Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-04 @ 3:10 PM
Study NCT ID:
NCT04627961
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma
Sponsor:
National University Hospital, Singapore
Organization:
Study Overview
Official Title:
A Phase 2 Trial of TAS 102 in Recurrent/Metastatic Nasopharyngeal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
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:
This is a single-arm, non-randomised study including patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease not amenable to curative treatment, who have received at least 1 regimen of platinum containing chemotherapy.
Detailed Description:
HYPOTHESIS
Given the favourable activity of fluoropyrimidines (5Fluorouracil) which inhibit thymidylate synthase (TS) in nasopharyngeal carcinoma, the investigators hypothesized that TAS-102 may demonstrate efficacy in NPC through targeting TS as well as an additional mechanism of incorporating trifluridine triphosphate into DNA.
OBJECTIVES OF TRIAL
1. To determine the clinical efficacy of TAS-102 in recurrent and metastatic NPC
2. To assess the safety and tolerability of TAS-102 in the study population of R/M NPC
3. To study the pharmacokinetics of TAS-102 in the study population of R/M NPC
4. To study potential predictive biomarkers for clinical benefit from TAS-102
Given the favourable activity of fluoropyrimidines (5Fluorouracil) which inhibit thymidylate synthase (TS) in nasopharyngeal carcinoma, the investigators hypothesized that TAS-102 may demonstrate efficacy in NPC through targeting TS as well as an additional mechanism of incorporating trifluridine triphosphate into DNA.
OBJECTIVES OF TRIAL
1. To determine the clinical efficacy of TAS-102 in recurrent and metastatic NPC
2. To assess the safety and tolerability of TAS-102 in the study population of R/M NPC
3. To study the pharmacokinetics of TAS-102 in the study population of R/M NPC
4. To study potential predictive biomarkers for clinical benefit from TAS-102
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: