Phase 2
Completed N=30
Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Source: ClinicalTrials.gov NCT01054625 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Jan 2014
Primary outcomePrimary: Maximum Plasma Concentration of Zalutumumab After Fourth Infusion — 104.3; 258.1; 494.3 mg/L
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration of Zalutumumab After Fourth Infusion |
104.3; 258.1; 494.3 | — |
| PRIMARY Area Under the Curve 0-7 Days |
9308; 25091; 52158 | — |
| SECONDARY Area Under the Curve 0-21 Days |
12728; 44275; 105960 | — |
| SECONDARY Elimination Half-life |
63; 193; 283 | — |
| SECONDARY Clearance |
0.025; 0.018; 0.019 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Phase |
2.28; 4.99; 7.83 | — |
| SECONDARY Apparent Volume of Distribution at Steady State |
3.23; 4.86; 7.72 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01054625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.