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

Primary Purpose

Cancer

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
ARGX-110
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZG - Universitair Ziekenhuis Gent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

adjuvant monotherapy

metastatic/recurrent monotherapy

metastatic/recurrent combination therapy

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetic profile of ARGX110 by Cmax
Change from baseline in Measurement of drug concentration in the blood
Pharmacokinetic profile of ARGX110 by AUC
Change in Measurement of drug concentration in the blood
Biomarkers CD70 immunohistochemistry (IHC)
Change in Measurement of concentration in tumor tissue

Full Information

First Posted
April 22, 2016
Last Updated
August 7, 2018
Sponsor
argenx
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1. Study Identification

Unique Protocol Identification Number
NCT02759250
Brief Title
A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
Official Title
A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 25, 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adjuvant monotherapy
Arm Type
Experimental
Arm Description
ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles
Arm Title
metastatic/recurrent monotherapy
Arm Type
Experimental
Arm Description
ARGX-110 5mg/kg once every three weeks until disease progression
Arm Title
metastatic/recurrent combination therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ARGX-110
Primary Outcome Measure Information:
Title
Incidence and grading of AEs
Description
Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03
Time Frame
measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile of ARGX110 by Cmax
Description
Change from baseline in Measurement of drug concentration in the blood
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
Title
Pharmacokinetic profile of ARGX110 by AUC
Description
Change in Measurement of drug concentration in the blood
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
Title
Biomarkers CD70 immunohistochemistry (IHC)
Description
Change in Measurement of concentration in tumor tissue
Time Frame
measured at Screening, Day 42, and thereafter every 42 days until day Day 378

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Rottey, MD
Organizational Affiliation
UZG - Universitair Ziekenhuis Gent
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZG - Universitair Ziekenhuis Gent
City
Gent
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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