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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101334
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : May 23, 2014
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Non-small Cell Lung Cancer Drug: CS-7017 Drug: erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Study Start Date : March 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: CS-7017 plus erlotinib Drug: CS-7017
CS-7017, Two 0.25mg Tablets administered twice daily

Drug: erlotinib
Erlotinib; One 150mg tablet administered once daily
Other Name: Tarceva

Active Comparator: erlotinib Drug: erlotinib
Erlotinib; One 150mg tablet administered once daily
Other Name: Tarceva

Primary Outcome Measures :
  1. proportion of subjects with progression free survival [ Time Frame: 4-12 months ]
    Estimate the difference between the proportion of subjects with progression free survival who are treated with the combination of CS-7017/Erlotinib or Erlotinib alone.

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 4-12 months ]
    estimate the overall survival in both treatment groups

  2. overall response rate [ Time Frame: 4-12 months ]
    estimate the overall response rate for the two treatment groups

  3. plasma concentration of CS-7017 [ Time Frame: week 3 ]
    determine the plasma concentration of CS-7017 at scheduled time points

  4. number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE, and treatment-emergent SAEs. [ Time Frame: 4-12 months ]
    The number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE) will be summarized by treatment, the worst NCI CTCAE grade, system organ class, and preferred term. Similarly the number and percentage of subjects reporting treatment-emergent SAEs will be summarized.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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:

  • No treatment with anticancer therapy within 4 weeks before study treatment.
  • No therapeutic or palliative radiation therapy or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases).
  • No administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment.
  • No current need for concomitant use of other TZDs during the study.
  • No 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.
  • No 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.
  • No pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
  • Neither pregnant nor breast feeding.
  • No known EGFR mutations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01101334

United States, Colorado
Denver, Colorado, United States, 80204
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Washington
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Zentrum fur Pneumologie und Thoraxchirurgie
Gauting, Germany, D-82131
King George Hospital
Visakhapatnam, Andhra Pradesh, India, 530002
Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India, 380009
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, India, 431001
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Noble Hospital
Pune, Maharastra, India, 411 013
Apollo Speciality Hospital
Chennai, Tamil Nadu, India, 600 035
Meenakshi Mission Hospital
Madurai, Tamil Nadu, India, 625107
Orchid Nursing Home
Kolkata, West Bengal, India, 700 054
Korea, Republic of
St. Vincent's Hospital
Gyeonggi-Do, Korea, Republic of, 442-723
Hwasun Hospital
Jeonnam, Korea, Republic of, 519-763
Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT01101334     History of Changes
Other Study ID Numbers: CS7017-A-U204
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Daiichi Sankyo, Inc.:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action