Non-small-cell lung cancer
Conditions
Interventions
Patients with previously EGFR-TKI treated refractory NSCLC received fix dose of erlotinib (150mg QD) in combination with escalating doses of YM155 (3.6, 4.8, 6.0 and 8.0 mg/m2/d) administered as a con
Sponsors
Department of Medical Oncology, Kindai University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The main eligibility criteria were as follows A histologically or cytologically confirmed recurrent or metastatic NSCLC patients with documented EGFR exon19 deletion or exon21point mutation who had refractory to EGFR-TKI therapy Patients must have been >20 years of age with anticipated life expectancy of >12 weeks ECOG performance status of 0-2 Adequate hematologic, hepatic, and renal functions No ECG abnormality which needs treatment
Exclusion criteria
Exclusion criteria: The exclusion criteria included the administration of chemotherapy, radiotherapy, or biological therapy in the 4 weeks, 2 weeks for palliative radiotherapy and kinase inhibitors prior to enrollment Other active malignancies; history or presence of interstitial lung disease; presence of symptomatic brain metastasis; history within 6 months before enrollment or presence of severe cardiovascular or cerebrovascular disease, pulmonary thrombosis, deep vein thrombosis, or other clinically severe pulmonary disease; any of the following complications, including clinically severe infections requiring systemic administration of an antimicrobial agent, antiviral agent or other agents; presence of chronic diarrhea, inflammatory bowel disease or partial ileus; presence of peptic ulcer; fluid retention requiring treatment; uncontrolled diabetes mellitus/hypertension; psychiatric symptoms; appositive test for hepatitis B virus surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: - To evaluate the safety and tolerability of YM155 in combination with erlotinib - To determine DLTs and MTD | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Pharmacokinetics (PK) of YM155/erlotinib - Preliminary efficacy - To explore biomarkers analysis including; 1) changes of expression of survivin (IHC) at pre and post administration of YM155 , 2) Survivin RT-PCR, 3)Next generation sequencing (NGS) and 4) Luminex analysis of serum proteins | — |
Countries
Japan
Contacts
Public ContactMasayuki Takeda, M.D., PhD.
Kindai University Faculty of Medicine Department of Medical Oncology
Outcome results
None listed