Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion:

Description

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.

Official Title

Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of Pf-02341066, A C-met/Hgfr Selective Tyrosine Kinase Inhibitor, Administered Orally To Patients With Advanced Cancer

Keywords

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 Crizotinib dose-finding drug-drug interaction ALK rearrangements c-Met mutations or amplifications c-Met dependent tumors ROS1 rearrangements c-Met exon 14 deletion c-Met exon 14 skipping c-Met exon 14 alterations Lung Neoplasms Carcinoma, Non-Small-Cell Lung Lymphoma, Large-Cell, Anaplastic Itraconazole Hydroxyitraconazole Rifampin PF-02341066

Eligibility

You can join if…

Open to people ages 18 years and up

  • Advanced malignancies (except leukemias), histologically proven at diagnosis;Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
  • Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
  • Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)

You CAN'T join if...

  • Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
  • Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
  • Active or unstable cardiac disease or heart attack within 3 months of starting study treatment

Locations

  • University of California, Irvine Medical Center accepting new patients
    Orange California 92868-3201 United States
  • University of Colorado Hospital/ Anschutz Cancer Pavilion accepting new patients
    Aurora Colorado 80045 United States
  • University of Colorado Hospital accepting new patients
    Aurora Colorado 80045 United States
  • University of Colorado accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT00585195
Phase
Phase 1
Study Type
Interventional
Last Updated