Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01598038
• Other study ID #: PEVERENAL
• Status: Terminated
• Phase: N/A
• First received: May 10, 2012
• Last updated: July 27, 2017
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2017
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged = 18 year-old.

2. Histologically documented renal cell carcinoma whatever the type.

3. One or two prior therapy with cytokines and/or VEFG-ligand inhibitors are permitted.

4. Patients with an indication to receive everolimus treatment

5. Patients able and willing to give written informed consent, before the first screening procedure.

Exclusion Criteria:

1. Patients currently receiving chemotherapy or immunotherapy

2. Prior treatment with temsirolimus

3. Contraindication in everolimus :

• Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.

• Patients with severe hepatic impairment (Child-Pugh class C)

• Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4. Pregnant or breastfeeding women

5. Patients unwilling to or unable to comply with the protocol.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Blood sample
Everolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Find a relationship between everolimus through blood level and treatment safety.	We hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalised dosage treatment and permit a better tolerance without altering efficacy.	2 years