Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NCT01054625 | Completed Phase 1 Results

• 1 other identifier: GEN211
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Neoplasms; anti-EGFr monoclonal antibody; Zalutumumab

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• 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)

• Elimination Half-life

  Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)

• Clearance

  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

  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

  Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)

Study Arms (3)

zalutumumab 4 mg/kg

EXPERIMENTAL

zalutumumab 4 mg/kg iv single infusion week 1,3, 4 and 5

Biological: zalutumumab

zalutumumab 8 mg/kg

EXPERIMENTAL

zalutumumab 8 mg/kg iv single infusion week 1, 3, 4 and 5

Biological: zalutumumab

zalutumumab 16 mg/kg

EXPERIMENTAL

zalutumumab 16 mg/kg iv single infusion week 1, 3, 4 and 5

Biological: zalutumumab

Interventions

zalutumumab BIOLOGICAL

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.

zalutumumab 16 mg/kg; zalutumumab 4 mg/kg; zalutumumab 8 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Genmab: lead

Study Sites (7)

Cliniques Universitaires SaintLuc

Brussels, 1200, Belgium

Location

Uz Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Uzsoki Hospital

Budapest, H-1145, Hungary

Location

Vas Megye es Szombathely

Szombathely, 9700, Hungary

Location

Narodny onkologicky ustav

Bratislava, 833 10, Slovakia

Location

FN Tnava

Trnava, 917 75, Slovakia

Location

St James's Institute of Oncology

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

zalutumumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Eva Järlid Westerberg, VP Clinical Operations
• Organization: Genmab A/S

E.Westerberg@genmab.com

+45 7020 2728

Study Officials

• Jean-Pascal Machiels, MD, PhD

  Cliniques Universitaires SaintLuc, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 22, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 3, 2023
• Results First Posted: January 3, 2014

Record last verified: 2023-08

Locations

GB (1); BE (2); HU (2); SL (2)