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Trial record 16 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
arGEN-X BVBA
ClinicalTrials.gov Identifier:
NCT02759250
First received: April 22, 2016
Last updated: April 20, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Cancer
Drug: ARGX-110
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:


Further study details as provided by arGEN-X BVBA:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • 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


Estimated Enrollment: 15
Study Start Date: February 2015
Estimated Study Completion Date: July 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02759250

Locations
Belgium
UZG - Universitair Ziekenhuis Gent
Gent, Belgium
Sponsors and Collaborators
arGEN-X BVBA
Investigators
Principal Investigator: Sylvie Rottey, MD UZG - Universitair Ziekenhuis Gent
  More Information

Responsible Party: arGEN-X BVBA
ClinicalTrials.gov Identifier: NCT02759250     History of Changes
Other Study ID Numbers: ARGX-110-1401
Study First Received: April 22, 2016
Last Updated: April 20, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 27, 2017