PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB
1 other identifier
interventional
66
1 country
19
Brief Summary
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Typical duration for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2007
CompletedFirst Posted
Study publicly available on registry
October 23, 2007
CompletedStudy Start
First participant enrolled
April 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2012
CompletedResults Posted
Study results publicly available
May 21, 2019
CompletedMay 21, 2019
May 1, 2019
1.9 years
October 19, 2007
February 7, 2019
May 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response (BOR) in Participants With Adenocarcinoma Histology
BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: disappearance of all lesions. Partial Response (PR):greater than or equal to (\>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \>=1 new lesion. Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Secondary Outcomes (13)
Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology
Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Duration of Response (DR)
Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Percent Probability of Progression-free Survival (PFS) at Month 6
Up to 6 months after the start of study medication
Percent Probability of Overall Survival at Months 6 and 12
Months 6, 12
Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)]
0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
- +8 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALdescriptive: adenocarcinoma histology
2
EXPERIMENTALdescriptive: non-adenocarcinoma histology
Interventions
Eligibility Criteria
You may qualify if:
- Advanced Non-Small Cell Lung Cancer (NSCLC)
- Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
- Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
- Measurable disease .
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Tissue available for KRAS/ EGFR testing
- Creatinine clearance \> 40 cc/min or serum creat \< 1.5 x ULN
You may not qualify if:
- Chemotherapy
- Radiotherapy
- Biological or investigational agents within 4 weeks of baseline disease assessment.
- Patients who lack of tolerance of erlotinib therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (19)
City of Hope
Duarte, California, 91010, United States
City of Hope Medical Group
Pasadena, California, 91105, United States
City of Hope South Pasadena Cancer Center
South Pasadena, California, 91030, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045, United States
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
University of Colorado Hospital, Anschutz Inpatient Pavilion
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Grady Health Systems
Atlanta, Georgia, 30303, United States
Emery University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
CCR, National Cancer Institute
Bethesda, Maryland, 20892, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute/Wayne State University
Detroit, Michigan, 48201, United States
Lawrence and Idell Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Related Publications (1)
Reckamp KL, Giaccone G, Camidge DR, Gadgeel SM, Khuri FR, Engelman JA, Koczywas M, Rajan A, Campbell AK, Gernhardt D, Ruiz-Garcia A, Letrent S, Liang J, Taylor I, O'Connell JP, Janne PA. A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib. Cancer. 2014 Apr 15;120(8):1145-54. doi: 10.1002/cncr.28561. Epub 2014 Feb 5.
PMID: 24501009DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Results for PK parameters to be assessed using nonlinear mixed effects modelling (NONMEM) are not provided because of change in planned analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2007
First Posted
October 23, 2007
Study Start
April 29, 2008
Primary Completion
March 16, 2010
Study Completion
June 11, 2012
Last Updated
May 21, 2019
Results First Posted
May 21, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share
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: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.