Subject
|
1
|
|
Study Treatment
Disease Progression
|
2
|
|
Follow up
Death
|
2
|
|
Follow up
Withdrawal by Subject
|
1
|
Baseline Characteristics
Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases
Baseline characteristics by cohort
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 Participants
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status (Baseline)
0
|
2 Participants
n=5 Participants
|
|
ECOG Performance Status (Baseline)
1
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From C1D1 until death or up to a maximum of 6 monthsPopulation: This study was terminated early and no analysis was done by the sponsor investigator. Therefore, Intracranial progression free survival status per subject is reported here. If subject progressed per RANO-BM or expired then it is coded as 1, 0 otherwise.
Intracranial PFS is defined as the time from Day 1 of treatment until the criteria for intracranial disease progression is met as defined by RANO-BM or death as a result of any cause, whichever comes first. Progression disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 Participants
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
|
Intracranial Progression Free Survival (iPFS)
Subjects did not progress per RANO-BM
|
1 Participants
|
|
Intracranial Progression Free Survival (iPFS)
Subjects Progressed per RANO-BM
|
2 Participants
|
SECONDARY outcome
Timeframe: From C1D1 until death or up to a maximum of 6 monthsPopulation: This study was terminated early and no analysis was done by the sponsor investigator. Therefore, overall response rate status per subject is reported here. If subject recorded any PR/CR per RECIST 1.1 then it is coded as 1, 0 otherwise.
ORR will include complete response (CR) + partial response (PR) as determined by RECIST 1.1. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 Participants
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
|
Overall Response Rate (ORR)
Responder
|
1 Participants
|
|
Overall Response Rate (ORR)
Non-Responder
|
02 Participants
|
SECONDARY outcome
Timeframe: From C1D1 until death or up to a maximum of 6 monthsPopulation: This study was terminated early and no analysis was done by the sponsor investigator. Therefore, extracranial progression free survival status per subject is reported here. If subject progressed per RECIST 1.1 or expired then it is coded as 1, 0 otherwise.
Extracranial PFS is defined as the time from Day 1 of treatment until the criteria for extracranial disease progression is met as defined by RECIST 1.1 or death as a result of any cause, whichever comes first.Progression disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 Participants
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
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Extracranial Progression Free Survival (PFS)
PFS 0 per RECIST 1.1
|
2 Participants
|
|
Extracranial Progression Free Survival (PFS)
PFS 1 per RECIST 1.1
|
1 Participants
|
SECONDARY outcome
Timeframe: From C1D1 until death or up to a maximum of 9 monthsPopulation: This study was terminated early and no analysis was done by the sponsor investigator. Therefore, overall survival status per subject is reported here. If subject expired then it is coded as 1, 0 otherwise.
OS is defined as the time from Day 1 of treatment until death as a result of any cause.
Outcome measures
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 Participants
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
|
Overall Survival (OS)
Subjects Expired
|
2 Participants
|
|
Overall Survival (OS)
Subjects Not Expired
|
1 Participants
|
SECONDARY outcome
Timeframe: From C1D1 until death or up to a maximum of 9 monthsPopulation: This study was terminated early and no analysis was done by the sponsor investigator.
Toxicity of atezolizumab has been evaluated when administered with carboplatin and etoposide in subjects with untreated SCLC brain metastases.Toxicity will be graded by Common Toxicity Criteria for Adverse Events (CTCAE V5).
Outcome measures
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 Participants
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
|
Toxicity of Atezolizumab Plus Carboplatin and Etoposide
Number of patients had at least one adverse event of any grade
|
3 Participants
|
|
Toxicity of Atezolizumab Plus Carboplatin and Etoposide
Number of patients had at least one toxicity grade 3 or greater adverse event
|
3 Participants
|
|
Toxicity of Atezolizumab Plus Carboplatin and Etoposide
Number of patients had at least one grade 3 or greater treatment related adverse event
|
2 Participants
|
|
Toxicity of Atezolizumab Plus Carboplatin and Etoposide
Number of patients having serious adverse event
|
1 Participants
|
Adverse Events
Arm 1 : Carboplatin + Etoposide + Atezolizumab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 participants at risk
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
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Infections and infestations
LUNG INFECTION
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
Other adverse events
| Measure |
Arm 1 : Carboplatin + Etoposide + Atezolizumab
n=3 participants at risk
4 cycles of induction treatment with Atezolizumab (1200 mg on Day 1) combined with carboplatin (5-6 AUC on Day 1) and etoposide (80-100 mg/m2 on Days 1-3). After 4 cycles of induction treatment, subjects will receive atezolizumab maintenance 1200 mg on Day 1 of each 3-week cycle.
Carboplatin: Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
Etoposide: Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
Atezolizumab: Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
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|---|---|
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Gastrointestinal disorders
ABDOMINAL DISTENSION
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
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Investigations
ALKALINE PHOSPHATASE INCREASED
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
100.0%
3/3 • Number of events 4 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Blood and lymphatic system disorders
ANEMIA
|
66.7%
2/3 • Number of events 5 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Psychiatric disorders
ANXIETY
|
100.0%
3/3 • Number of events 3 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
66.7%
2/3 • Number of events 3 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Psychiatric disorders
DEPRESSION
|
33.3%
1/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Gastrointestinal disorders
DIARRHEA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Nervous system disorders
DYSGEUSIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
66.7%
2/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Renal and urinary disorders
DYSURIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
General disorders
EDEMA LIMBS
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
General disorders
EDEMA TRUNK
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
General disorders
FATIGUE
|
100.0%
3/3 • Number of events 3 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
33.3%
1/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Nervous system disorders
HEADACHE
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Renal and urinary disorders
HEMATURIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Metabolism and nutrition disorders
HYPERLIPIDEMIA
|
33.3%
1/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Vascular disorders
HYPERTENSION
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
66.7%
2/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
33.3%
1/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Psychiatric disorders
INSOMNIA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Infections and infestations
LUNG INFECTION
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
66.7%
2/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Gastrointestinal disorders
NAUSEA
|
66.7%
2/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Metabolism and nutrition disorders
OBESITY
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
General disorders
PAIN
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Nervous system disorders
TREMOR
|
33.3%
1/3 • Number of events 1 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR PAIN
|
33.3%
1/3 • Number of events 2 • From C1D1 until death or up to a maximum of 9 months
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment or until the start of a new anti-cancer treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place