A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00769067
First received: October 7, 2008
Last updated: September 7, 2014
Last verified: September 2014

October 7, 2008
September 7, 2014
November 2008
October 2010   (final data collection date for primary outcome measure)
Progression- Free Survival for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769067 on ClinicalTrials.gov Archive Site
  • Overall safety profile for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes (PRO) of health related quality of life and disease/treatment related symptoms for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • KRAS and HER family mutations in circulating tumor DNA in blood and in tissue (from original diagnostic or recently obtained sample) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Best Overall Response per RECIST (BOR) for patients in each arm [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Duration of Response for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Overall Survival for patients in each arm [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Pre and post treatment levels of circulating shed receptors of the HER signaling pathways or protein/receptors which interact with or are part of HER signaling pathway [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • EGFR mutations, including T790M, in blood at baseline and at end of study [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Trough concentrations of PF 00299804 after repeated dosing; [ Time Frame: 13months ] [ Designated as safety issue: No ]
  • Trough concentrations of PF 00299804 after repeated dosing; [ Time Frame: 13months ] [ Designated as safety issue: No ]
  • Overall safety profile for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes (PRO) of health related quality of life and disease/treatment related symptoms for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • KRAS and HER family mutations in circulating tumor DNA in blood and in tissue (from original diagnostic or recently obtained sample) [ Time Frame: 16 monhts ] [ Designated as safety issue: No ]
  • Best Overall Response per RECIST (BOR) for patients in each arm [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Duration of Response for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Overall Survival for patients in each arm [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Pre and post treatment levels of circulating shed receptors of the HER signaling pathways or protein/receptors which interact with or are part of HER signaling pathway [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • EGFR mutations, including T790M, in blood at baseline and at end of study [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
A Randomized Phase 2 Trial Of PF-00299804 Versus Erlotinib For The Treatment Of Advanced Non Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Erlotinib
    Continuous oral dosing at 150 mg daily.
  • Drug: PF-00299804
    Continuous oral dosing at 45mg daily
  • Active Comparator: A
    Intervention: Drug: Erlotinib
  • Experimental: B
    Intervention: Drug: PF-00299804
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
August 2014
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • advanced measurable Non-Small Cell Lung Cancer (NSCLC);
  • progressed after 1-2 prior chemotherapy;
  • Eastern Cooperative Oncology Group (ECOG) 0-2;
  • tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

  • prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
  • active or untreated Central Nervous System (CNS) metastases;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Hong Kong,   Korea, Republic of,   Poland,   Puerto Rico,   Singapore,   Spain,   Taiwan,   United Kingdom
 
NCT00769067
A7471028
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP