A Study Of Oral PF-02341066, A c-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer (PROFILE 1001)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00585195
First received: December 29, 2007
Last updated: April 20, 2015
Last verified: April 2015
  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
Non-Small Cell Lung Cancer (ALK-positive)
Non-Small Cell Lung Cancer (c-Met-amplified)
Non-Small Cell Lung Cancer (ROS Marker Positive)
Systemic Anaplastic Large-Cell Lymphoma
Drug: PF-02341066
Drug: Rifampin
Drug: Itraconazole
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:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
    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.

  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 2.0 years ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • Maximum tolerated dose (MTD) [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants With Objective Response [ Time Frame: 4.0 years ] [ Designated as safety issue: No ]
    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).

  • Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with rifampin [ Time Frame: 2.0 years ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with itraconazole [ Time Frame: 3.0 years ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.


Estimated Enrollment: 550
Study Start Date: April 2006
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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: Itraconazole

Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.

Single and Multiple Dose Design:200 mg QD administered from Day -3 to Cycle 1, Day 16 (19 days) 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 3 months of starting study treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585195

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

  Hide Study Locations
Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
University of California, Irvine Medical Center Pharmacy Recruiting
Orange, California, United States, 92868
United States, Colorado
Drug Shipment: Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Center Recruiting
Boston, Massachusetts, United States, 02215
Joslin Beetham Eye Institute Recruiting
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Kresge Eye Institute Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Memorial Sloan-Kettering Rockefeller Outpatient Pavillion Recruiting
New York, New York, United States, 10022
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10022
United States, North Carolina
UNC Cancer Hospital Recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
The James Cancer Hospital and Solove Research Institute Recruiting
Colombus, Ohio, United States, 43210
Ohio State Eye and Ear Institute Recruiting
Colombus, Ohio, United States, 43212
The Ohio State University Martha Morehouse Medical Plaza Recruiting
Columbus, Ohio, United States, 43221
The Ohio State University Medical Center Investigator Drug Services Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
UPMC Hillman Cancer Center - Investigational Drug Service Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Henry-Joyce Cancer Clinic Recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt Eye Institute Recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt Oncology Pharmacy Recruiting
Nashville, Tennessee, United States, 37232
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 3002
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
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, PROFILE 1001
Study First Received: December 29, 2007
Last Updated: April 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Crizotinib
dose-finding
drug-drug interaction
ALK or c-Met rearrangements
mutations or amplifications
or chromosomal translocations in the ROS gene

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Lymphoma, Large-Cell, Anaplastic
Bronchial Neoplasms
Carcinoma, Bronchogenic
Immune System Diseases
Immunoproliferative Disorders
Lung Diseases
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Crizotinib
Itraconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015