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

August 7, 2018 updated by: argenx

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium
        • UZG - Universitair Ziekenhuis Gent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and grading of AEs
Time Frame: 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
measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic profile of ARGX110 by Cmax
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: measured at Screening, Day 42, and thereafter every 42 days until day Day 378
Change in Measurement of concentration in tumor tissue
measured at Screening, Day 42, and thereafter every 42 days until day Day 378

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 25, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-110-1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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