A Phase 1 interventional study of Crizotinib in Neoplasms Malignant, sponsored by Pfizer. Terminated at 21 sites in 7 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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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Exclusion Criteria:
Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Also known as: PF-02341066
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years)
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).
| Milestone | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Started | 17 | 9 | 18 |
| Completed | 0 | 0 | 0 |
| Not completed | 17 | 9 | 18 |
| Withdrew: Death | 5 | 3 | 13 |
| Withdrew: Study terminated by sponsor | 1 | 1 | 0 |
| Withdrew: Participant refused further followup | 2 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 |
| Withdrew: Non-specified reasons | 9 | 4 | 2 |
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.
| Participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| AEs | 17 | 9 | 17 |
| SAEs | 8 | 4 | 7 |
| Maximum Grade 3 or 4 AEs | 13 | 7 | 8 |
| Maximum Grade 5 AEs | 2 | 0 | 4 |
| AEs resulting in study treatment discontinuation (participant continued study) | 1 | 0 | 3 |
| AEs resulting in dose reduction | 4 | 1 | 3 |
| AEs resulting in temporary discontinuation of study treatment | 8 | 6 | 10 |
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.
| Participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| AEs | 3 | 2 | — |
| SAEs | 2 | 1 | — |
| Maximum Grade 3 or 4 AEs | 3 | 2 | — |
| Maximum Grade 5 AEs | 0 | 0 | — |
| AEs resulting in study treatment discontinuation (participant continued study) | 0 | 0 | — |
| AEs resulting in dose reduction | 1 | 0 | — |
| AEs resulting in temporary discontinuation of study treatment | 2 | 2 | — |
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.
| Participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| AEs | 16 | 8 | 15 |
| SAEs | 5 | 3 | 2 |
| Maximum Grade 3 or 4 AEs | 11 | 5 | 6 |
| Maximum Grade 5 AEs | 0 | 0 | 2 |
| AEs resulting in study treatment discontinuation (participant continued study treatment) | 0 | 0 | 2 |
| AEs resulting in dose reduction | 4 | 1 | 3 |
| AEs resulting in temporary discontinuation of study treatment | 6 | 4 | 6 |
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.
| Participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| AEs | 3 | 2 | — |
| SAEs | 2 | 1 | — |
| Maximum Grade 3 or 4 AEs | 2 | 1 | — |
| Maximum Grade 5 AEs | 0 | 0 | — |
| AEs resulting in study treatment discontinuation (participant continued study treatment) | 0 | 0 | — |
| AEs resulting in dose reduction | 1 | 0 | — |
| AEs resulting in temporary discontinuation of study treatment | 1 | 1 | — |
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.
| Participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Anemia | 1 | 0 | 5 |
| Hemoglobin increased | 0 | 0 | 0 |
| Lymphocyte count decreased | 1 | 1 | 4 |
| Lymphocyte count increased | 0 | 0 | 0 |
| Neutrophil count decreased | 8 | 3 | 1 |
| Platelet count decreased | 0 | 0 | 0 |
| White blood cell decreased | 3 | 0 | 1 |
| Alanine aminotransferase increased | 2 | 1 | 2 |
| Alkaline phosphatase increased | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 4 | 0 | 1 |
| Blood bilirubin increased | 0 | 0 | 1 |
| Creatinine increased | 0 | 0 | 0 |
| Hypercalcemia | 0 | 0 | 0 |
| Hyperglycemia | 0 | 0 | 0 |
| Hyperkalemia | 2 | 0 | 0 |
| Hypermagnesemia | 0 | 0 | 1 |
| Hypernatremia | 0 | 0 | 0 |
| Hypoalbuminemia | 0 | 0 | 2 |
| Hypocalcemia | 0 | 0 | 0 |
| Hypoglycemia | 2 | 0 | 0 |
| Hypokalemia | 0 | 0 | 2 |
| Hypomagnesemia | 0 | 0 | 0 |
| Hyponatremia | 0 | 0 | 2 |
| Hypophosphatemia | 3 | 0 | 1 |
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.
| Participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Anemia | 0 | 0 | 0 |
| Hemoglobin increased | 0 | 0 | 0 |
| Lymphocyte count decreased | 1 | 0 | 0 |
| Lymphocyte count increased | 0 | 0 | 0 |
| Neutrophil count decreased | 2 | 1 | 0 |
| Platelet count decreased | 0 | 0 | 0 |
| White blood cell decreased | 2 | 0 | 0 |
| Alanine aminotransferase increased | 0 | 0 | 0 |
| Alkaline phosphatase increased | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 1 | 0 | 0 |
| Blood bilirubin increased | 0 | 0 | 0 |
| Creatinine increased | 0 | 0 | 0 |
| Hypercalcemia | 0 | 0 | 0 |
| Hyperglycemia | 0 | 0 | 0 |
| Hyperkalemia | 0 | 0 | 0 |
| Hypermagnesemia | 0 | 0 | 0 |
| Hypernatremia | 0 | 0 | 0 |
| Hypoalbuminemia | 0 | 0 | 0 |
| Hypocalcemia | 0 | 0 | 0 |
| Hypoglycemia | 1 | 0 | 0 |
| Hypokalemia | 0 | 0 | 0 |
| Hypomagnesemia | 0 | 0 | 0 |
| Hyponatremia | 0 | 0 | 0 |
| Hypophosphatemia | 1 | 0 | 0 |
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.
| Percentage of participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response | 56.3 (33.2 to 76.9) | 66.7 (35.4 to 87.9) | 16.7 (5.8 to 39.2) |
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.
| Months | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Progression-Free Survival (PFS) Based on Investigator Assessement | NA (2.1 to NA) | NA (11.1 to NA) | 1.4 (1.1 to 4.9) |
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.
| Weeks | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Duration of Response (DR) Based on Investigator Assessement | NA (NA to NA) | NA (30.1 to NA) | NA (16.1 to NA) |
The probability of survival at 6 months and 1 year, respectively, after the date of the first dose based on the Kaplan-Meier estimate.
| Percentage of participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| 6 Months | 76.5 (48.8 to 90.4) | 100.0 (100.0 to 100.0) | 52.9 (27.6 to 73.0) |
| 1 Year | 70.6 (43.1 to 86.6) | 100.0 (100.0 to 100.0) | 52.9 (27.6 to 73.0) |
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.
| Months | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Overall Survival (OS) | NA (7.5 to NA) | NA (32.1 to NA) | 12.6 (2.2 to 27.0) |
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.
| nanogram per milliliter (ng/mL) | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Cycle 2 Day 1 | 270 ± 46.2 | 266 ± 42.0 | 233 ± 101 |
| Cycle 3 Day 1 | 316 ± 33.4 | 179 ± 92.1 | 187 ± 224 |
| Cycle 5 Day 1 | 244 ± 80.0 | 257 ± 35.1 | 347 ± 63.1 |
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.
| ng/mL | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Cycle 2 Day 1 | 79.7 ± 64.6 | 68.2 ± 56.4 | 54.6 ± 123 |
| Cycle 3 Day 1 | 85.4 ± 88.2 | 41.7 ± 147 | 50.5 ± 566 |
| Cycle 5 Day 1 | 81.7 ± 96.8 | 71.9 ± 48.2 | 91.7 ± 68.7 |
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.
| Ratio | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Cycle 2 Day 1 | 0.323 ± 15.2 | 0.249 ± 25.0 | 0.190 ± 32.7 |
| Cycle 3 Day 1 | 0.314 ± 26.0 | 0.226 ± 41.4 | 0.126 ± 108 |
| Cycle 5 Day 1 | 0.326 ± 28.3 | 0.270 ± 27.7 | 0.243 ± 28.0 |
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.
| Participants | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| ALK FISH | 2 | 9 | 12 |
| ALK Fusion Partner | 1 | 1 | 2 |
| ALK RT-PCR | 4 | 0 | 2 |
| ALK Gene Amplification | 0 | 0 | 3 |
| ALK IHC | 15 | 1 | 3 |
| ALK Mutation | 0 | 0 | 4 |
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.
No measurements were reported for this outcome.
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ALCL Arm | 5/17 (29.4%) | 8/17 (47.1%) | 16/17 (94.1%) |
| IMT Arm | 3/9 (33.3%) | 4/9 (44.4%) | 9/9 (100%) |
| Other Tumors | 13/18 (72.2%) | 7/18 (38.9%) | 17/18 (94.4%) |
| Event | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| Blood creatine phosphokinase increasedInvestigations | 3/17 | 1/9 | 0/18 |
| Disease progressionGeneral disorders | 2/17 | 0/9 | 1/18 |
| Cardiac failure congestiveCardiac disorders | 0/17 | 1/9 | 0/18 |
| Myocardial ischaemiaCardiac disorders | 0/17 | 1/9 | 0/18 |
| Eyelid ptosisEye disorders | 0/17 | 1/9 | 0/18 |
| Visual acuity reducedEye disorders | 0/17 | 1/9 | 0/18 |
| DiarrhoeaGastrointestinal disorders | 0/17 | 1/9 | 0/18 |
| Small intestinal obstructionGastrointestinal disorders | 0/17 | 1/9 | 0/18 |
| VomitingGastrointestinal disorders | 0/17 | 1/9 | 0/18 |
| SepsisInfections and infestations | 0/17 | 1/9 | 0/18 |
| Event | ALCL Arm | IMT Arm | Other Tumors |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 11/17 | 3/9 | 6/18 |
| VomitingGastrointestinal disorders | 10/17 | 3/9 | 6/18 |
| PyrexiaGeneral disorders | 10/17 | 1/9 | 2/18 |
| Aspartate aminotransferase increasedInvestigations | 10/17 | 4/9 | 6/18 |
| NauseaGastrointestinal disorders | 6/17 | 5/9 | 7/18 |
| Alanine aminotransferase increasedInvestigations | 9/17 | 4/9 | 5/18 |
| Visual impairmentEye disorders | 8/17 | 4/9 | 5/18 |
| NeutropeniaBlood and lymphatic system disorders | 7/17 | 4/9 | 3/18 |
| AstheniaGeneral disorders | 7/17 | 0/9 | 2/18 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/17 | 1/9 | 4/18 |
Baseline population included all enrolled participants who received at least one dose of study intervention.
| Age, Continuous(Years) | ALCL Arm | IMT Arm | Other Tumors | Total |
|---|---|---|---|---|
| Overall Population | 25.0 (15.0 to 37.0) | 32.0 (16.0 to 73.0) | 49.0 (18.0 to 73.0) | 32.0 (15.0 to 73.0) |
| Pediatric Population | 15.0 (15.0 to 16.0) | 16.5 (16.0 to 17.0) | — | 16.0 (15.0 to 17.0) |
| Age, Customized(Participants) | ALCL Arm | IMT Arm | Other Tumors | Total |
|---|---|---|---|---|
| <18 | 3 | 2 | 0 | 5 |
| Between 18 and 65 years | 14 | 6 | 15 | 35 |
| >=65 years | 0 | 1 | 3 | 4 |
| Sex: Female, Male(Participants) | ALCL Arm | IMT Arm | Other Tumors | Total |
|---|---|---|---|---|
| Overall population — Female | 5 | 4 | 10 | 19 |
| Overall population — Male | 12 | 5 | 8 | 25 |
| Pediatric Population — Female | 1 | 1 | 0 | 2 |
| Pediatric Population — Male | 2 | 1 | 0 | 3 |
| Race/Ethnicity, Customized(Participants) | ALCL Arm | IMT Arm | Other Tumors | Total |
|---|---|---|---|---|
| White | 12 | 4 | 7 | 23 |
| Black | 0 | 0 | 0 | 0 |
| Asian | 5 | 5 | 11 | 21 |
| Race/Ethnicity, Customized(Participants) | ALCL Arm | IMT Arm | Other Tumors | Total |
|---|---|---|---|---|
| White | 1 | 0 | 0 | 1 |
| Black | 0 | 0 | 0 | 0 |
| Asia | 2 | 2 | 0 | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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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