Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer

NCT ID: NCT00067548

Last Updated: 2009-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-01-31

Brief Summary

This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens.

The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. Secondary objectives include:

• To further evaluate the safety of EKB-569
• To explore additional clinical activity parameters
• To explore subject survival
• To evaluate the pharmacokinetics of EKB-569
• To assess subject reported outcomes

EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.

Conditions

Non-Small-Cell Lung Carcinoma; Carcinoma, Non-Small Cell Lung; Lung Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

EKB-569

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
• Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy

Exclusion Criteria

• Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas)
• Prior radiotherapy to >25% of bone marrow
• Prior epidermal growth factor receptor-targeting therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

3095A1-201

Identifier Type: -

Identifier Source: org_study_id