The Effects of Epidermal Growth Factor (EGFR) Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis.

The Effects of Epidermal Growth Factor (EGFR) Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis. A phase II open-label safety and efficacy study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27131

Enrollment

Registered

2006-12-29

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

18-year old patients with systemic sclerosis-associated pulmonary arterial hypertension (SScPAH)

Interventions

All participants will receive cetuximab at a loading dose of 400 mg/m2 in week 1, followed by a weekly dose of 250 mg/m2 starting from week 2, up to a total of 12 weeks.

Eligibility

Inclusion criteria

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. PAH with a mean PAP of above 25 mmHg measured during rest; 4. PVR above 300 dynes; 5. TLC > 70 %; 6. NYHA class III and/or 6 Minute Walk Test < 80% predicted; 7.Conventional PAH treatment and/or bosentan and/or sildenafil treatment; 8. Stability on medication during the previous 3 months (defined as stable or decrease of 6 MWT after 3 months of treatment).

Exclusion criteria

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 >/= 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 hematologic function defined by an absolute neutrophil count 1,5 times ULN (alternative: Cockroft <50 ml/min); 16. Substances that inhibit CYP3A4 activity, such as rifampicin, phenytoin, ketoconazole, itraconazole (see section 6.4.5).

Design outcomes

Primary

Measure	Time frame
Safety.	—

Secondary

Measure	Time frame
Efficacy, measured by effects on six minute walk test, stroke volume, changes n HRCT, NT-pro-BNP.	—

Contacts

Public ContactA. Boonstra

VU University Medical Center, Department of Pulmonary Diseases, P.O. Box 7057

a.boonstra@vumc.nl+31 (0)20 4444782

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)