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

NCT ID: NCT01101334

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-04-30

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.

Conditions

Advanced Non-small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CS-7017 plus erlotinib

Group Type: EXPERIMENTAL

CS-7017

Intervention Type: DRUG

CS-7017, Two 0.25mg Tablets administered twice daily

erlotinib

Intervention Type: DRUG

Erlotinib; One 150mg tablet administered once daily

erlotinib

Group Type: ACTIVE_COMPARATOR

erlotinib

Intervention Type: DRUG

Erlotinib; One 150mg tablet administered once daily

Interventions

CS-7017

CS-7017, Two 0.25mg Tablets administered twice daily

Intervention Type: DRUG

erlotinib

Erlotinib; One 150mg tablet administered once daily

Intervention Type: DRUG

Other Intervention Names

Tarceva

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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

Countries

United States; Germany; India; South Korea

Other Identifiers

CS7017-A-U204

Identifier Type: -

Identifier Source: org_study_id