Clinical Trials /

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

NCT00585195

Description:

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.

Related Conditions:
  • Cancer
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: A8081001
  • SECONDARY ID: PROFILE 1001
  • NCT ID: NCT00585195

Conditions

  • 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

Interventions

DrugSynonymsArms
PF-023410661
Rifampin1
Itraconazole1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
1Experimental
  • PF-02341066
  • Rifampin
  • Itraconazole

Eligibility Criteria

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame:2.5 years
Safety Issue:
Description:Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Secondary Outcome Measures

Measure:Percentage of Participants With Objective Response
Time Frame:4.0 years
Safety Issue:
Description:Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measure:Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with rifampin
Time Frame:2.0 years
Safety Issue:
Description:AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measure:Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with itraconazole
Time Frame:3.0 years
Safety Issue:
Description:AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • 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

Last Updated

January 29, 2018