NCT01101334
Completed
Phase 2
Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Enrollment
- 90
- Locations
- 17
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •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 ≤
- •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.
Arms & Interventions
CS-7017 plus erlotinib
Experimental
Intervention: CS-7017 (Drug)
CS-7017 plus erlotinib
Experimental
Intervention: erlotinib (Drug)
erlotinib
Active Comparator
Intervention: erlotinib (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Baseline to disease progression or death, up to approximately 2.5 years
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.
Secondary Outcomes
- 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)
Investigators
Study Sites (17)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
A study to help test a study drug called CS-7017 in combination with chemotherapy in patients that have non-small cell lung cancerTreatment of patients with advanced non-small cell lung cancer (NSCLC) after failure of prior chemotherapy regimenMedDRA 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]EUCTR2009-016083-36-DEDaiichi Sankyo Pharma Development90
Completed
Phase 2
This is a multicenter, open-label, two-arm, Phase 2 clinical study and will be conducted in male and female subjects aged 18 years and older with advanced NSCLC who have progressed after first line therapy, to evaluate the safety and efficacy of erlotinib in combination with CS-7017.Health Condition 1: null- Treatment of patients with advanced non-small cell lung cancer (NSCLC) after failure of a prior chemotherapy regimen.CTRI/2010/091/001298Daiichi Sankyo Pharma Development90
Completed
Phase 2
Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell CancerRecurrent Renal Cell CancerStage III Renal Cell CancerStage IV Renal Cell CancerNCT00060307National Cancer Institute (NCI)40
Completed
Phase 2
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung CancerAdenocarcinoma of the LungLarge Cell Lung CancerRecurrent Non-small Cell Lung CancerSquamous Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung CancerNCT00087412National Cancer Institute (NCI)65
Unknown
Phase 2
Efficacy of Erlotinib for Brain Metastasis of Non-Small Cell Lung CancerNon-Small Cell Lung CancerBrain MetastasesNCT00663689Guangdong Provincial People's Hospital45