Non-small-cell lung cancer
Conditions
Interventions
A cohort of three patients will be treated at each dose level for one cycle (28 days per cycle). Treatment will be continued if no DLTs are recorded, and three patients will be treated at the next h
Sponsors
Cancer Research Center, Kanazawa University
Nagoya University Hospital Tohoku University Hospital Shizuoka Cancer Center Institute of Biomedical Research and Innovation Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically diagnosed NSCLC (excluding squamous cell carcinoma) 3)EGFR mutations (deletion of exon 19 and L858R mutation of exon 21) for which the clinical benefits of an EGFR-TKI (gefitinib or erlotinib) are recognized by testing methods that are listed by the national health insurance 4)Having a history of treatment with an EGFR-TKI (gefitinib or erlotinib) and a history of pathology deterioration during treatment 6)Confirmed BIM polymorphism by the PCR fragment analytical method and the sequence method at the central laboratory 7)Having a lesion measureable according to the RECIST guidelines revised version 1.1 (20 mm or larger in 10-mm slice CT, 10 mm or larger in 5-mm slice CT, 15 mm or larger in the minor axis of a lymph node). Confirmed advance of the pathology at the site of irradiation after irradiation in a patient who only has an irradiated lesion 8)Ages 20 years and older 9)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 at the time of consent acquisition
Exclusion criteria
Exclusion criteria: Within 4 weeks after the final administration of a cytotoxic anticancer agent.Allowable enrollment when a 7-day washout is completed after the final administration of an EGFR-TKI. Surgery of a primary tumor or to the mediastinum must be completed at least 6 months before the onset of protocol treatment. Radiotherapy to the lungs considered necessary at the time of study entry or in the near future. Having an interstitial lung disease (including acute pulmonary disorder, interstitial pneumonia, and drug inducibility) or having a history thereof. Having radiation pneumonitis or having a history thereof. Having a large volume of or uncontrollable pleural effusion, ascites, or pericardial effusion Detection of known EGFR-TKI resistance acquired by mutations of the genes, e.g., T790M. Suffering from a severe or poorly controlled systemic disease (e.g., unstable or decompensated respiratory disease, heart disease, renal disease, and liver disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD (Maximum Tolerated Dose) defined as the highest dose level at which 2 of 6 patients experienced a DLT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Safety (adverse events generated in from therapy start to the end of dosage end 30th of vorinostat 2)Blood concetnration after administration of vorinostat and gefitinib 3)progression free survival (PFS) period 4)Overall survival (OS) rate 5)Response rate (PR) 6)A response period and complete response period 7)Disease control rate (DCR) 8)Pharmacodynamic effect | — |
Countries
Japan
Contacts
Public ContactShinji Takeuchi
Cancer Research Center, Kanazawa UNIversity Medical Oncology
Outcome results
None listed