Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

Phase 1

• Conditions: ocally Advanced or Metastatic Non-Small Cell Lung Cancer; MedDRA version: 14.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-017591-24-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

•Patients with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
•Measureable disease as defined by response evaluation criteria in solid tumors (RECIST)
•ECOG Performance status of 0 to 1
•Must make available any existing tumor tissue from the primary biopsy
•Patients with prior radiation may be eligible if they meet certain criteria
•Adequate bone marrow reserve and organ functioning
•Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period. Must not be breastfeeding
•Men must comply with a contraceptive regimen during and for 6 months after the treatment period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Patients may be permitted to enter treatment before the 30 day waiting period in special circumstances
•Pregnant or breastfeeding
•Serious concomitant systemic disorders that would compromise the safety of the patient or the patient's ability to complete the study
•Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
•Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
•Patients with documented central nervous system or brain metastasis at the time of study entry
•Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified