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Clinical Trial VICCPHI1255

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

Principal Investigator(s)

Vicki Keedy

Details

  • Protocol No. VICCPHI1255
  • Open Date: 09/28/2013
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: Determine the safety profile of PF-02341066 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD).
  • Disease Sites: Phase I
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Crizotinib; PF-02341066; Rifampin
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT00585195
  • Secondary Protocol No: A8081001

Description

You are being asked to take part in this research study because you have advanced cancer that may not be responding to standard of care therapy, or because there is no current standard of care therapy available for you. This study is being done to find out the good and bad effects of a research study drug, called PF-02341066. The PF-02341006 study drug is an oral anti-cancer drug made by Pfizer, Inc. which inhibits the tumor activity of the ALK gene fusion. PF-02341066, also known as crizotinib, has been given to more than 1000 people worldwide for ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). On 26 August 2011, PF-02341066 (XALKORI) was approved by the United States Food and Drug Administration (FDA) for treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test. This is the first study in which PF-02341066 is being given to cancer patients, and this study has been ongoing since May 2006. It has also been tested in animals and has been shown to have anti-tumor activity in animals. This drug is being used in this study for indications that are not FDA approved and is considered investigational. The purposes of this study are: To test the safety of PF-02341066; to compare the amount of PF-02341066 in your blood after you take different strengths, to test if there are reactions to single and increased doses of PF-02341066, to determine the best dose level (how many milligrams of study drug per day) for PF-02341066 in patients, to measure how much of PF-02341066 is in your blood after you take the study drug.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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