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CompletedPhase 2NCT01101334
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCS-7017 and erlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 16, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?Daiichi Sankyo

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Daiichi Sankyo
Interventions being studied
Drug: CS-7017; Drug: erlotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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