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

Sponsor
argenx (Industry)
Overall Status
Completed
CT.gov ID
NCT02759250
Collaborator
(none)
11
Enrollment
1
Location
3
Arms
40
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Apr 25, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: adjuvant monotherapy

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

Drug: ARGX-110
Experimental: metastatic/recurrent monotherapy

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

Drug: ARGX-110
Experimental: 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.

Drug: ARGX-110

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZG - Universitair Ziekenhuis Gent Gent Belgium

Sponsors and Collaborators

  • argenx

Investigators

  • Principal Investigator: Sylvie Rottey, MD, UZG - Universitair Ziekenhuis Gent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
argenx
ClinicalTrials.gov Identifier:
NCT02759250
Other Study ID Numbers:
  • ARGX-110-1401
First Posted:
May 3, 2016
Last Update Posted:
Aug 8, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Nasopharyngeal Carcinoma

Study Results

No Results Posted as of Aug 8, 2018