Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer

Metastatic Kidney Cancer Clinical Trial

— BIOSUNTOX  

Official title:

Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03846128
• Other study ID #: 2017/181/HP
• Status: Not yet recruiting
• Start date: August 2019
• Est. completion date: May 2024

Study information

• Verified date: July 2019
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer.

Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient at least 18 years old

• Patient who read and understood the newsletter and signed the consent form

• Renal cell carcinoma histologically proven stage IV

• Metastatic stage proven on CT, synchronous or metachronous examination

• Patient operated on or not from the primary tumor

• Eligible for first-line systemic therapy with Sunitinib-targeted therapy for oncology urology

• Affiliation to a social security scheme

• Effective contraception (as defined by the WHO) for at least 3 months at the inclusion visit, during treatment and for 1 month after the end of the research (negative pregnancy test)

• Postmenopausal woman: confirmatory diagnosis (amenorrhea not clinically induced for more than 12 months at inclusion visit)

• General condition WHO 0 to 2

• Life expectancy estimated at more than 6 months at baseline

Exclusion Criteria:

• Non-metastatic disease

• Other cancer proven histologically, or in complete remission for less than 2 years

• Contraindication to SUTENT 50 mg hard capsules: Hypersensitivity to the active substance or to any of the excipients

• History of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer

• Pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception,

• Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship

• Patient currently involved in an interventional trial

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Metastatic Kidney Cancer

Intervention

Biological:
• blood sample
blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 1 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 2 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 3 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 4 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 5 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 6 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	At the end of Cycle 1 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	At the end of Cycle 2 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	At the end of Cycle 3 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	At the end of Cycle 4 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	At the end of Cycle 5 (each cycle is 28 days)
Primary	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	At the end of Cycle 6 (each cycle is 28 days)
Secondary	plasma desethyl-Sunitinib (DES) concentration	influence of plasma DES concentration on patients survival	Cycle1 Day14 (each cycle is 28 days)
Secondary	plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle1 Day14 (each cycle is 28 days)
Secondary	plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survivall	Cycle1 Day28 (each cycle is 28 days)
Secondary	plasma DES concentration	influence of plasma Sunitinib concentration on patients survival	Cycle1 Day28 (each cycle is 28 days)
Secondary	plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle2 Day28(each cycle is 28 days)
Secondary	plasma DES concentration	influence of plasma DES concentration on patients survival	Cycle2 Day28 (each cycle is 28 days)
Secondary	plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle3 Day28 (each cycle is 28 days)
Secondary	plasma DES concentration	Evaluate the influence of plasma DES concentration on patients survival	Cycle3 Day28 (each cycle is 28 days)
Secondary	plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle6 Day28 (each cycle is 28 days)
Secondary	plasma DES concentration	influence of plasma DES concentration on patients survival	Cycle6 Day28 (each cycle is 28 days)