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

Completed · Phase 2

Conditions studied: Advanced Non-small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT01101334

Run by

Daiichi Sankyo

People needed

90

Starts

2010-03-01

Expected to finish

2013-04-01

Last updated by the study team

2020-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• DHHA — Denver, Colorado, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Providence Regional Medical Center Everett — Everett, Washington, United States
• Zentrum fur Pneumologie und Thoraxchirurgie — Gauting, Germany
• King George Hospital — Visakhapatnam, Andhra Pradesh, India
• Vedanta Institute of Medical Sciences — Ahmedabad, Gujarat, India
• Kodlikeri Memorial Hospital — Aurangabad, Maharashtra, India
• Tata Memorial Hospital — Mumbai, Maharashtra, India
• Noble Hospital — Pune, Maharashtra, India
• Apollo Speciality Hospital — Chennai, Tamil Nadu, India
• Meenakshi Mission Hospital — Madurai, Tamil Nadu, India
• Orchid Nursing Home — Kolkata, West Bengal, India
• St. Vincent's Hospital — Gyeonggi-do, South Korea
• Hwasun Hospital — Jeonnam, South Korea
• Severance Hospital — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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