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Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Seoul, , 110-744 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00553254
Pfizer
Completed
Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

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Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
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
To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non Small Cell Lung
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
Experimental: 1
Intervention: Drug: PF-00299804
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.
 
Completed
55
July 2014
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00553254
A7471003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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