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

NCT02759250 | Completed Phase 1

• 1 other identifier: ARGX-110-1401
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• Biomarkers CD70 immunohistochemistry (IHC)

  measured at Screening, Day 42, and thereafter every 42 days until day Day 378

Study Arms (3)

adjuvant monotherapy

EXPERIMENTAL

ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles

Drug: ARGX-110

metastatic/recurrent monotherapy

EXPERIMENTAL

ARGX-110 5mg/kg once every three weeks until disease progression

Drug: ARGX-110

metastatic/recurrent combination therapy

EXPERIMENTAL

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.

Drug: ARGX-110

Interventions

ARGX-110 DRUG

adjuvant monotherapy; metastatic/recurrent combination therapy; metastatic/recurrent monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (1)

UZG - Universitair Ziekenhuis Gent

Ghent, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sylvie Rottey, MD

  UZG - Universitair Ziekenhuis Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 3, 2016
• Study Start: February 1, 2015
• Primary Completion: April 25, 2018
• Study Completion: June 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

BE (1)