Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
NCT00553254
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- Advanced NSCLC
- Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib
- Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment
- Measurable disease
- Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of
baseline disease assessment
- Patients who lack of tolerance of erlotinib therapy
- Patients with known brain Metastases
- Patients with demonstrated history of or presence of interstitial lung disease.
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Descriptive Information | |||||||
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Brief Title ICMJE | Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer | ||||||
Official Title ICMJE | A PHASE 1/2, OPEN-LABEL, SINGLE ARM TRIAL TO DETERMINE THE RECOMMENDED PHASE 2 DOSE AND EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS IN KOREA WITH KRAS WILD TYPE ADVANCED NSCLC, WHICH IS REFRACTORY TO CHEMOTHERAPY AND ERLOTINIB OR GEFITINIB | ||||||
Brief Summary | To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Carcinoma, Non Small Cell Lung | ||||||
Intervention ICMJE | Drug: PF-00299804
Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent | ||||||
Study Arms ICMJE | Experimental: 1
Intervention: Drug: PF-00299804 | ||||||
Publications * | Park K, Cho BC, Kim DW, Ahn MJ, Lee SY, Gernhardt D, Taylor I, Campbell AK, Zhang H, Giri N, Letrent SP, O'Connell J, Heo DS. Safety and efficacy of dacomitinib in korean patients with KRAS wild-type advanced non-small-cell lung cancer refractory to chemotherapy and erlotinib or gefitinib: a phase I/II trial. J Thorac Oncol. 2014 Oct;9(10):1523-31. doi: 10.1097/JTO.0000000000000275. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 55 | ||||||
Original Enrollment ICMJE | 80 | ||||||
Actual Study Completion Date ICMJE | July 17, 2014 | ||||||
Actual Primary Completion Date | August 3, 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Korea, Republic of | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00553254 | ||||||
Other Study ID Numbers ICMJE | A7471003 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |