Not provided
Not provided
Not provided
Not provided
Not provided
The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.
This study is a phase 4 study, to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China, and only collect the safety data.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | Crizotinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | receive crizotinib orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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) |
| 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 | 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. | 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Province Oncology Hospital | Fuzhou | Fujian | 350014 | China | ||
| The First Affiliated Hospital of Guangzhou Medical University |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) included all participants who had been enrolled in the study, regardless of whether treatment was received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Crizotinib | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Safety analysis set included all participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crizotinib | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2019 | Sep 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2019 | Sep 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
Not provided
Not provided
single arm, open label study.
Not provided
Not provided
Not provided
Not provided
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| The First Affiliated Hospital of Guangzhou Medical University | Liwan District,Guangzhou | Guangdong | 510145 | China |
| Eastern Theater General Hospital ,QinHuai District Medical Area | Nanjing | Jiangsu | 210002 | China |
| Jilin Province Cancer Hospital | Changchun | Jilin | 130000 | China |
| Jilin Provincial Cancer Hospital | Changchun | Jilin | 130012 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| Sichuan Province Cancer Hospital/Department of Pulmonary Tumor | Chengdu | Sichuan | 610041 | China |
| Sichuan Province Cancer Hospital | Chengdu | Sichuan | 610041 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Beijing Cancer Hospital, Internal Department | Beijing | 100142 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Progressive disease |
|
| Global deterioration of health status |
|
| Refused further treatment |
|
| Rolled over to a continuous study for Crizotinib treatment |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | 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 | 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. | Safety analysis set included all participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
|
|
|
| 3 |
| 41 |
| 13 |
| 41 |
| 8 |
| 41 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v26.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
|
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.
| D011725 |
| Pyridines |
| Title | Measurements |
|---|---|
|
| Treatment Related SAEs |
|