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

Cancer Clinical Trial

Official title:

A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759250
• Other study ID #: ARGX-110-1401
• Status: Completed
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: argenx BVBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age =18 years.

• Written informed consent prior to any study-related procedure

• Willing and able to comply with protocol-specified procedures and scheduled evaluations

• Pathological diagnosis of nasopharyngeal carcinoma (NPC)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1or 2

• Absolute neutrophil count (ANC) > 0.5 x 109/L

• Haemoglobin > 80 g/L

• Platelet count = 50 x 109/L

• Total bilirubin = 2 x the upper limit of normal (ULN)

• Alanine transaminase (ALT) = 5 x ULN

• Serum creatinine = 2 x ULN

Exclusion criteria:

• History or clinical evidence of neoplastic central nervous system (CNS) involvement. Note: Irradiated brain metastases that have been stable for > 1 month and do not require systemic glucocorticoid administration are allowed

• Major surgery within 4 weeks of ARGX-110 first dose administration

• Unresolved grade 3 or 4 toxicity from prior therapy (except mucositis from local radiation therapy).

• Active, untreated viral, bacterial, or systemic fungal infection

• Childbearing potential unless using an adequate measure of contraception

• Pregnancy or lactation. History of hypersensitivity to recombinant proteins

• Any clinical finding, including psychiatric and behavioural problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study

Related Conditions & MeSH terms

• Cancer
• Nasopharyngeal Neoplasms

Intervention

Drug:
• ARGX-110

Locations

Country	Name	City	State
Belgium	UZG - Universitair Ziekenhuis Gent	Gent

Sponsors (1)

Lead Sponsor	Collaborator
argenx BVBA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and grading of AEs	Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03	measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378
Secondary	Pharmacokinetic profile of ARGX110 by Cmax	Change from baseline in Measurement of drug concentration in the blood	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
Secondary	Pharmacokinetic profile of ARGX110 by AUC	Change in Measurement of drug concentration in the blood	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
Secondary	Biomarkers CD70 immunohistochemistry (IHC)	Change in Measurement of concentration in tumor tissue	measured at Screening, Day 42, and thereafter every 42 days until day Day 378