CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 596 enrolled
Drug / intervention
PF-02341066 +2 moredrug
Likely dose
PF-02341066 50 mgfrom 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/NCT00585195
NCT00585195Phase 1Completed
CompareCT.gov

PHASE 1 SAFETY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF PF-02341066, A MET/HGFR SELECTIVE TYROSINE KINASE INHIBITOR, ADMINISTERED ORALLY TO PATIENTS WITH ADVANCED CANCER

Pfizer·interventional·Posted Jan 3, 2008·Updated Feb 8, 2023

In Brief

A Phase 1 clinical trial evaluating PF-02341066, Rifampin, and 1 other intervention for Non-Small Cell Lung Cancer ALK-positive and 4 related conditions. Completed, enrolled 596 participants across 29 sites in 4 countries.

Detailed Summary

PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-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
CountriesAustralia, Japan, South Korea, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 3, 2008
Enrollment StartApr 19, 2006
Primary CompletionJul 30, 2020
Study CompletionJan 19, 2022
TodayJul 2, 2026
Enrollment to primary: 14.3 yearsPosted 18.5 years ago

Interventions

PF-02341066drug

Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days (or 21 days depending on the cohort).

Rifampindrug

600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.

Itraconazoledrug

Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.