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A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-small Cell

Thank you

Trial Information

A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

10 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A7471017

NCT ID:

NCT00818441

Start Date:

March 2009

Completion Date:

March 2015

Related Keywords:

  • Carcinoma, Non-Small Cell
  • lung cancer adenocarcinoma HER2
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteBismarck, North Dakota  58503