A Study Of Oral PF-02341066, A c-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer (PROFILE 1001)
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.
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
Advanced Malignancies (Except Leukemia)
|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|
- 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 ]
- 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.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585195
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|