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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022978-14 | EudraCT Number |
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Termination of further treatment on the study due to the availability of commercial supply or a rollover study (NCT05160922) that will allow active subjects to continue receiving treatment.
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This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crizotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care activity of daily living (ADL); Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks) |
| Number of Participants With All-Causality TEAEs in the Pediatric Population | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication.Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks) |
| Number of Participants With Treatment-Related TEAEs | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Based on Investigator Assessement | PFS was defined as the time from the date of first dose of study medication to the date of the first documentation of objective tumor progression (at least a 20% increase in the sum of 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. The appearance of one or more new lesions is also considered a sign of progression) or death on treatment due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. The median PFS was estimated using Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Highlands Oncology Group |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 44 Anaplastic lymphoma kinase (ALK) genetic event positive participants were enrolled into the study and treated: 17 with anaplastic large cell lymphoma (ALCL), 9 with inflammatory myofibroblastic tumors (IMT), and 18 with other tumors (ALK-positive malignancies excluding non-small cell lung cancer).
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| ID | Title | Description |
|---|---|---|
| FG000 | ALCL Arm | In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2015 | Apr 2, 2024 |
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| From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks) |
| Number of Participants With Treatment-Related TEAEs in the Pediatric Population | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks) |
| Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries) | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and clinical chemistry parameters were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks) |
| Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries) in the Pediatric Population | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and chemistry laboratory assessments were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Unplanned laboratory test results were also included. | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks) |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response | Percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) as determined by the investigators. CR = disappearance of all target lesions. PR = greater than equal to (>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. ORR based on Cheson criteria was defined similarly however, confirmation of response was not required. If participant had tumor response assessed only by RECIST or Cheson, then ORR was based on the single result. If tumor response was assessed by both RECIST and Cheson, then ORR was reported based on tumor response by Cheson criteria unless the Cheson has indeterminate result, in which case the RECIST result was reported. Participant(s) who did not have tumor assessment results from either RECIST 1.1 or Cheson criteria reported at baseline were to be excluded from the analysis. | From the date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occured first (maximum 374 weeks) |
| From the date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occurs first (maximum 444 weeks) |
| Duration of Response (DR) Based on Investigator Assessement | DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. CR: disappearance of all lesions; any pathological lymph nodes (target lesions [TLs]) or non-target lesions (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; PR: >=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters; DR (in weeks) was calculated as (first date of PD or death - first date of CR or PR +1)/7. The median DR was estimated using Kaplan-Meier estimates. | From the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum 374 weeks) |
| Percentage of Participants Surviving at 6 Months and 1 Year | The probability of survival at 6 months and 1 year, respectively, after the date of the first dose based on the Kaplan-Meier estimate. | At 6 months and 1 year after first dose |
| Overall Survival (OS) | OS is defined as the time from the date of first dose of study medication to the date of death due to any cause. OS (in months) was calculated as (date of death - date of first dose +1)/30.42. For participants still alive at the time of the analysis, for those who were lost to follow-up, and those who withdrew consent for additional follow up, the OS was censored on the last date that participants were known to be alive. Participants lacking data beyond the first dose had their OS censored at the date of first dose. The median OS was estimated using Kaplan-Meier method. | From the first dose of study treatment to the date of death due to any cause (maximum 444 weeks) |
| Steady-State Pre-dose Concentration (Ctrough) for Crizotinib on Day 1 of Cycles 2, 3 and 5 | Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. | Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5 |
| Steady-State Ctrough for PF-06260182 on Day 1 of Cycles 2, 3 and 5 | Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. | Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5 |
| Ctrough Ratios of PF-06260182 to Crizotinib on Day 1 of Cycles 2, 3 and 5 | Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. The ratio is calculated as: (PF-06260182 concentration/464.33)/(Crizotinib concentration/450.34), where 464.33 is molecular weight for PF-06260182 and 450.33 is molecular weight for Crizotinib. | Predose within -1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5 |
| Number of Participants With ALK Genetic Events | Number of participants with ALK translocation/fusion, amplification, mutation and overexpression at baseline assessed by technologies including fluorescence in-situ hybridization (FISH), immunohistochemistry (IHC), quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), ALK Fusion partners assessed by FISH or PCR; ALK gene amplification assessed by FISH or array Comparative Genomic Hybridization (aCGH), ALK Mutation assessed by PCR or direct sequencing were reported. | From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years) |
| Phosphorylation Status of ALK in the Tumor Samples From Surgery or Biopsy Pre and Post Treatment | Tumor sample was planned to be provided to the designated central laboratory for retrospective confirmation of ALK phosphorylation status by a Pfizer designated central laboratory. The molecular profiling results were planned to include ALK fusion/translocation, mutations, amplification and overexpression. | From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years) |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Highland Oncology Group | Springdale | Arkansas | 72762 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| OHSU Center for Health and Healing 2 | Portland | Oregon | 97239 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Greenville Health System, Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | United States |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Chaoyang District | 100021 | China |
| SUN Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Centro di Ricerca di Fase 1 ASST-Monza | Monza | 20090 | Italy |
| PO San Gerardo, ASST Monza-U.O Ematologia | Monza | 20900 | Italy |
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health | Saint Petersburg | 197022 | Russia |
| Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva | Saint Petersburg | 197101 | Russia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| National Taiwan University Hospital, Department of Internal Medicine | Taipei | 100 | Taiwan |
| FG001 | IMT Arm | In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| FG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline population included all enrolled participants who received at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALCL Arm | In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| BG001 | IMT Arm | In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| BG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The data for age was provided for the overall population and the pediatric population. Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study. Number Analyzed for Pediatric Population = Number of participants <18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study. | Median | Full Range | Years |
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| Age, Customized | Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study. | Count of Participants | Participants |
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| Sex: Female, Male | The data for sex was provided for the overall population and the pediatric population. Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study. Number Analyzed for Pediatric Population = Number of participants <18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Racial Designation for pediatric population. | Number Analyzed for Pediatric Population = Number of participants <18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care activity of daily living (ADL); Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. | All enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks) |
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| Primary | Number of Participants With All-Causality TEAEs in the Pediatric Population | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication.Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. | Enrolled pediatric (<18 years old) participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks) |
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| Primary | Number of Participants With Treatment-Related TEAEs | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. | All enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks) |
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| Primary | Number of Participants With Treatment-Related TEAEs in the Pediatric Population | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. | Enrolled pediatric (<18 years old) participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks) |
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| Primary | Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries) | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and clinical chemistry parameters were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. | Number analyzed = Number of participants with a postbaseline value during the study treatment for this outcome measure for each specified row. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks) |
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| Primary | Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries) in the Pediatric Population | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and chemistry laboratory assessments were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Unplanned laboratory test results were also included. | Enrolled pediatric (<18 years old) participants who received at least 1 dose of study treatment and had both baseline and post-baseline values. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks) |
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| Primary | Objective Response Rate (ORR) - Percentage of Participants With Objective Response | Percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) as determined by the investigators. CR = disappearance of all target lesions. PR = greater than equal to (>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. ORR based on Cheson criteria was defined similarly however, confirmation of response was not required. If participant had tumor response assessed only by RECIST or Cheson, then ORR was based on the single result. If tumor response was assessed by both RECIST and Cheson, then ORR was reported based on tumor response by Cheson criteria unless the Cheson has indeterminate result, in which case the RECIST result was reported. Participant(s) who did not have tumor assessment results from either RECIST 1.1 or Cheson criteria reported at baseline were to be excluded from the analysis. | All participants who were enrolled and received at least 1 dose of study treatment, and had adequate baseline tumor assessment by either RECIST 1.1 or Cheson criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occured first (maximum 374 weeks) |
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| Secondary | Progression-Free Survival (PFS) Based on Investigator Assessement | PFS was defined as the time from the date of first dose of study medication to the date of the first documentation of objective tumor progression (at least a 20% increase in the sum of 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. The appearance of one or more new lesions is also considered a sign of progression) or death on treatment due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. The median PFS was estimated using Kaplan-Meier method. | All enrolled participants who received at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | From the date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occurs first (maximum 444 weeks) |
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| Secondary | Duration of Response (DR) Based on Investigator Assessement | DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. CR: disappearance of all lesions; any pathological lymph nodes (target lesions [TLs]) or non-target lesions (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; PR: >=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters; DR (in weeks) was calculated as (first date of PD or death - first date of CR or PR +1)/7. The median DR was estimated using Kaplan-Meier estimates. | Participants enrolled and treated who had baseline tumor assessment result and had confirmed CR or PR. | Posted | Median | 95% Confidence Interval | Weeks | From the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum 374 weeks) |
