A study to help test a study drug called CS-7017 in combination with chemotherapy in patients that have non-small cell lung cancer

• Conditions: Treatment of patients with advanced non-small cell lung cancer (NSCLC) after failure of prior chemotherapy regimen; MedDRA version: 14.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-016083-36-DE
• Lead Sponsor: Daiichi Sankyo Pharma Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Subjects must satisfy all of the following criteria to be included in the study:
1. Histologically or cytologically confirmed stage IIIB or IV NSCLC previously treated with a platinum-based regimen.
2. Progressive disease (either no response to treatment or subsequent relapse after an objective response) after the last anti-cancer therapy.
3. Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.
4. = 18 years of age
5. ECOG performance status of 0, 1, or 2.
6. Adequate organ and bone marrow function as assessed by clinical laboratory evaluations:
- Hemoglobin = 9 g/L
- Absolute neutrophil count = 1.5 x 10e9/L
- Platelets = 100 x 10e9 /L
- Serum creatinine <1.5 upper limit of normal (ULN) or calculated
creatinine clearance > 60 mL/min
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase < 2.5 x ULN if liver metastases are absent or = 5.0 x ULN if liver metastases are present
- Total bilirubin =1.5 x ULN
7. Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade = 1 (see Section 17.2).
8. Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. Men who are the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.
9. All female subjects of childbearing potential must have a negative serum or urine pregnancy test result before initiating study treatment.
10. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC- or IRB-approved ICF (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests.
11. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following criteria will be disqualified from entering the study:
1. More than two prior chemotherapy regimens for advanced disease. Maintenance
therapy does not count as a separate regimen, if it is given after first line therapy
without intervening disease progression.
2. Prior treatment with EGFR inhibitors.
3. Treatment with anticancer therapy within 3 weeks before study treatment.
4. Therapeutic or palliative radiation therapy within 2 weeks or major surgery within
4 weeks before study treatment.
5. Prior administration of other TZDs within 4 weeks before study treatment or current need for concomitant use of other TZDs during the study.
6. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms; uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Subjects with treated brain metastases which are no longer symptomatic and require no treatment may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 15 days must have elapsed between the end of radiotherapy and study enrollment.
7. 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.
8. 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.
9. Pericardial effusion or pericardial involvement with the tumor. Clinically significant pleural effusion (ie, requiring drainage). Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
10. History of malignancy other than NCSLC, except adequately treated
non melanoma skin cancer, curatively treated in-situ cancer of the cervix or other
solid tumors curatively treated with no evidence of disease for = 5 years.
11. Previous administration of CS-7017.
12. Pregnant or breast feeding.
13. Serious intercurrent medical or psychiatric illnesses or any other conditions that in
the opinion of the Investigator would impair the ability to give informed consent
or unacceptably reduce protocol compliance or safety of the study treatment.
14. Known hypersensitivity to any of the two study drugs.
15. Subjects currently enrolled in another investigational drug study or within
4 weeks of start of treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the difference in efficacy, as measured by progression-free survival (PFS), between erlotinib in combination with CS-7017 and erlotinib alone.;Secondary Objective: To estimate the overall survival (OS) in the two treatment arms.<br><br>To estimate the overall response rate (ORR) in the two treatment arms.<br><br>To estimate plasma concentration of CS-7017 at scheduled times points.<br><br>To evaluate the safety profile of the combination of CS-7017 and erlotinib relative to that of erlotinib alone.;Primary end point(s): The primary endpoint is PFS.;Timepoint(s) of evaluation of this end point: For progression free survival, we will evaluate whole Kaplan-Meier curve over time, not Kaplan-Meier curve at some specific timepoint.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are OS, ORR, safety endpoints of adverse events (AEs), clinical laboratory evaluations, physical examination findings, and vital sign measurements, and plasma concentrations of CS-7017.;Timepoint(s) of evaluation of this end point: For overall survival, we will evaluate whole Kaplan-Meier curve over time, not Kaplan-Meier curve at some specific timepoint.