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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Participants 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) version 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Must make available any existing tumor tissue from the primary biopsy

• Participants 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 and must not be breastfeeding

• Men must comply with a contraceptive regimen during and for 6 months after the treatment period

Exclusion Criteria:

• Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Participants 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 participant or the participant'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

• Participants 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