{"commentary":{"count":23,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":11,"podcast":9,"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT00585195\", \"email\": \"\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"PROFILE 1001","nct_id":"NCT00585195","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=profile-1001-nct00585195. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"PROFILE 1001","arms":[{"description":null,"label":"1","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2022-01-19","type":"ACTUAL"},"conditions":["Non-Small Cell Lung Cancer ALK-positive","Non-Small Cell Lung Cancer c-Met Dependent","Non-Small Cell Lung Cancer ROS Marker Positive","Systemic Anaplastic Large-Cell Lymphoma","Advanced Malignancies Except Leukemia"],"enrollment":{"count":596,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"PF-02341066","type":"DRUG"},{"name":"Rifampin","type":"DRUG"},{"name":"Itraconazole","type":"DRUG"}],"last_update":"2023-02-08","lead_sponsor":"Pfizer","official_title":"PHASE 1 SAFETY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF PF-02341066, A MET/HGFR SELECTIVE TYROSINE KINASE INHIBITOR, ADMINISTERED ORALLY TO PATIENTS WITH ADVANCED CANCER","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2020-07-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib","timeFrame":"Cycle 1 (28 days)"},{"measure":"Dose-Escalation Cohort: Recommended Phase 2 Dose (RP2D) of Crizotinib","timeFrame":"Cycle 1 (28 days)"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Day -7","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose 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Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib on Cycle 2 Day 1","timeFrame":"Pre-dose on Cycle 2 Day 1"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Day -7","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 1 Day 1","timeFrame":"Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 1 Day 15","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 2 Day 1","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Day -7","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 1","timeFrame":"Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 15","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib Cycle 2 Day 1","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Plasma Decay Half-Life (t1/2) of Crizotinib on Day -7","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7"},{"measure":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAES) and Serious Adverse Events (SAEs)","timeFrame":"up to 189 Months"},{"measure":"Dose-Escalation Cohort: Number of Participants With Dose-limiting Toxicities (DLT)","timeFrame":"Cycle 1 (28 days)"},{"measure":"Midazolam Interaction Cohort: Maximum Observed Plasma Concentration (Cmax) of Midazolam When Taken Alone or Taken With Crizotinib","timeFrame":"pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Day -7 (midazolam alone arm), pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Cycle 2 Day 1 (midazolam with crizotinib arm)"},{"measure":"Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Midazolam When Taken Alone or Taken With Crizotinib","timeFrame":"pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Day -7 (midazolam alone arm), pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Cycle 2 Day 1 (midazolam with crizotinib arm)"},{"measure":"RP2D Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Crizotinib When Taken With Food","timeFrame":"pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7"},{"measure":"RP2D Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken With Food","timeFrame":"pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7"},{"measure":"Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib Alone and When Taken With Rifampin","timeFrame":"pre-dose, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)"},{"measure":"Rifampin Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib Alone and When Taken With Rifampin","timeFrame":"pre-dose, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone) and Cycle 2 Day 1 (Crizotinib with Rifampin)"},{"measure":"Rifampin Cohort: Ctrough of Crizotinib Alone and When Taken With Rifampin","timeFrame":"pre-dose on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)"},{"measure":"Itraconazole Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib When Taken Alone and When Taken With Itraconazole","timeFrame":"pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)"},{"measure":"Itraconazole Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken Alone and When Taken With Itraconazole","timeFrame":"pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)"},{"measure":"Itraconazole Cohort: Trough Plasma Concentration (Ctrough) of Crizotinib When Taken Alone and When Taken With Itraconazole","timeFrame":"pre-dose on Cycle 1 Day 15 (crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Objective Response (OR)","timeFrame":"Baseline up to 172 months"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Duration of Response (DOR)","timeFrame":"From first documentation of response to date of PD or death due to any cause (up to 172 months)"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Time to Response (TTR)","timeFrame":"From first dose until first documented response of PR or CR (up to 172 months)"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 8","timeFrame":"Week 8"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 16","timeFrame":"Week 16"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Progression Free Survival (PFS)","timeFrame":"From randomization until PD or death, whichever occurred first (up to 172 months)"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Probability of Being Event Free at Month 6","timeFrame":"From randomization to 6 months"},{"measure":"Recommended Phase 2 Dose (RP2D) Cohort: Overall Survival (OS)","timeFrame":"From randomization date to the date of death (up to 172 Months)"},{"measure":"Probability of Participant Survival at Month 6","timeFrame":"Month 6"},{"measure":"Probability of Participant Survival at Month 12","timeFrame":"Month 12"},{"measure":"Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 1 Day 15","timeFrame":"Baseline, Cycle 1 Day 15"},{"measure":"Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 2 Day 1","timeFrame":"Baseline, Cycle 2 Day 1"},{"measure":"Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 4 Day 1","timeFrame":"Baseline, Cycle 4 Day 1"},{"measure":"Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 6 Day 1","timeFrame":"Baseline, Cycle 6 Day 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