Head and Neck Neoplasms
Conditions
Keywords
Head and neck cancer, squamous cell carcinoma of the head and neck
Brief summary
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Interventions
DRUGZalutumumab
Weekly infusion
Sponsors
Genmab
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx. * Primary or recurrent disease for which no curative or established palliative treatments are amenable * WHO performance status of 1 or 2.
Exclusion criteria
* Received certain other treatments within 4 weeks prior to administration of study drug * Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis). * Skin disease requiring systemic or local corticosteroid therapy. * Known brain metastasis or leptomeningeal disease. * Signs or symptoms of acute illness. * Bacterial, fungal or viral infection. * Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases. * Pregnant or breast-feeding women. * Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial. * Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From study start (Day 0) until follow-up period (up to Day 77) | Number of participants reporting at least one adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response (OR), Classification | 8 weeks | Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions. |
Countries
Denmark, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zalutumumab 0.15 mg/kg | 4 |
| Zalutumumab 0.5 mg/kg | 4 |
| Zalutumumab 1 mg/kg | 5 |
| Zalutumumab 2 mg/kg | 4 |
| Zalutumumab 4 mg/kg | 4 |
| Zalutumumab 8 mg/kg | 7 |
| Total | 28 |
Baseline characteristics
| Characteristic | Zalutumumab 0.15 mg/kg | Zalutumumab 0.5 mg/kg | Zalutumumab 1 mg/kg | Zalutumumab 2 mg/kg | Zalutumumab 4 mg/kg | Zalutumumab 8 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 6 Participants | 25 Participants |
| Age, Continuous | 54 years | 59 years | 57 years | 55 years | 53 years | 58 years | 57 years |
| Region of Enrollment Denmark | 4 participants | 3 participants | 3 participants | 3 participants | 4 participants | 6 participants | 23 participants |
| Region of Enrollment Sweden | 0 participants | 1 participants | 2 participants | 1 participants | 0 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 6 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 5 / 5 | 4 / 4 | 4 / 4 | 7 / 7 |
| serious Total, serious adverse events | 0 / 4 | 3 / 4 | 5 / 5 | 1 / 4 | 0 / 4 | 6 / 7 |
Outcome results
Primary
Adverse Events
Number of participants reporting at least one adverse event.
Time frame: From study start (Day 0) until follow-up period (up to Day 77)
Population: Number of participants reporting at least one adverse event
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zalatumumab 0.15 mg/kg | Adverse Events | 4 participants |
| Zalutumumab 0.5 mg/kg | Adverse Events | 4 participants |
| Zalutumumab 1 mg/kg | Adverse Events | 5 participants |
| Zalutumumab 2 mg/kg | Adverse Events | 4 participants |
| Zalutumumab 4 mg/kg | Adverse Events | 4 participants |
| Zalutumumab 8 mg/kg | Adverse Events | 7 participants |
Secondary
Overall Response (OR), Classification
Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zalatumumab 0.15 mg/kg | Overall Response (OR), Classification | Progression | 2 participants |
| Zalatumumab 0.15 mg/kg | Overall Response (OR), Classification | Partial Response | 0 participants |
| Zalatumumab 0.15 mg/kg | Overall Response (OR), Classification | Complete Response | 0 participants |
| Zalatumumab 0.15 mg/kg | Overall Response (OR), Classification | Missing | 2 participants |
| Zalatumumab 0.15 mg/kg | Overall Response (OR), Classification | Stable Disease | 0 participants |
| Zalutumumab 0.5 mg/kg | Overall Response (OR), Classification | Partial Response | 0 participants |
| Zalutumumab 0.5 mg/kg | Overall Response (OR), Classification | Progression | 1 participants |
| Zalutumumab 0.5 mg/kg | Overall Response (OR), Classification | Complete Response | 0 participants |
| Zalutumumab 0.5 mg/kg | Overall Response (OR), Classification | Missing | 3 participants |
| Zalutumumab 0.5 mg/kg | Overall Response (OR), Classification | Stable Disease | 0 participants |
| Zalutumumab 1 mg/kg | Overall Response (OR), Classification | Partial Response | 0 participants |
| Zalutumumab 1 mg/kg | Overall Response (OR), Classification | Progression | 2 participants |
| Zalutumumab 1 mg/kg | Overall Response (OR), Classification | Missing | 2 participants |
| Zalutumumab 1 mg/kg | Overall Response (OR), Classification | Stable Disease | 1 participants |
| Zalutumumab 1 mg/kg | Overall Response (OR), Classification | Complete Response | 0 participants |
| Zalutumumab 2 mg/kg | Overall Response (OR), Classification | Stable Disease | 2 participants |
| Zalutumumab 2 mg/kg | Overall Response (OR), Classification | Complete Response | 0 participants |
| Zalutumumab 2 mg/kg | Overall Response (OR), Classification | Partial Response | 1 participants |
| Zalutumumab 2 mg/kg | Overall Response (OR), Classification | Progression | 0 participants |
| Zalutumumab 2 mg/kg | Overall Response (OR), Classification | Missing | 1 participants |
| Zalutumumab 4 mg/kg | Overall Response (OR), Classification | Progression | 1 participants |
| Zalutumumab 4 mg/kg | Overall Response (OR), Classification | Complete Response | 0 participants |
| Zalutumumab 4 mg/kg | Overall Response (OR), Classification | Missing | 0 participants |
| Zalutumumab 4 mg/kg | Overall Response (OR), Classification | Partial Response | 0 participants |
| Zalutumumab 4 mg/kg | Overall Response (OR), Classification | Stable Disease | 3 participants |
| Zalutumumab 8 mg/kg | Overall Response (OR), Classification | Complete Response | 0 participants |
| Zalutumumab 8 mg/kg | Overall Response (OR), Classification | Progression | 2 participants |
| Zalutumumab 8 mg/kg | Overall Response (OR), Classification | Partial Response | 1 participants |
| Zalutumumab 8 mg/kg | Overall Response (OR), Classification | Missing | 1 participants |
| Zalutumumab 8 mg/kg | Overall Response (OR), Classification | Stable Disease | 3 participants |