A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: ARGX-110

• Registration Number: NCT02759250
• Lead Sponsor: argenx

Brief Summary

To characterize the safety profile of ARGX-110 administered as mono- or combination therapy to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-03
• Primary Completion: 2018-04-25
• Study Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adjuvant monotherapy	ARGX-110	ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles
metastatic/recurrent monotherapy	ARGX-110	ARGX-110 5mg/kg once every three weeks until disease progression
metastatic/recurrent combination therapy	ARGX-110	ARGX-110 5mg/kg once every three weeks plus chemotherapy until disease progression. The choice of the chemotherapy agents is limited to: cisplatin, carboplatin, 5-fluorouracil, gemcitabine and paclitaxel.

Primary Outcome Measures

Name	Time	Method
Incidence and grading of AEs	measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378	Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of ARGX110 by Cmax	measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378	Change from baseline in Measurement of drug concentration in the blood
Biomarkers CD70 immunohistochemistry (IHC)	measured at Screening, Day 42, and thereafter every 42 days until day Day 378	Change in Measurement of concentration in tumor tissue
Pharmacokinetic profile of ARGX110 by AUC	measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378	Change in Measurement of drug concentration in the blood

Trial Locations

Locations (1)

UZG - Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium