A Randomized Phase 2 Study of LY2181308 in Combination with Docetaxel versus Docetaxel in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer who Were Previously Treated with First Line Chemotherapy - ND

Active, not recruiting

• Conditions: ocally advanced or metastaic non-small cell lung cancer, second line therapy; MedDRA version: 9.1Level: LLTClassification code 10025054; MedDRA version: 9.1Level: LLTClassification code 10025055

• Registration Number: EUCTR2009-017591-24-IT
• Lead Sponsor: Eli Lilly and Company, Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-12
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1Histological diagnosis of NSCLC with locally advanced or metastatic disease (Stage IIIB or IV at entry)that is not amenable to curative therapy and who have progressed after 1?line of chemotherapy for advanced disease.Pt who received maintenance treatment will be counted as having received 1?line treatment.Pt who received only single-agent EGFR inhibitors as their 1? treatment must have been treated with a chemotherapy regimen prior to be eligible for this study.2Have given written informed consent.3Presence of measurable disease as defined by the RECIST.4The 1?approximately 15 pt on study (pt enrolled prior to the 1?interim analysis) will have a performance status of 0 to 1 on the ECOG Scale.Remaining pt who are enrolled after the 1?interim analysis will have a performance status of 0 to 2 on the ECOG Scale provided that the 1?interim analysis data do not suggest that PS2 pt may not benefit from the regimen.5Must make available any existing tumor tissue from the primary diagnostic biopsy (mandatory).Biopsy material must be sufficient to allow gene expression assessments.If insufficient amount of tissue is found to be available after pt has been randomized,the pt may remain on study without a protocol violations and this pt must be replaced.6The pt must have tumor lesion amenable for a 2?biopsy.This non-mandatory biopsy will be taken before the 1?dose of study drug and may also be obtained from an extra-pulmonary lesion.Cells isolated from pleural effusions will not be used for this study.If biopsy is performed it must provide sufficient material for gene expression assessments.The failure to obtain this biopsy for any reason will not constitute a protocol violation or prevent the pt participation in this study.7Pt with prior radiation therapy are eligible if they meet the following criteria:Previous radiation therapy is allowed to<25% of the bone marrow but whole pelvis radiation is excluded.Prior radiotherapy must be completed at least 2 weeks before pt is randomized.Pt must have recovered from the acute toxic effects of the treatment before randomized.Prior thoracic radiation must be completed 30 days before study enrollment.Irradiated pulmonary lesions cannot be used as target lesions(must be excluded)unless there is previous documented progression of these lesions.Palliative extrathoracic radiotherapy can continue,but these lesions have to be excluded as target lesions.8Pt compliance and geographic proximity that allow for adequate follow-up:Adequate venous access,Absence of any psychological,familial,sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;those conditions should be discussed with the pt before registration in the trial.9Adequate bone marrow reserve and organ function including:Hematologic:neutrophil count>1.5x109/L,platelets>100x109/L,and hemoglobin>9g/dL.Requirements may be met following transfusions.Hepatic: total bilirubin≤1.25xthe ULN,alanine transaminase (ALT) and aspartate transaminase (AST)≤1.5x ULN,alkaline phosphatase≤5xULN.NOTE:ALT and/or AST elevations>1.5xULN are acceptable with asymptomatic or clinically nonrelevant elevation of these isolated transaminases and with total bilirubin≤1.25xULN.Adequate renal function as assessed by serum creatinine≤1.15xULN.In rare cases, pt may enter treatment with a serum creatinine>1.15xULN,<2.0xULN as elevations of serum creatinine may be secondary to dehydration.This re

Exclusion Criteria

12Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. However, patients may be permitted to enter treatment before the 30 day waiting period in special circumstances.13Have previously completed or withdrawn from this study or any other study investigating LY2181308.14Pregnant or breastfeeding (females).15Serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient s ability to complete the study. These conditions include, but are not limited to, unstable angina, pulmonary embolism, uncontrolled hypertension, history of interstitial pneumonitis or pulmonary fibrosis and unmanageable bleeding risks (at the discretion of the investigator). 16Second primary malignancy that could affect compliance with the protocol or interpretation of the study results. For instance, patients with adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, low-grade (Gleason score ≤6) localized prostate cancer and patients with prior history of malignancy who have been diseasefree for more than 3 years are eligible. [17]Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations. 18Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. 19Pre-existing neuropathy equivalent to a CTCAE ≥Grade 2.

Study & Design

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