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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553254
Recruitment Status : Completed
First Posted : November 5, 2007
Last Update Posted : August 8, 2014
Information provided by (Responsible Party):

Brief Summary:
To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Non Small Cell Lung Drug: PF-00299804 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 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

Primary Outcome Measures :
  1. Endpoints- Phase 1- Recommended phase 2 dose. [ Time Frame: 30-AUG-2008 ]
  2. Phase 2- Progression -free survival at 4 months [ Time Frame: 26-JUL-2010 ]

Secondary Outcome Measures :
  1. Overall response according to Response Evaluation Criteria in Solid Tumors. [ Time Frame: 30-JAN-2010 ]
  2. Overall survival at 6 months [ Time Frame: 26-JUL-2010 ]
  3. Safety profile as characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed. [ Time Frame: 26-JUL-2010 ]
  4. Phase 1- Single and multiple dose pharmacokinetic parameters of PF_00299804 [ Time Frame: 30-MAR-2009 ]
  5. Phase 2-Duration of overall response [ Time Frame: 26-JUL-2010 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553254

Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00553254     History of Changes
Other Study ID Numbers: A7471003
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases