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PF-00299804 As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00818441
First received: January 5, 2009
Last updated: May 6, 2013
Last verified: May 2013
History of Changes

January 5, 2009
May 6, 2013
March 2009
April 2012   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort A] PFS is defined as the interval from enrollment to date of objective progression or death due to any cause. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Progression-Free survival at 4 months (PFS4m) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00818441 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort B] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • --Duration of Response (DR) per cohort [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) per cohort [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) per cohort [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall safety profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes of health related quality of life and disease/treatment-related symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Lung Cancer module (LC13) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Trough concentrations of PF-00299804 in blood after repeated dosing [ Time Frame: 10months ] [ Designated as safety issue: No ]
  • Best Overall Response (BOR) per RECIST per cohort [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Best Overall Response (BOR) per RECIST [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall safety profile as characterized by type, frequency, severity as graded by NCI Common Toxicity Criteria for Adverse Events version 3.0 (NCI CTCAEv3.0), timing and relationship to treatment, and laboratory abnormalities observed; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes of health related quality of life and disease/treatment-related symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and its Lung Cancer module [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • (LC13); [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Trough concentrations of PF-00299804 in blood after repeated dosing; and concentrations of PF 00299804 in biofluid (ie, [ Time Frame: 10months ] [ Designated as safety issue: No ]
  • Exploratory endpoints: EGFR and HER signalling pathways in blood and tissue at baseline and on study [ Time Frame: 12 monhts ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
PF-00299804 As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-small Cell
  • Drug: Dacomitinib (PF-00299804)
    Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
  • Drug: Dacomitinib (PF-00299804)
    In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
  • Experimental: Cohort A
    Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
    Intervention: Drug: Dacomitinib (PF-00299804)
  • Experimental: Cohort B
    Dacomitinib in patients with HER2 mutated or amplified NSCLC
    Intervention: Drug: Dacomitinib (PF-00299804)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
114
March 2015
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced adenocarcinoma of lung, measurable disease
  • Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
  • patients with known EGFR activating mutation regardless of smoking status
  • ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

Exclusion Criteria:

  • Active brain metastases
  • Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
  • known EGFR wild type NSCLC
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Hong Kong,   Japan,   Korea, Republic of,   Taiwan
 
NCT00818441
A7471017
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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