Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.

The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

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

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Efatutazone; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed stage IIIB or IV NSCLC.

• Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy.

• Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.

• ≥ 18 years of age.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

• Adequate organ and bone marrow function.

• Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 grade ≤ 1.

• Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment.

Exclusion Criteria:

• Treatment with anticancer therapy within 3 weeks before study treatment.

• Therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases).

• Administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment.

• Current need for concomitant use of other TZDs during the study.

• Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening.

• History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction.

• Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.

• Pregnant or breast feeding.

• Prior treatment with epidermal growth factor receptor (EGFR) inhibitors.