A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Official Title

Phase 1/2 Study Of Pf-06463922 (an Alk/ros1 Tyrosine Kinase Inhibitor) In Patients With Advanced Non-small Cell Lung Cancer Harboring Specific Molecular Alterations

Summary:

Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .

Trial Description

Primary Outcome:

  • Percentage of Patients with Overall and Intracranial Objective Response (Phase 2)
  • Cycle 1 Dose Limiting Toxicities (DLTs). (Phase 1)
Secondary Outcome:
  • Adverse Events
  • Change from Baseline in Mini Mental State Examination (MMSE) across treatment cycles (Phase 1)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Phase 1 and first 10 patients in Phase 2)
  • Volume of Distribution at Steady State (Vz/F) (Phase 1 and first 10 patients in Phase 2)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax)(Phase 1 and first 10 patients in Phase 2)
  • Maximum Observed Plasma Concentration (Cmax)(Phase 1 and first 10 patients in Phase 2)
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau)(Phase 1 and first 10 patients in Phase 2)
  • Apparent Volume of Distribution (Vz/F)(Phase 1 and first 10 patients in Phase 2)
  • Plasma Decay Half-Life (t1/2) (Phase 1 and first 10 patients in Phase 2)
  • Urine clearance of drug (Clr) for subjects in food effect and Midazolam substudy (Phase 1)
  • Urine Ae% for subjects in food effect and Midazolam substudy (Phase 1)
  • Maximum Observed Plasma Concentration (Cmax) for subjects in Midazolam substudy (Phase 1)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for subjects in Midazolam substudy (Phase 1)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for subjects in Midazolam substudy (Phase 1)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)](Phase 1 and first 10 patients in Phase 2)
  • Plasma Decay Half-Life (t1/2) for subjects in Midazolam substudy (Phase 1)
  • Apparent Oral Clearance (CL/F) for subjects in Midazolam substudy (Phase 1)
  • Apparent Oral Clearance (CL/F) (Phase 1)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Phase 1 and first 10 patients in Phase 2)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)](Phase 1 and first 10 patients in Phase 2)
  • Selective molecular profiling of circulating nucleic acids (CNA)
  • Selective molecular profiling of tumour tissue
  • QTc interval
  • Patient reported Outcomes
  • Duration of Response
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Disease Control Rate (DCR)
  • Objective tumour response
  • Left Ventricular Ejection Fraction (LVEF)
  • Apparent Volume of Distribution (Vz/F) for subjects in Midazolam substudy (Phase 1)
  • Time to Tumour Response
  • Time to Tumour Progression (Phase 2)
  • Time to Intracranial progression (Phase 2)
  • Time to Extracranial Progression (Phase 2)
  • Vital signs
  • Cognitive Function Assessment (Phase 2)
  • Adverse events for patients receiving crizotinib following PF-06463922 (Phase 2)
  • Laboratory abnormalities for patients receiving crizotinib following PF-06463922 (Phase 2)
  • Objective tumour response, as assessed by Response Evaluation Criteria in Solid Tumour (RECIST) version 1.1 for patients receiving crizotinib following PF-06463922 (Phase 2)
  • Progression Free Survival (PFS) for patients receiving crizotinib following PF-06463922 (Phase 2)
  • Duration of Response for patients receiving crizotinib following PF-06463922 (Phase 2)
  • Time to Tumour Response in patients receiving crizotinib following PF-06463922 (Phase 2)
  • Overall Survival for patients receiving crizotinib following PF-06463922 (Phase 2)
  • Mood Assessment (Phase 2)
  • Suicidal Ideation and Behaviour Assessment (Phase 2)
  • Laboratory abnormalities

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society