Head and Neck Cancer Clinical Trial
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
Verified date | August 2023 |
Source | Genmab |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | October 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires SaintLuc | Brussels | |
Belgium | Uz Leuven - Campus Gasthuisberg | Leuven | |
Hungary | Uzsoki Hospital | Budapest | |
Hungary | Vas Megye es Szombathely | Szombathely | |
Slovakia | Narodny onkologicky ustav | Bratislava | |
Slovakia | FN Tnava | Trnava | |
United Kingdom | St James's Institute of Oncology | Leeds |
Lead Sponsor | Collaborator |
---|---|
Genmab |
Belgium, Hungary, Slovakia, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Plasma Concentration of Zalutumumab After Fourth Infusion | Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days) | ||
Primary | Area Under the Curve 0-7 Days | Pre-dose and post dose at multiple timepoints from start of first infusion up to end of last infusion (Day 0 to 7) | ||
Secondary | Area Under the Curve 0-21 Days | Pre-dose and post dose at multiple timepoints from start of fourth infusion up to end of last infusion (Day 0 to 21) | ||
Secondary | Elimination Half-life | Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days) | ||
Secondary | Clearance | Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days) | ||
Secondary | Apparent Volume of Distribution During the Terminal Phase | Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days) | ||
Secondary | Apparent Volume of Distribution at Steady State | Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |