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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01101334
First received: April 7, 2010
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Advanced Non-small Cell Lung Cancer
Drug: CS-7017
Drug: erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • proportion of subjects with progression free survival [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
    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:
  • overall survival [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
    estimate the overall survival in both treatment groups

  • overall response rate [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
    estimate the overall response rate for the two treatment groups

  • plasma concentration of CS-7017 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    determine the plasma concentration of CS-7017 at scheduled time points

  • number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE, and treatment-emergent SAEs. [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101334

Locations
United States, Colorado
DHHA
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
Germany
Zentrum fur Pneumologie und Thoraxchirurgie
Gauting, Germany, D-82131
India
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
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT01101334     History of Changes
Other Study ID Numbers: CS7017-A-U204
Study First Received: April 7, 2010
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
NSCLC

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

ClinicalTrials.gov processed this record on April 14, 2014