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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Systemic Anaplastic Large-Cell Lymphoma, Neoplasms, Anaplastic Lymphoma Kinase, Human, NSCLC

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Trial Information

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


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 6 months of starting study
treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To test the safety of PF-02341066 when taken by people who have cancer

Outcome Time Frame:

2.5 years

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8081001

NCT ID:

NCT00585195

Start Date:

April 2006

Completion Date:

July 2015

Related Keywords:

  • Systemic Anaplastic Large-Cell Lymphoma
  • Neoplasms
  • Anaplastic Lymphoma Kinase, Human
  • NSCLC
  • Crizotinib
  • Tumors positive for ALK/c-Met/ rearrangements
  • mutations or amplifications
  • Tumors with chromosomal translocations at the ROS gene
  • Neoplasms
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteNorth Adams, Massachusetts  01247