Trial record 1 of 1 for:    A8081001
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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 August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00585195
First received: December 29, 2007
Last updated: August 12, 2014
Last verified: August 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
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: November 2017
Estimated Primary Completion Date: November 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

Locations
United States, California
Pfizer Investigational Site Recruiting
Orange, California, United States, 92868
United States, Colorado
Pfizer Investigational Site Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Pfizer Investigational Site Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Pfizer Investigational Site Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Pfizer Investigational Site Recruiting
Basking Ridge, New York, United States, 07920
Pfizer Investigational Site Recruiting
Commack, New York, United States, 11725
Pfizer Investigational Site Recruiting
New York, New York, United States, 10065
Pfizer Investigational Site Recruiting
New York, New York, United States, 10022
Pfizer Investigational Site Recruiting
New York, New York, United States, 10021
Pfizer Investigational Site Recruiting
Rockville Centre, New York, United States, 11570
Pfizer Investigational Site Recruiting
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Pfizer Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27514
Pfizer Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
Pfizer Investigational Site Recruiting
Columbus, Ohio, United States, 43221
Pfizer Investigational Site Recruiting
Columbus, Ohio, United States, 43210
Pfizer Investigational Site Recruiting
Columbus, Ohio, United States, 43212
United States, Pennsylvania
Pfizer Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Pfizer Investigational Site Recruiting
Nashville, Tennessee, United States, 37232
Australia, Victoria
Pfizer Investigational Site Recruiting
East Melbourne, Victoria, Australia, 3002
Korea, Republic of
Pfizer Investigational Site 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
Study First Received: December 29, 2007
Last Updated: August 12, 2014
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
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Rifampin
Itraconazole
Crizotinib
Hydroxyitraconazole
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014