Sunitinib Drug Levels and Outcomes in Kidney Cancer

NCT01711268 | Unknown

• 1 other identifier: HGWH008
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is 50mg, but many patients require a dose decrease due to side-effects. Drug levels of sunitinib vary approximately 10-fold between patients. This study will measure blood levels of sunitinib and its metabolite, and correlate these with side-effects and the response to the treatment. The study aims to establish whether blood levels change with time, and see how useful blood levels are for monitoring patients treated with sunitinib.

Conditions

Renal Cell Carcinoma

Keywords

Sunitinib; Renal Cell Carcinoma; Therapeutic Drug Monitoring; Pharmacokinetic; Treatment toxicity

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (time on sunitinib treatment)

  This duration extends from the date the patient starts sunitinib until the date sunitinib is abandoned. The group with sunitinib concentration below the population median are expected to have a median Time to Treatment Failure (TTF) of approximately 8 months, compared with 14 months in those with sunitinib concentration above the population median.

  Sunitinib duration (median)

Secondary Outcomes (4)

• Toxicity

  Every 6 weeks

• Overall survival

  2 years

• Progression-free survival

  2 years

• Time to second line therapy

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults being treated with sunitinib monotherapy for metastatic renal cell carcinoma

You may qualify if:

• Metastatic renal cell cancer treated with single agent sunitinib
• No known primary liver disease and no other severe or uncontrolled concurrent medical conditions
• Signed informed consent

You may not qualify if:

• Patients who are unable to sign informed consent
• Patients unable to give blood
• Patients who are pregnant, nursing or not using an effective contraception method
• Patients who had bone-marrow-transplantation prior to sunitinib treatment

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Crown Princess Mary Cancer Centre, Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Howard Gurney, MBBS, FRACP

  Crown Princess Mary Cancer Centre, Westmead

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Howard Gurney, MBBS, FRACP

CONTACT

+61298455200; howard.gurney@sydney.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: October 22, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 15, 2014

Record last verified: 2014-05

Locations

AU (1)