Contact information
Type
Scientific
Contact name
Dr A Boonstra
ORCID ID
Contact details
VU University Medical Center
Department of Pulmonary Diseases
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 4782
a.boonstra@vumc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
155/2006
Study information
Scientific title
Acronym
Study hypothesis
As Epidermal Growth Factor Receptor (EGFR) plays a role in pathogenesis of both pulmonary arterial hypertension and systemic sclerosis, EGFR inhibition will lead to beneficial effects in disease course.
Ethics approval(s)
Approval received from the Medical Ethics Review Committee of VU University Medical Centre.
Study design
Phase II study, open-labelled trial
Primary study design
Interventional
Secondary study design
Single-centre
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
Sclerosis-associated Pulmonary Arterial Hypertension (SScPAH)
Intervention
All participants will receive cetuximab at a loading dose of 400 mg/m^2 in week one, followed by a weekly dose of 250 mg/m^2 starting from week two, up to a total of 12 weeks.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Cetuximab
Primary outcome measure
Safety: recorded by assessment and documentation in the Case Report Form (CRF) file of adverse events and toxicity (physical examination [with special attention to skin toxicity], laboratory data) at pre-treatment, treatment visits (week one to 12), and follow-up (six months, 12 months).
Secondary outcome measures
Efficacy: measured by effects on six minute walk test, stroke volume, changes in High Resolution Computed Tomography (HRCT), N-Terminal B-type Natriuretic Peptide (NT-pro-BNP).
Overall study start date
01/01/2007
Overall study end date
01/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
A subject is eligible for inclusion in this study only if all of the following criteria apply:
1. Written informed consent
2. Systemic sclerosis
3. Pulmonary Arterial Hypertension (PAH) with a mean Pulmonary Arterial Pressure (PAP) of above 25 mmHg measured during rest
4. Pulmonary Vascular Resistance (PVR) above 300 dynes
5. Total Lung Capacity (TLC) more than 70%
6. New York Heart Association (NYHA) class III and/or six-Minute Walk Test (6-MWT) less than 80% predicted
7.Conventional PAH treatment and/or bosentan and/or sildenafil treatment
8. Stability on medication during the previous three months (defined as stable or decrease of 6-MWT after three months of treatment)
Participant type(s)
Patient
Age group
Not Specified
Sex
Both
Target number of participants
20
Participant exclusion criteria
A subject will be excluded from this study in case of the following criteria:
1. Left ventricular dysfunction
2. Valvular heart disease
3. Pericardial constriction
4. Wedge pressure more than or equal to 15 mmHg
5. Chronic thromboembolic pulmonary hypertension
6. Uncontrolled sleep apnea
7. History of malignancies
8. Overt right heart failure
9. History or presence of skin ulcerations
10. Women Of Child-Bearing potential (WOCB) who are unwilling or unable to use contraceptives
11. Sexually active fertile man not using effective birth control if their partners are WOCB
12. Severe abnormality of the cornea
13. Inadequate haematologic function defined by an absolute neutrophil count less than 1,500/mm^3, platelet count less than 80,000/mm^3 and haemoblobin level of less than 9 g/dL
14. Inadequate hepatic function defined by a total bilirubin level 1.5 times the Upper Limit of Normal (ULN) and ASpartate AminoTransferase (ASAT) levels 2.5 times ULN
15. Inadequate renal function defined by a serum creatinine level more than 1.5 times ULN (alternative: Cockroft less than 50 ml/min)
16. Substances that inhibit CYP3A4 activity, such as rifampicin, phenytoin, ketoconazole, itraconazole
Recruitment start date
01/01/2007
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Centre (The Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.vumc.nl/english/#http://www.vumc.nl/english/
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
VU University Medical Center (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|