A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer (PROFILE 1001)
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|ClinicalTrials.gov Identifier: NCT00585195|
Recruitment Status : Active, not recruiting
First Posted : January 3, 2008
Last Update Posted : October 1, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||596 participants|
|Masking:||None (Open Label)|
|Official Title:||PHASE 1 SAFETY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF PF-02341066, A MET/HGFR SELECTIVE TYROSINE KINASE INHIBITOR, ADMINISTERED ORALLY TO PATIENTS WITH ADVANCED CANCER|
|Actual Study Start Date :||April 19, 2006|
|Actual Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||December 31, 2022|
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).
600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.
Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.
- 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.
- 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.
- Maximum tolerated dose (MTD) [ Time Frame: 2.5 years ]
- 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).
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00585195
|Study Director:||Pfizer CT.gov Call Center||Pfizer|