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

NCT ID: NCT02759250

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

adjuvant monotherapy

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

Group Type: EXPERIMENTAL

ARGX-110

Intervention Type: DRUG

metastatic/recurrent monotherapy

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

Group Type: EXPERIMENTAL

ARGX-110

Intervention Type: DRUG

metastatic/recurrent combination therapy

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.

Group Type: EXPERIMENTAL

ARGX-110

Intervention Type: DRUG

Interventions

ARGX-110

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

argenx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Rottey, MD

Role: PRINCIPAL_INVESTIGATOR

UZG - Universitair Ziekenhuis Gent

Locations

UZG - Universitair Ziekenhuis Gent

Ghent, , Belgium

Countries

Belgium

Other Identifiers

ARGX-110-1401

Identifier Type: -

Identifier Source: org_study_id