Zalutumumab in Head and Neck Cancer
Sponsor
Genmab (Industry)
Overall Status
Completed
CT.gov ID
NCT00093041
Collaborator
(none)
28
5
6
13
5.6
0.4
Study Details
Study Description
Brief Summary
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
28 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Start Date
:
Dec 1, 2003
Actual Primary Completion Date
:
Jan 1, 2005
Actual Study Completion Date
:
Jan 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Zalutumumab 0.15 mg/kg
|
Drug: Zalutumumab
Weekly infusion
|
| Experimental: Zalutumumab 0.5 mg/kg
|
Drug: Zalutumumab
Weekly infusion
|
| Experimental: Zalutumumab 1 mg/kg
|
Drug: Zalutumumab
Weekly infusion
|
| Experimental: Zalutumumab 2 mg/kg
|
Drug: Zalutumumab
Weekly infusion
|
| Experimental: Zalutumumab 4 mg/kg
|
Drug: Zalutumumab
Weekly infusion
|
| Experimental: Zalutumumab 8 mg/kg
|
Drug: Zalutumumab
Weekly infusion
|
Outcome Measures
Primary Outcome Measures
- Adverse Events [Overall Study]
Number of participants reporting at least one adverse event
Secondary Outcome Measures
- Overall Response, Classification [8 weeks]
Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
The study population eligible for this study is adult male or female patients of good performance status having a histologically confirmed recurrent or metastatic SCCHN, not amenable to standard curative or palliative therapies.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet | Copenhagen Ø | Denmark | 2100 | |
| 2 | Odense Universitetshospital | Odense | Denmark | 5000 | |
| 3 | Århus Kommunehospital | Århus C | Denmark | 8000 | |
| 4 | Universitets Sjukhuset i Lund | Lund | Sweden | 221 85 | |
| 5 | Uppsala Akademiska Sjukhus | Uppsala | Sweden | 751 85 |
Sponsors and Collaborators
- Genmab
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Genmab
ClinicalTrials.gov Identifier:
NCT00093041
Other Study ID Numbers:
- Zalutumumab
First Posted:
Oct 1, 2004
Last Update Posted:
Dec 22, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Genmab
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | ||||||
| Period Title: Overall Study | ||||||
| STARTED | 4 | 4 | 5 | 4 | 4 | 7 |
| COMPLETED | 2 | 1 | 3 | 3 | 3 | 4 |
| NOT COMPLETED | 2 | 3 | 2 | 1 | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||||||
| Overall Participants | 4 | 4 | 5 | 4 | 4 | 7 | 28 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
4
100%
|
4
100%
|
4
80%
|
3
75%
|
4
100%
|
6
85.7%
|
25
89.3%
|
| >=65 years |
0
0%
|
0
0%
|
1
20%
|
1
25%
|
0
0%
|
1
14.3%
|
3
10.7%
|
| Age (years) [Median (Full Range) ] | |||||||
| Median (Full Range) [years] |
54
|
59
|
57
|
55
|
53
|
58
|
57
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
2
50%
|
1
25%
|
1
20%
|
1
25%
|
0
0%
|
1
14.3%
|
6
21.4%
|
| Male |
2
50%
|
3
75%
|
4
80%
|
3
75%
|
4
100%
|
6
85.7%
|
22
78.6%
|
| Region of Enrollment (participants) [Number] | |||||||
| Denmark |
4
100%
|
3
75%
|
3
60%
|
3
75%
|
4
100%
|
6
85.7%
|
23
82.1%
|
| Sweden |
0
0%
|
1
25%
|
2
40%
|
1
25%
|
0
0%
|
1
14.3%
|
5
17.9%
|
Outcome Measures
| Title | Adverse Events |
|---|---|
| Description | Number of participants reporting at least one adverse event |
| Time Frame | Overall Study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants reporting at least one adverse event |
| Arm/Group Title | Zalatumumab 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | ||||||
| Measure Participants | 4 | 4 | 5 | 4 | 4 | 7 |
| Number [participants] |
4
100%
|
4
100%
|
5
100%
|
4
100%
|
4
100%
|
7
100%
|
| Title | Overall Response, Classification |
|---|---|
| Description | Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Zalatumumab 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 |
|---|---|---|---|---|---|---|
| Arm/Group Description | ||||||
| Measure Participants | 4 | 4 | 5 | 4 | 4 | 7 |
| Complete Response |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Partial Response |
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
1
14.3%
|
| Stable Disease |
0
0%
|
0
0%
|
1
20%
|
2
50%
|
3
75%
|
3
42.9%
|
| Progression |
2
50%
|
1
25%
|
2
40%
|
0
0%
|
1
25%
|
2
28.6%
|
| Missing |
2
50%
|
3
75%
|
2
40%
|
1
25%
|
0
0%
|
1
14.3%
|
Adverse Events
| Time Frame | 8 weeks | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | 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 | ||||||
