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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00553254
First received: November 2, 2007
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoints- Phase 1- Recommended phase 2 dose. [ Time Frame: 30-AUG-2008 ] [ Designated as safety issue: Yes ]
  • Phase 2- Progression -free survival at 4 months [ Time Frame: 26-JUL-2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response according to Response Evaluation Criteria in Solid Tumors. [ Time Frame: 30-JAN-2010 ] [ Designated as safety issue: No ]
  • Overall survival at 6 months [ Time Frame: 26-JUL-2010 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Phase 1- Single and multiple dose pharmacokinetic parameters of PF_00299804 [ Time Frame: 30-MAR-2009 ] [ Designated as safety issue: No ]
  • Phase 2-Duration of overall response [ Time Frame: 26-JUL-2010 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: February 2008
Study Completion Date: July 2014
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553254

Locations
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00553254     History of Changes
Other Study ID Numbers: A7471003
Study First Received: November 2, 2007
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014