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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
argenx

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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