Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Jun 16, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Daiichi Sankyo
- Interventions being studied
- Drug: CS-7017; Drug: erlotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- DHHADenver, Colorado
- Gabrail Cancer CenterCanton, Ohio
- Providence Regional Medical Center EverettEverett, Washington
- Zentrum fur Pneumologie und ThoraxchirurgieGauting
- King George HospitalVisakhapatnam, Andhra Pradesh
- Vedanta Institute of Medical SciencesAhmedabad, Gujarat
- Kodlikeri Memorial HospitalAurangabad, Maharashtra
- Tata Memorial HospitalMumbai, Maharashtra
- Noble HospitalPune, Maharashtra
- Apollo Speciality HospitalChennai, Tamil Nadu
- Meenakshi Mission HospitalMadurai, Tamil Nadu
- Orchid Nursing HomeKolkata, West Bengal
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 16, 2020. Always confirm current availability with the study team.