Head and Neck CancerPhase 1/2NCT01054625
Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
A Phase 1/2 study testing zalutumumab in people with Head and Neck Cancer, run by Genmab at 7 sites in 4 countries.
Trial summary
This study is to support current and future Zalutumumab studies by increasing the Pharmacokinetic (PK) knowledge of the drug. PK is the study of how a drug is absorbed (taken up), distributed (moved around), metabolised (broken down) and excreted (removed) by the body, in relation to time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- zalutumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Mar 2010to Oct 2011
- Phase
- Phase 1/2
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
- Males and females ≥ 18 years.
- Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy. Diagnosis will have been confirmed using a biopsy of the tumour.
- Patients having, based on the investigators judgment, had disease progression and for whom curative therapy is not possible.
- Patients with a WHO performance status ≤ 2 and a life expectancy of greater than 3 months.
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
Who cannot join
- Patients previously treated with any Epidermal Growth Factor Receptor (EGFR) targeted therapy such as anti-EGFR monoclonal antibodies or small molecule inhibitors within 6 months prior to visit 2 (first treatment).
- Received the following treatments within 4 weeks prior to Visit 2 (first treatment):
- Cytotoxic or cytostatic anticancer chemotherapy
- Total tumor resection
- Radiotherapy of > 50 Gy to gross tumor volume
- Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis
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- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1 (screening), congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
- History of significant cerebrovascular disease
- Known HIV infection
- Known hepatitis B and/or hepatitis C
- Screening laboratory values:
- Neutrophils < 1.5 x109/l
- Platelets < 75 x109/l
- ALAT > 2.5 times the upper limit of normal (unless known liver metastases exceptions will be dealt with on a case by case basis)
- ALP > 2.5 times the upper limit of normal (unless known liver metastases exceptions will be dealt with on a case by case basis)
- Bilirubin > 1.5 times the upper limit of normal
- Creatinine clearance < 50 ml/min (measured or calculated by the CockgroftGault method)
- Patients who have received treatment with any non-marketed drug substance within 4 weeks before Visit 1(screening)
- Current participation in any other interventional clinical study
- Patients with a BMI ≥ 30 kg/m2
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Breast feeding women or women with a positive pregnancy test at Visit 1 (screening)
- Women of childbearing potential not willing to use adequate contraception such as hormonal birth control or intrauterine device during study.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Belgium2 sites
Cliniques Universitaires SaintLuc
Brussels, 1200
Uz Leuven - Campus Gasthuisberg
Leuven, 3000
Hungary2 sites
Uzsoki Hospital
Budapest, H-1145
Vas Megye es Szombathely
Szombathely, 9700
Slovakia2 sites
Narodny onkologicky ustav
Bratislava, 833 10
FN Tnava
Trnava, 917 75
About this study
Official title: An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic Profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Non-curable Patients With SCCHN
This study is to support current and future Zalutumumab studies by increasing the Pharmacokinetic (PK) knowledge of the drug. PK is the study of how a drug is absorbed (taken up), distributed (moved around), metabolised (broken down) and excreted (removed) by the body, in relation to time. The first PK trial only went up to 8 mg/kg, and, as there has been some indication that the PK profile for the higher and lower doses is different, this needs to be further evaluated. Furthermore, there is a need for more PK data on dosing with 16mg/kg.
The aim with this study is therefore to evaluate the PK profiles at different doses of Zalutumumab and the amount of drug in the blood at different time points after single and multiple doses. The results of this study, combined with data from completed and ongoing Zalutumumab studies, will enable us to provide patients with an effective treatment option which may significantly prolong their survival and/or improve their quality of life.
Read the detailed description
This study is to look at the Pharmacokinetics (PK) of Zalutumumab in patients with Head and Neck Cancer. 26 participants will be treated with the study drug Zalutumumab at 4 different doses. Zalutumumab will be given at day 0, day 14, day 21 and day 28. Blood samples (for PK and to check the participant's safety) will be taken before drug is given. Blood samples for PK only will be taken directly after drug is given at all treatment visits and also at +3hr and +12hrs on day 0 and day 28 which may require an overnight stay.
Blood samples for PK only are also taken on days between treatments. After treatment on day 28, eight more blood samples will be taken over 3 weeks. On day 49 participants may enter an optional extended treatment period receiving the drug weekly until it is no longer appropriate for the participant (doctor/participant decision or cancer has advanced).
Dosing in the extended treatment period will start at 16mg/kg. The correct dose for the participant will be checked at each visit by looking for the presence and severity of skin rash. This is a common side effect of medicines like Zalutumumab which block the Epidermal Growth Factor Receptor. The severity of the skin rash is used as a guide for dosing. A mild rash could mean more medication is needed, a severe rash will mean the participant needs a break from the medication. End of study is 8 weeks after the last dose of Zalutumumab and blood samples will be taken +4weeks and +8weeks after the last dose of drug.
- Conditions
- Head and Neck Cancer
- Being tested
- zalutumumab
- Keywords
- Squamous Cell Carcinoma of the Head and Neck, Head and Neck Cancer, Head and Neck Neoplasms, anti-EGFr monoclonal antibody, Zalutumumab
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zalutumumabBiological
Zalutumumab is a clear to opalescent liquid. It is intended for intravenous infusion following dilution in sterile, pyrogen free, 0.9% NaCl. Patients will be treated at a specified dose of Zalutumumab over a period of 7 weeks. The dose will be 4mg/kg, 8mg/kg or 16mg/kg depending on when they enter the study. The study will begin with 6 patients on 4mg/kg, then 10 patients on 8mg/kg and lastly 10 patients on 16mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| zalutumumab 4 mg/kg | Experimental | zalutumumab 4 mg/kg iv single infusion week 1,3, 4 and 5 Receives: Biological: zalutumumab |
| zalutumumab 8 mg/kg | Experimental | zalutumumab 8 mg/kg iv single infusion week 1, 3, 4 and 5 Receives: Biological: zalutumumab |
| zalutumumab 16 mg/kg | Experimental | zalutumumab 16 mg/kg iv single infusion week 1, 3, 4 and 5 Receives: Biological: zalutumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration of Zalutumumab After Fourth Infusion
Measured: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)
Area Under the Curve 0-7 Days
Measured: Pre-dose and post dose at multiple timepoints from start of first infusion up to end of last infusion (Day 0 to 7)
Secondary outcomes (5)
Area Under the Curve 0-21 Days
Measured: Pre-dose and post dose at multiple timepoints from start of fourth infusion up to end of last infusion (Day 0 to 21)
Elimination Half-life
Measured: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)
Clearance
Measured: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)
Apparent Volume of Distribution During the Terminal Phase
Measured: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)
Apparent Volume of Distribution at Steady State
Measured: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by GenmabThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal Machiels, MD, PhD, Principal investigator, Cliniques Universitaires SaintLuc, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054625
- Sponsor's protocol ID
- GEN211
- Status last verified
- Aug 2023
- First submitted
- 15 Jan 2010
- Last updated
- 3 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No