Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01341834
Status:
UNKNOWN
Last Update Posted:
2018-04-24
First Post:
2011-04-21
Brief Title:
Safety and Tolerability Study of RAD001 and LBH589 in All Solid Tumors With Enrichment for EBV Driven Tumors
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Centre Singapore
Study Overview
Official Title:
A Safety and Tolerability Study of RAD001 mTOR Inhibitor in Combination With Two Dosing Schedules of LBH589B Histone Deacetylase Inhibitor in Solid Tumors Lymphomas With Enrichment for EBV-Driven Tumors
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is
1 To determine the optimal recommended phase II dose of two investigational study drugs LBH589 and RAD001 given in combination in all solid tumors With enrichment for EBV-Driven tumors
2 To determine the pharmacokinetic profile of RAD001 in combination with two schedules of LBH589
3 To assess the preliminary anti-tumor activity of RAD001 and LBH589
This study will also be exploring the hypothesis that HDACi and mTOR inhibitors abrogate the effects of key viral proteins and switch the virus from a latent proliferative phase to a lytic phase Immunologic correlates will also be examined to ascertain T-cell subpopulations and expression of HLA class molecules DCE-MRI will be subsequently employed in dose expansion to examine antiangiogenic effects
1 To determine the optimal recommended phase II dose of two investigational study drugs LBH589 and RAD001 given in combination in all solid tumors With enrichment for EBV-Driven tumors
2 To determine the pharmacokinetic profile of RAD001 in combination with two schedules of LBH589
3 To assess the preliminary anti-tumor activity of RAD001 and LBH589
This study will also be exploring the hypothesis that HDACi and mTOR inhibitors abrogate the effects of key viral proteins and switch the virus from a latent proliferative phase to a lytic phase Immunologic correlates will also be examined to ascertain T-cell subpopulations and expression of HLA class molecules DCE-MRI will be subsequently employed in dose expansion to examine antiangiogenic effects
Detailed Description:
Dose escalation phase 1B of the study will evaluate the safety and tolerability of RAD001 in combination with LBH589 in all solid tumors lymphomas and enriched for EBV driven tumors The phase 2 component will be a single arm non-randomized study restricted to nasopharyngeal carinoma only endemic type
A 33 dose escalation design will be adopted Patients will start taking LBH589 three times a week and will have a run in period of one week followed by continous administration of RAD001 from week 2 Pharmacokinetic assessments will be done on day 1 of LBH589 administration and day 1 of concurrent administration of LBH589 RAD001 ON day 31 there will be a one week drug holiday This is done to explore the eliminaition kinetics from steady stateas well as the durability of target modulation
AEs of patients will be monitored closely In the event of grade 34 toxicity the cohort will be expanded to 6 Dose escalation of LBH589RAD001 may proceed until the maximum tolerated dose MTDis reached Once the MTD is established an expasion cohort comprising 20 EBV driven tumors will open at two different LBH589 dose schedules
Treatment will be continued until progression of disease unacceptable toxcity or discontinuation criterion is met
A 33 dose escalation design will be adopted Patients will start taking LBH589 three times a week and will have a run in period of one week followed by continous administration of RAD001 from week 2 Pharmacokinetic assessments will be done on day 1 of LBH589 administration and day 1 of concurrent administration of LBH589 RAD001 ON day 31 there will be a one week drug holiday This is done to explore the eliminaition kinetics from steady stateas well as the durability of target modulation
AEs of patients will be monitored closely In the event of grade 34 toxicity the cohort will be expanded to 6 Dose escalation of LBH589RAD001 may proceed until the maximum tolerated dose MTDis reached Once the MTD is established an expasion cohort comprising 20 EBV driven tumors will open at two different LBH589 dose schedules
Treatment will be continued until progression of disease unacceptable toxcity or discontinuation criterion is met
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None