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Trial record 1 of 1 for:    NCT00585195
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585195
Recruitment Status : Active, not recruiting
First Posted : January 3, 2008
Last Update Posted : October 1, 2020
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
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 Drug: PF-02341066 Drug: Rifampin Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 596 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 19, 2006
Actual Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 2.5 years ]
    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.

  2. Area under the Concentration-Time Curve (AUC) [ Time Frame: 2.0 years ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  3. Maximum tolerated dose (MTD) [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Percentage of Participants With Objective Response [ Time Frame: 4.0 years ]
    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).

  2. Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with rifampin [ Time Frame: 2.0 years ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  3. Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with itraconazole [ Time Frame: 3.0 years ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585195

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Pfizer Identifier: NCT00585195    
Other Study ID Numbers: A8081001
PROFILE 1001 ( Other Identifier: Alias Study Number )
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lymphoma, Large-Cell, Anaplastic
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists