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

NCT01970865 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2024-08-12

Study results available
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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 .

Conditions

  • ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC

Interventions

DRUG

PF-06463922

Oral, starting dose 10mg once a day, dose escalation in Phase 1 until recommended Phase 2 dose determined, continuous daily dosing, cycles lasting 21 days

DRUG

Crizotinib

Oral, starting dose of 250 mg BID continuous daily dosing every 21 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-08
Primary Completion
2017-03-15
Completion
2023-05-24

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970865 on ClinicalTrials.gov