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Correlating Renal Cell Cancer Treatment Efficacy With Sunitinib Therapeutic Levels and Outcomes

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

Correlating Renal Cell Cancer Treatment Efficacy With Sunitinib Therapeutic Levels and Outcomes

Rationale: Sunitinib is an oral multi-targeted tyrosine kinase inhibitor used for first-line
systemic therapy in metastatic renal cell carcinoma. It is metabolised to a
pharmacologically active metabolite, SU012662, which is of equal potency to the parent
compound. At a standard 50mg daily dose, variability in plasma levels between patients is
approximately ten-fold. In clinical trials, over 30% of patients require a dose reduction
due to toxicity. However, some patients can tolerate up to 100mg without excessive toxicity.
It is unknown if sunitinib clearance changes with time. Pre-clinical experiments observed
tyrosine kinase inhibition at a plasma concentration of 50-100ng/ml.

Design: This is a prospective non-randomized, Phase II clinical study. Decision to treat
patients with single-agent sunitinib is pre-determined by treating specialists before
entering this study. Toxicity and trough sunitinib/metabolite levels will be measured every
six weeks during treatment.

Aim: This study will prospectively examine the relationship between steady-state trough
levels of sunitinib/metabolites and the time on treatment, in addition to changes in trough
levels over time. Trough levels will also be correlated with other measures of efficacy and
treatment-related toxicity. Furthermore, we aim to confirm that the putative target of
50ng/ml correlates with toxicity and time on sunitinib.

Inclusion Criteria:

- Metastatic renal cell cancer treated with single agent sunitinib

- No known primary liver disease and no other severe or uncontrolled concurrent medical

- Signed informed consent

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time to treatment failure (time on sunitinib treatment)

Outcome Description:

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.

Outcome Time Frame:

Sunitinib duration (median)

Safety Issue:


Principal Investigator

Howard Gurney, MBBS, FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Crown Princess Mary Cancer Centre, Westmead


Australia: Human Research Ethics Committee

Study ID:




Start Date:

May 2012

Completion Date:

December 2014

Related Keywords:

  • Renal Cell Carcinoma
  • Sunitinib
  • Renal Cell Carcinoma
  • Therapeutic Drug Monitoring
  • Pharmacokinetic
  • Treatment toxicity
  • Carcinoma
  • Carcinoma, Renal Cell