Dacomitinib (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: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-small Cell
Drug: Dacomitinib (PF-00299804)
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 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]
    The period from study entry until disease progression, death or date of last contact.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort B] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact.

  • --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 ]

Enrollment: 119
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
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).
Experimental: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818441

  Show 66 Study Locations
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: NCT00818441     History of Changes
Other Study ID Numbers: A7471017
Study First Received: January 5, 2009
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
lung cancer adenocarcinoma HER2

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 22, 2014