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

NCT01101334 | Completed Phase 2 Results

• 1 other identifier: CS7017-A-U204
• Study Type: interventional
• Target: 90
• Locations: 4 countries
• Sites: 17

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)

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

  Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.

  Baseline to disease progression or death, up to approximately 2.5 years

Secondary Outcomes (3)

• Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

  Baseline to death, up to approximately 2.5 years

• Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

  Baseline to disease progression or death, up to approximately 2.5 years

• Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

  Baseline to 30 days after last dose, up to approximately 2.5 years

Study Arms (2)

CS-7017 plus erlotinib

EXPERIMENTAL

Drug: CS-7017; Drug: erlotinib

erlotinib

ACTIVE COMPARATOR

Drug: erlotinib

Interventions

CS-7017 DRUG

CS-7017, Two 0.25mg Tablets administered twice daily

CS-7017 plus erlotinib

erlotinib DRUG

Erlotinib; One 150mg tablet administered once daily

Also known as: Tarceva

CS-7017 plus erlotinib; erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (17)

DHHA

Denver, Colorado, 80204, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Zentrum fur Pneumologie und Thoraxchirurgie

Gauting, D-82131, Germany

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Vedanta Institute of Medical Sciences

Ahmedabad, Gujarat, 380009, India

Location

Kodlikeri Memorial Hospital

Aurangabad, Maharashtra, 431001, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Noble Hospital

Pune, Maharashtra, 411 013, India

Location

Apollo Speciality Hospital

Chennai, Tamil Nadu, 600 035, India

Location

Meenakshi Mission Hospital

Madurai, Tamil Nadu, 625107, India

Location

Orchid Nursing Home

Kolkata, West Bengal, 700 054, India

Location

St. Vincent's Hospital

Gyeonggi-do, 442-723, South Korea

Location

Hwasun Hospital

Jeonnam, 519-763, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

efatutazone; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

IN (8); US (3); DE (1); KR (5)