NL-OMON27131
Suspended
Not Applicable
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.
VU University Medical Center0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 18-year old patients with systemic sclerosis-associated pulmonary arterial hypertension (SScPAH)
- Sponsor
- VU University Medical Center
- Enrollment
- 20
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
Similar Trials
Withdrawn
Phase 2
The Effects of Epidermal Growth Factor Receptor (EGFR) Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis A phase II controlled open-label safety and efficacy study.high pulmonary vascular pressure associated with scleroderma100192801001076110037454NL-OMON30491Vrije Universiteit Medisch Centrum20
Unknown
Phase 2
The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without ErlotinibMetastatic Pancreatic CancerNCT01608841Taipei Veterans General Hospital, Taiwan88
Suspended
Phase 2
Panitumumab as second line therapy for advanced pancreatic ductal adenocarcinoma with wild-type KRAS geneKRAS wild-type unresectable or metastatic pancreatic ductal adenocarcinomaCancer - PancreaticACTRN12617000540314Dr Daniel Croagh24
Completed
Not Applicable
The effects of epidermal growth factor receptor inhibition on pulmonary arterial hypertension associated with systemic sclerosisSclerosis-associated Pulmonary Arterial Hypertension (SScPAH)Circulatory SystemPulmonary Arterial HypertensionISRCTN75611179VU University Medical Centre (The Netherlands)20
Completed
Not Applicable
Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung CancerNon-Small-Cell Lung CarcinomaNCT01255150National Cancer Institute (NCI)15