Phase I of Vorinostat-Iressa combined therapy on resistance by BIM polymorphysim in EGFR Mutant Lung Cancer
- Conditions
- on-small-cell lung cancer
- Registration Number
- JPRN-UMIN000015193
- Lead Sponsor
- Cancer Research Center, Kanazawa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Not provided
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MTD (Maximum Tolerated Dose) defined as the highest dose level at which 2 of 6 patients experienced a DLT.
- Secondary Outcome Measures
Name Time Method 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