A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
Condition: 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
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lymphoma, Large-Cell, Anaplastic
Intervention: PF-02341066; Rifampin; Itraconazole
Intervention description: 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).; 600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.; Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.
Intervention MeSH terms: Itraconazole; Rifampin; Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 596.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

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