CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 364 enrolled
Drug / intervention
PF-06463922 +1 moredrug
Likely dose
PF-06463922 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01970865
NCT01970865Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Oct 28, 2013·Updated Aug 12, 2024

In Brief

A Phase 2 clinical trial evaluating PF-06463922 and Crizotinib for ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC. Completed, enrolled 364 participants across 77 sites in 14 countries.

Detailed 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 .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
CountriesAustralia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Singapore, South Korea, Spain, Switzerland, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 28, 2013
Enrollment StartJan 8, 2014
Primary CompletionMar 15, 2017
Study CompletionMay 24, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.7 years ago

Interventions

PF-06463922drug

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

Crizotinibdrug

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