Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-05

Study Completion Date

2014-07-17

Brief Summary

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To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.

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Detailed Description

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Conditions

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Carcinoma, Non Small Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent

Interventions

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PF-00299804

Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No