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A Phase 1/2, Open Label, Single Arm Trial To Determine The Recommended Phase 2 Dose And Evaluate The Efficacy Of Pf 00299804 In Patients In Korea With Kras Wild Type Advanced NSCLC, Which Is Refractory To Chemotherapy And Erlotinib Or Gefitinib


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

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Trial Information

A Phase 1/2, Open Label, Single Arm Trial To Determine The Recommended Phase 2 Dose And Evaluate The Efficacy Of Pf 00299804 In Patients In Korea With Kras Wild Type Advanced NSCLC, Which Is Refractory To Chemotherapy And Erlotinib Or Gefitinib


Inclusion Criteria:



- Advanced NSCLC

- Prior treatment with and failure of at least one regimen of chemotherapy and
erlotinib or gefitinib

- Prior treatment with no more than two chemotherapy regimens, including adjuvant
treatment

- Measurable disease

Exclusion Criteria:

- Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of
baseline disease assessment

- Patients who lack of tolerance of erlotinib therapy

- Patients with known brain Metastases

- Patients with demonstrated history of or presence of interstitial lung disease.

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:

Endpoints- Phase 1- Recommended phase 2 dose.

Outcome Time Frame:

30-AUG-2008

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:

A7471003

NCT ID:

NCT00553254

Start Date:

February 2008

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Non Small Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

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