Condition category
Circulatory System
Date applied
01/02/2007
Date assigned
01/02/2007
Last edited
06/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Other

Trial 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

Phase

Phase II

Drug names

Cetuximab

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

01/01/2010

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

Trial 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/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes