Study of Vorinostat and Gefitinib in Relapsed/ or Refractory Patients With Advanced Non-small Cell Carcinoma (NSCLC)
|ClinicalTrials.gov Identifier: NCT01027676|
Recruitment Status : Unknown
Verified November 2013 by Ji-youn Han, National Cancer Center, Korea.
Recruitment status was: Active, not recruiting
First Posted : December 9, 2009
Last Update Posted : November 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Drug: Study treatment||Phase 1 Phase 2|
Phase I design
- Three patients will be treated per cohort for one cycle (28 days per cycle).
- If no DLTs are recorded, treatment will continue and three patients will be treated in the subsequent cohort.
- However, if a patient develops a DLT, another three patients will be treated in this cohort for one cycle.
- If there are no more DLTs, dose escalation continues.
- If more than one of three patients develop a DLT in any cohort, another three patients will be treated in the next lower dosage cohort.
- If no DLTs are recorded in any of the cohorts, cohort 3 will be expanded to six patients.
- Up to 12 patients will be enrolled at the MTD.
- The phase II dose for this combined treatment will be therefore defined as the highest dosage cohort in which six patients had been treated and there are less than three DLTs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Vorinostat and Gefitinib in Relapsed/ or Refractory Patients With Advanced Non-small Cell Carcinoma (NSCLC)|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||March 2014|
Experimental: study arm
single arm Gefitinib plus vorinostat
Drug: Study treatment
Gefitinib 250mg/QD plus vorinostat D1~7 & D15-21 / QD q 4weeks
- Progression-Free Survival [ Time Frame: every 8 weeks ]The first day of treatment to the date that disease progression is reported or death date
- Overall Survival [ Time Frame: every 8 weeks ]The first day of treatment to the date that death is reported or last survival status reported or
- Objective Response rate [ Time Frame: every 8 weeks ]The date of first evaluation to the date of disease progression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027676
|Korea, Republic of|
|National Cancer Center|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||JI-YOUN HAN, M.D.||National Cancer Center|