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

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00585195
First received: December 29, 2007
Last updated: April 3, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Systemic Anaplastic Large-Cell Lymphoma
Neoplasms
Anaplastic Lymphoma Kinase, Human
NSCLC
Drug: PF-02341066
Drug: Rifampin
Drug: Ketoconazole
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To test the safety of PF-02341066 when taken by people who have cancer [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • To assess how the body handles blood concentrations of PF-02341066 [ Time Frame: 2.0 years ] [ Designated as safety issue: No ]
  • To find the dose of PF-02341066 that should be used in future clinical trials [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-tumor activity [ Time Frame: 4.0 years ] [ Designated as safety issue: No ]
  • To assess how the body handles blood concentrations of PF-02341066 in the presence of another drug, rifampin [ Time Frame: 2.0 years ] [ Designated as safety issue: No ]
  • To assess how the body handles blood concentrations of PF-02341066 in the presence of another drug, ketoconazole [ Time Frame: 3.0 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 475
Study Start Date: April 2006
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-02341066
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).
Drug: Rifampin
600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.
Drug: Ketoconazole
200 mg BID administered from Cycle 1, Day 16 to Cycle 2, Day 1 (Cycle 2, Day 1 morning dose only; 13.5 days of dosing) in combination with PF-02341066.

  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 6 months of starting study treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585195

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 26 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00585195     History of Changes
Other Study ID Numbers: A8081001
Study First Received: December 29, 2007
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Crizotinib
Tumors positive for ALK/c-Met/ rearrangements
mutations or amplifications
Tumors with chromosomal translocations at the ROS gene

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Ketoconazole
Rifampin
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014