NCT04627961

A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma

A Phase 2 Trial of TAS 102 in Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Nasopharyngeal Carcinoma
• Recurrent Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	TAS-102	Eligible patients who consent to participate will receive oral TAS-102 bid for days 1-5 and 8-12 of a 28 day cycle.

Timeline

• Start date: 2020-08-26
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: Singapore