- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01227213
The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life.
Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.
Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow.
Study design: Single-centre non randomized observational study Study population: 30 Patients (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Nijmegen, Nederland, 6500HB
- Radboud University Nijmegen Medical Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Subject is able and willing to sign the Informed Consent Form
- Age 18 years or older
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- mRCC patients in which the treatment of choice is sunitinib
Exclusion Criteria:
- Use of corticosteroids
- Any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
- Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
- Patients being treated with oral anticoagulants if to be included in group A.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Endothelial function
Tidsramme: 2 weeks
|
Group A: Vasomotor response to intra-arterially administered doses of acetylcholine and nitroprusside before and after start sunitinib |
2 weeks
|
|
Insulin sensitivity
Tidsramme: 2 weeks
|
Group B: Insulin sensitivity measured by hyperinsulinemic euglycemic clamp before and after start sunitinib |
2 weeks
|
|
GFR and renal perfusion flow
Tidsramme: 2 weeks
|
Group C: GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib |
2 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Vekt
Tidsramme: 3 måneder
|
3 måneder
|
|
Blodtrykk
Tidsramme: 3 måneder
|
3 måneder
|
|
Laboratory evaluations
Tidsramme: 12 weeks
|
12 weeks
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Thijs AM, van Herpen CM, Verweij V, Pertijs J, van den Broek PH, van der Graaf WT, Rongen GA. Impaired endothelium-dependent vasodilation does not initiate the development of sunitinib-associated hypertension. J Hypertens. 2015 Oct;33(10):2075-82. doi: 10.1097/HJH.0000000000000662. Erratum In: J Hypertens. 2016 Jan;34(1):163.
- Thijs AM, Tack CJ, van der Graaf WT, Rongen GA, van Herpen CM. The early effect of sunitinib on insulin clearance in patients with metastatic renal cell carcinoma. Br J Clin Pharmacol. 2016 Apr;81(4):768-72. doi: 10.1111/bcp.12797. Epub 2016 Jan 14.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Neoplasmer etter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Nyre-neoplasmer
- Hyperinsulinisme
- Karsinom, nyrecelle
- Karsinom
- Insulinresistens
Andre studie-ID-numre
- SUMAVA
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