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| Secondary | Percentage of Participants Surviving at 6 Months and 1 Year | The probability of survival at 6 months and 1 year, respectively, after the date of the first dose based on the Kaplan-Meier estimate. | Enrolled participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 6 months and 1 year after first dose |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the date of first dose of study medication to the date of death due to any cause. OS (in months) was calculated as (date of death - date of first dose +1)/30.42. For participants still alive at the time of the analysis, for those who were lost to follow-up, and those who withdrew consent for additional follow up, the OS was censored on the last date that participants were known to be alive. Participants lacking data beyond the first dose had their OS censored at the date of first dose. The median OS was estimated using Kaplan-Meier method. | Enrolled participants who received at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | From the first dose of study treatment to the date of death due to any cause (maximum 444 weeks) |
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| Secondary | Steady-State Pre-dose Concentration (Ctrough) for Crizotinib on Day 1 of Cycles 2, 3 and 5 | Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. | Number of Participants Analyzed = participants who were enrolled and treated, had at least 1 PK blood sample collected, and were evaluable for steady-state Ctrough analysis. Number Analyzed = participants evaluable for this OM and had Ctrough data on the specific day. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5 |
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| Secondary | Steady-State Ctrough for PF-06260182 on Day 1 of Cycles 2, 3 and 5 | Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. | Number of Participants Analyzed = participants who were enrolled and treated, had at least 1 PK blood sample collected, and were evaluable for steady-state Ctrough analysis. Number Analyzed = participants evaluable for this OM and had Ctrough data on the specific day. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Ctrough Ratios of PF-06260182 to Crizotinib on Day 1 of Cycles 2, 3 and 5 | Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. The ratio is calculated as: (PF-06260182 concentration/464.33)/(Crizotinib concentration/450.34), where 464.33 is molecular weight for PF-06260182 and 450.33 is molecular weight for Crizotinib. | Number of Participants Analyzed = participants who were enrolled and treated, had at least 1 PK blood sample collected, and were evaluable for steady-state Ctrough analysis. Number Analyzed = participants evaluable for this OM and had Ctrough data on the specific day. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Predose within -1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With ALK Genetic Events | Number of participants with ALK translocation/fusion, amplification, mutation and overexpression at baseline assessed by technologies including fluorescence in-situ hybridization (FISH), immunohistochemistry (IHC), quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), ALK Fusion partners assessed by FISH or PCR; ALK gene amplification assessed by FISH or array Comparative Genomic Hybridization (aCGH), ALK Mutation assessed by PCR or direct sequencing were reported. | The analysis planned to include all participant who had at least one dose of study treatment and at least one data of molecular profiling. Number Analyzed = participants who were enrolled and evaluable for this OM that had ALK genetic events at baseline. | Posted | Count of Participants | Participants | From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Phosphorylation Status of ALK in the Tumor Samples From Surgery or Biopsy Pre and Post Treatment | Tumor sample was planned to be provided to the designated central laboratory for retrospective confirmation of ALK phosphorylation status by a Pfizer designated central laboratory. The molecular profiling results were planned to include ALK fusion/translocation, mutations, amplification and overexpression. | Analysis population included all participant who had at least one dose of study treatment and at least one data of molecular profiling at baseline and at end of treatment. Data were not collected due to that post-treatment tumor sample collection was optional per protocol and no participant had the post-treatment sample taken. | Posted | From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years) |
|
From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum duration between first and last dose: 444 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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 | ALCL Arm | In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. | 5 | 17 | 8 | 17 | 16 | 17 |
| EG001 | IMT Arm | In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. | 3 | 9 | 4 | 9 | 9 | 9 |
| EG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. | 13 | 18 | 7 | 18 | 17 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Eyelid folliculitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Paternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood folate decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood testosterone decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Globulins decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Petit mal epilepsy | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Visual perseveration | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hair disorder | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Mechanical urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abscess drainage | Surgical and medical procedures | MedDRA v26.0 | Non-systematic Assessment |
| |
| Mole excision | Surgical and medical procedures | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2019 | Apr 2, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
Not provided
Not provided
|
| Pediatric Population |
|
|
|
|
| Pediatric Population |
|
|
|
| Black |
|
|
| Asian |
|
|
|
| Black |
|
|
| Asia |
|
|
| Title | Measurements |
|---|---|
|
| Maximum Grade 3 or 4 AEs |
|
| Maximum Grade 5 AEs |
|
| AEs resulting in study treatment discontinuation (participant continued study) |
|
| AEs resulting in dose reduction |
|
| AEs resulting in temporary discontinuation of study treatment |
|
| OG001 |
| IMT Arm |
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG001 |
| IMT Arm |
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG001 | IMT Arm | In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG001 | IMT Arm | In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| IMT Arm |
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG001 | IMT Arm | In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| Other Tumors |
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
|
| OG002 | Other Tumors | In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator. |
|
| Male |
|