Trial Outcomes & Findings for Long Term Safety Observation of Crizotinib in Chinese NSCLC Population (NCT NCT03672643)
NCT ID: NCT03672643
Last Updated: 2024-11-08
Results Overview
An AE was any untoward medical occurrence in a clinical study participant associated with the use of study intervention, whether or not considered related to the study intervention. According to NCI CTCAE version 4.03: Grade 3 indicates severe AE, Grade 4 indicates life-threatening consequences and urgent intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Results posted on
2024-11-08
Participant Flow
A total of 41 Chinese participants who were previously recruited in Pfizer-sponsored Crizotinib studies (A8081005 \[NCT00932451\], A8081014 \[NCT01154140\], A8081029 \[NCT01639001\], A8081063 \[NCT01945021\]) were enrolled in the current study to continue treatment with Crizotinib.
Participant milestones
| Measure |
Crizotinib
Participants received Crizotinib 250 milligrams (mg) orally twice daily (BID) administered in treatment cycle of 28 days until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first.
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|---|---|
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Overall Study
STARTED
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41
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|
Overall Study
COMPLETED
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0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Crizotinib
Participants received Crizotinib 250 milligrams (mg) orally twice daily (BID) administered in treatment cycle of 28 days until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first.
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|---|---|
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Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progressive disease
|
11
|
|
Overall Study
Global deterioration of health status
|
1
|
|
Overall Study
Refused further treatment
|
7
|
|
Overall Study
Rolled over to a continuous study for Crizotinib treatment
|
16
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Baseline Characteristics
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
Baseline characteristics by cohort
| Measure |
Crizotinib
n=41 Participants
Participants received Crizotinib 250 mg orally BID administered in treatment cycle of 28 days until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first.
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|---|---|
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Age, Continuous
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58.0 Years
STANDARD_DEVIATION 12.14 • n=99 Participants
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|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
41 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)Population: Safety analysis set included all participants who received at least one dose of the study treatment.
An AE was any untoward medical occurrence in a clinical study participant associated with the use of study intervention, whether or not considered related to the study intervention. According to NCI CTCAE version 4.03: Grade 3 indicates severe AE, Grade 4 indicates life-threatening consequences and urgent intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event.
Outcome measures
| Measure |
Crizotinib
n=41 Participants
Participants received Crizotinib 250 mg orally BID administered in treatment cycle of 28 days until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first.
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|---|---|
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Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
Grade 3 or 4 AEs
|
19 Participants
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|
Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
Grade 5 AEs
|
2 Participants
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|
Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
AEs Leading to Treatment Discontinuation
|
4 Participants
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|
Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
SAEs
|
13 Participants
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PRIMARY outcome
Timeframe: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)Population: Safety analysis set included all participants who received at least one dose of the study treatment.
An AE was any untoward medical occurrence in a clinical study participant associated with use of study intervention, whether or not considered related to study intervention. AEs that were related to treatment were evaluated in this outcome measure. Treatment relatedness was judged by investigator. According to NCI CTCAE version 4.03: Grade 3= severe AE, Grade 4= life-threatening consequences and urgent intervention indicated, Grade 5= death related to AE. Participants who discontinued treatment due to treatment related AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event.
Outcome measures
| Measure |
Crizotinib
n=41 Participants
Participants received Crizotinib 250 mg orally BID administered in treatment cycle of 28 days until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first.
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|---|---|
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Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03
Treatment Related Grade 3 or 4 AEs
|
11 Participants
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|
Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03
Treatment Related Grade 5 AEs
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03
Treatment Related AEs Leading to Treatment Discontinuation
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03
Treatment Related SAEs
|
4 Participants
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Adverse Events
Crizotinib
Serious events: 13 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Crizotinib
n=41 participants at risk
Participants received Crizotinib 250 mg orally BID administered in treatment cycle of 28 days until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first.
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|---|---|
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Gastrointestinal disorders
Crohn's disease
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
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2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Impaired gastric emptying
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2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Obstruction gastric
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2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Disease progression
|
4.9%
2/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Anal abscess
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2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Herpes zoster
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Postoperative wound infection
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Pyelonephritis chronic
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Cerebral infarction
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Pregnancy, puerperium and perinatal conditions
Biochemical pregnancy
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Vascular disorders
Thrombosis
|
2.4%
1/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
Other adverse events
| Measure |
Crizotinib
n=41 participants at risk
Participants received Crizotinib 250 mg orally BID administered in treatment cycle of 28 days until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first.
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|---|---|
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Investigations
Neutrophil count decreased
|
19.5%
8/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
White blood cell count decreased
|
7.3%
3/41 • From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER