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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00585195




Registration number
NCT00585195
Ethics application status
Date submitted
29/12/2007
Date registered
3/01/2008
Date last updated
17/06/2020

Titles & IDs
Public title
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
Scientific 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
Secondary ID [1] 0 0
PROFILE 1001
Secondary ID [2] 0 0
A8081001
Universal Trial Number (UTN)
Trial acronym
PROFILE 1001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer ALK-positive 0 0
Non-Small Cell Lung Cancer c-Met Dependent 0 0
Non-Small Cell Lung Cancer ROS Marker Positive 0 0
Systemic Anaplastic Large-Cell Lymphoma 0 0
Advanced Malignancies Except Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-02341066
Treatment: Drugs - Rifampin
Treatment: Drugs - Itraconazole

Experimental: 1 -


Treatment: Drugs: 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).

Treatment: Drugs: Rifampin
600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - 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.
Timepoint [1] 0 0
2.5 years
Primary outcome [2] 0 0
Area under the Concentration-Time Curve (AUC) - AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Timepoint [2] 0 0
2.0 years
Primary outcome [3] 0 0
Maximum tolerated dose (MTD)
Timepoint [3] 0 0
2.5 years
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response - 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).
Timepoint [1] 0 0
4.0 years
Secondary outcome [2] 0 0
Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with rifampin - AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Timepoint [2] 0 0
2.0 years
Secondary outcome [3] 0 0
Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with itraconazole - AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Timepoint [3] 0 0
3.0 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Vermont
Country [12] 0 0
Japan
State/province [12] 0 0
Aichi
Country [13] 0 0
Japan
State/province [13] 0 0
Hyogo
Country [14] 0 0
Japan
State/province [14] 0 0
Osaka
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00585195
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications