CancerPhase 1NCT02759250
A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
A Phase 1 study testing ARGX-110 in people with Cancer, run by argenx at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ARGX-110
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Cancer
- Being tested
- ARGX-110
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-110Drug
| Study group | Role | What they receive |
|---|---|---|
| adjuvant monotherapy | Experimental | ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles Receives: Drug: ARGX-110 |
| metastatic/recurrent monotherapy | Experimental | ARGX-110 5mg/kg once every three weeks until disease progression Receives: Drug: ARGX-110 |
| metastatic/recurrent combination therapy | Experimental | 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. Receives: Drug: ARGX-110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378
Secondary outcomes (3)
Pharmacokinetic profile of ARGX110 by Cmax
Change from baseline in Measurement of drug concentration in the blood
Measured: 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
Change in Measurement of drug concentration in the blood
Measured: 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)
Change in Measurement of concentration in tumor tissue
Measured: measured at Screening, Day 42, and thereafter every 42 days until day Day 378
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startFeb 2015
- Primary completion25 Apr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sylvie Rottey, MD, Principal investigator, UZG - Universitair Ziekenhuis Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759250
- Sponsor's protocol ID
- ARGX-110-1401
- Status last verified
- Aug 2018
- First submitted
- 22 Apr 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT02759250
- Acronym / sponsor ID
- ARGX-110-1401
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adjuvant monotherapy | Experimental | Drug: ARGX-110ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles |
| metastatic/recurrent monotherapy | Experimental | Drug: ARGX-110ARGX-110 5mg/kg once every three weeks until disease progression |
| metastatic/recurrent combination therapy | Experimental | Drug: ARGX-110ARGX-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGX-110 | Drug | adjuvant monotherapy, metastatic/recurrent combination therapy, metastatic/recurrent monotherapy |
Primary outcome
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
3 secondary outcomes
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
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
Biomarkers CD70 immunohistochemistry (IHC)
Time frame: measured at Screening, Day 42, and thereafter every 42 days until day Day 378
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Rottey, MD principal investigator
UZG - Universitair Ziekenhuis Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARGX-110 in people with Cancer, run by argenx at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.