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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01121575




Registration number
NCT01121575
Ethics application status
Date submitted
10/05/2010
Date registered
12/05/2010
Date last updated
28/10/2015

Titles & IDs
Public title
A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer
Scientific title
A Phase 1, Open-label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of Combined Oral C-met/Alk Inhibitor (Pf-02341066) And Pan-her Inhibitor (Pf-00299804) In Patients With Advanced Non-small Cell Lung Cancer
Secondary ID [1] 0 0
A8081006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-02341066
Treatment: Drugs - PF-00299804
Treatment: Drugs - PF-02341066
Treatment: Drugs - PF-00299804

Experimental: Arm 1 - PF-02341066 AND PF-00299804: Patients will be treated with combined cMET inhibitor (PF-02341066) and panHER inhibitor (PF-00299804).

Experimental: Arm 2 - PF-00299804 FOLLOWED BY COMBINED PF-02341066 AND PF-00299804: Patients will be treated with single agent panHER inhibitor (PF-00299804) until disease progression and then with the maximum tolerated combined dose of cMET inhibitor (PF-02341066) and panHER inhibitor (PF-00299804).


Treatment: Drugs: PF-02341066
Arm 1: The starting dose will be 200 mg by mouth, twice a day of PF 02341066 in tablet form The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.

Treatment: Drugs: PF-00299804
Arm 1: The starting dose will be 30 mg by mouth once a day of PF-0029804 in tablet form. The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.

Treatment: Drugs: PF-02341066
Arm 2: With progressive disease the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).

Treatment: Drugs: PF-00299804
Arm 2: The dose of 45 mg by mouth once a day of PF-00299804 in tablet form until progressive disease and then the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase
Timepoint [1] 0 0
Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)
Primary outcome [2] 0 0
Overview of Treatment-emergent All Causalities AEs in Expansion Phase
Timepoint [2] 0 0
Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)
Primary outcome [3] 0 0
Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase
Timepoint [3] 0 0
Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)
Primary outcome [4] 0 0
Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase
Timepoint [4] 0 0
Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)
Primary outcome [5] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase
Timepoint [5] 0 0
Cycle 1 (4 weeks)
Secondary outcome [1] 0 0
Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase
Timepoint [1] 0 0
From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)
Secondary outcome [2] 0 0
Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase
Timepoint [2] 0 0
From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)
Secondary outcome [3] 0 0
Number of Participants With Objective Response Rate (ORR) in Escalation Phase
Timepoint [3] 0 0
From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)
Secondary outcome [4] 0 0
Number of Participants With ORR in Expansion Phase
Timepoint [4] 0 0
From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)
Secondary outcome [5] 0 0
Duration of Response for the Only Participant Shown Partial Response in Expansion Phase
Timepoint [5] 0 0
From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)
Secondary outcome [6] 0 0
Progression Free Survival (PFS) in Escalation Phase
Timepoint [6] 0 0
From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)
Secondary outcome [7] 0 0
Progression Free Survival (PFS) in Expansion Phase
Timepoint [7] 0 0
From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)
Secondary outcome [8] 0 0
Expression Analysis of Tumor Biomarkers (HGF, EGFR, and c-Met ) at Baseline Using Immunohistochemistry (IHC) Method
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Expression Analysis of Tumor Biomarkers (EGFR, and c-Met) at Baseline Using Fluorescent in Situ Hybridization (FISH) Method
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Number of Participants With c-Met, HER2, EGFR Amplification and ALK Rearrangement at Baseline Using FISH Method
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Plasma Concentration of sMet by Study Visits
Timepoint [11] 0 0
At screening and Cycle 1 Day 1 (C1D1) (6 hours post dose), and C1D15, C2D1, C2D15 (all predose).
Secondary outcome [12] 0 0
Number of Participants With EGFR Mutation at Baseline
Timepoint [12] 0 0
Baseline
Secondary outcome [13] 0 0
Number of Participants With KRAS Mutation (GLY12CYS) at Baseline
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Number of Participants With PIK3CA Mutation at Baseline
Timepoint [14] 0 0
Baseline
Secondary outcome [15] 0 0
Number of Participants With ROS1 Gene Translocation at Baseline
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Concentration (AUClast)
Timepoint [16] 0 0
Cycle 1 (C1)/Day 1 (D1), C1D15
Secondary outcome [17] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Curve 10 (AUC10)
Timepoint [17] 0 0
C1D1, C1D15
Secondary outcome [18] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Maximum Plasma Concentration (Cmax)
Timepoint [18] 0 0
C1D1, C1D15
Secondary outcome [19] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Time of Last Quantifiable Concentration (Tlast)
Timepoint [19] 0 0
C1D1, C1D15
Secondary outcome [20] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase -Time to Maximum Plasma Concentration (Tmax)
Timepoint [20] 0 0
C1D1, C1D15
Secondary outcome [21] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUClast
Timepoint [21] 0 0
C1D1, C1D15
Secondary outcome [22] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUC24
Timepoint [22] 0 0
C1D1, C1D15
Secondary outcome [23] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Cmax
Timepoint [23] 0 0
C1D1, C1D15
Secondary outcome [24] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tlast
Timepoint [24] 0 0
C1D1, C1D15
Secondary outcome [25] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tmax
Timepoint [25] 0 0
C1D1, C1D15
Secondary outcome [26] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUClast
Timepoint [26] 0 0
Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [27] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUC10
Timepoint [27] 0 0
Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [28] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmin
Timepoint [28] 0 0
Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [29] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmax
Timepoint [29] 0 0
Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [30] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tlast
Timepoint [30] 0 0
Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [31] 0 0
Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tmax
Timepoint [31] 0 0
Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [32] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUClast
Timepoint [32] 0 0
Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [33] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUC24
Timepoint [33] 0 0
Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [34] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmin
Timepoint [34] 0 0
Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [35] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmax
Timepoint [35] 0 0
Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [36] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tlast
Timepoint [36] 0 0
Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)
Secondary outcome [37] 0 0
Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tmax
Timepoint [37] 0 0
Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)

Eligibility
Key inclusion criteria
* advanced non small cell lung cancer (dose escalation phase)
* acquired resistance to erlotinib or gefitinib (expansion phase)
* mandatory entrance biopsy (expansion phase)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* interstitial lung disease
* unstable brain metastases
* leptomeningeal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01121575