| Arm/Group Description | ||||||||||||
All Cause Mortality |
||||||||||||
| 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 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| 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 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 3/4 (75%) | 5/5 (100%) | 1/4 (25%) | 0/4 (0%) | 6/7 (85.7%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Duodenal ulcer | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Constipation | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Dysphagia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| Gastric ulcer | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| General disorders | ||||||||||||
| Bleeding from tumour | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Administration site condition | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Pyrexia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| Infections and infestations | ||||||||||||
| Sepsis | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| Streptococcal infection | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| Syncope vasovagal | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Dehydration | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Back pain | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| Nervous system disorders | ||||||||||||
| Syncope | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Pneumonia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Dyspnoea | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 2/5 (40%) | 3 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| 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 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 4/4 (100%) | 5/5 (100%) | 4/4 (100%) | 4/4 (100%) | 7/7 (100%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anemia | 1/4 (25%) | 1 | 2/4 (50%) | 2 | 2/5 (40%) | 3 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/7 (28.6%) | 3 |
| Gastrointestinal disorders | ||||||||||||
| Nausea | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/4 (25%) | 1 | 2/4 (50%) | 4 | 2/7 (28.6%) | 2 |
| Constipation | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 2/5 (40%) | 2 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Vomiting | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 2/5 (40%) | 4 | 0/4 (0%) | 0 | 1/4 (25%) | 2 | 0/7 (0%) | 0 |
| Diarrhoea | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| General disorders | ||||||||||||
| Pyrexia | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 3/5 (60%) | 3 | 1/4 (25%) | 2 | 1/4 (25%) | 1 | 5/7 (71.4%) | 6 |
| Fatigue | 2/4 (50%) | 2 | 0/4 (0%) | 0 | 1/5 (20%) | 2 | 2/4 (50%) | 3 | 0/4 (0%) | 0 | 4/7 (57.1%) | 6 |
| Headache | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 3/4 (75%) | 3 | 2/7 (28.6%) | 3 |
| Rigors | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 3 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 4/7 (57.1%) | 5 |
| Sweating increased | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 1/4 (25%) | 2 | 1/4 (25%) | 1 | 1/7 (14.3%) | 1 |
| Flushing | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 2 | 1/4 (25%) | 2 | 1/7 (14.3%) | 3 |
| Influenza like | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/7 (0%) | 0 |
| Oedema | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/7 (14.3%) | 1 |
| Asthenia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Dyspnoea | 0/4 (0%) | 0 | 1/4 (25%) | 2 | 3/5 (60%) | 4 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 2/7 (28.6%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Rash | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/5 (40%) | 2 | 3/4 (75%) | 3 | 4/4 (100%) | 5 | 5/7 (71.4%) | 6 |
Limitations/Caveats
The study comprised a single-dose escalation part for assessment of safety and a repeat dose extension including 4 weekly infusions. Please see the referred publication by Bastholt at al 2007 for detailed results.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | VP Clinical Operations Eva Järlid Westerberg |
|---|---|
| Organization | Genmab A/S |
| Phone | +45 7020 2728 |
| E.Westerberg@genmab.com |
Responsible Party:
Genmab
ClinicalTrials.gov Identifier:
NCT00093041
Other Study ID Numbers:
- Zalutumumab
First Posted:
Oct 1, 2004
Last Update Posted:
Dec 22, 2011
Last Verified:
Nov 1, 2011