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Phase 1/2, Open-Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without PF-02341066 In Patients With Advanced Non-Small Cell Adenocarcinoma Of The Lung


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Phase 1/2, Open-Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without PF-02341066 In Patients With Advanced Non-Small Cell Adenocarcinoma Of The Lung


Inclusion Criteria:



- histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally
advanced or metastatic and of the adenocarcinoma subtype (including mixed
adenosquamous histology)

- evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST)
after at least one but no more than 2 chemotherapy regimens for advanced disease

- tumors must have measurable disease as per RECIST

Exclusion Criteria:

- known interstitial lung disease

- prior treatment with an agent that is known or proposed to be active by action on
EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Dose-Limiting Toxicities (DLT)

Outcome Description:

Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).

Outcome Time Frame:

Baseline up to Day 28

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8081002

NCT ID:

NCT00965731

Start Date:

January 2010

Completion Date:

October 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Neoplasms
  • Crizotinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteColumbia, Missouri  65201