ADONIS
Research type
Research Study
Full title
Axitinib In ADvanced / Metastatic Renal Cell CarcinOma - A Non-Interventional Study of Real World Treatment Outcomes in Patients Receiving 2nd Line Axitinib after 1st Line Sunitinib
IRAS ID
149302
Contact name
James Larkin
Contact email
Sponsor organisation
Pfizer SAS
Clinicaltrials.gov Identifier
NCT02184416, clinicaltrials.gov
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Axitinib is licensed for use in advanced kidney cancer when treatment with sunitinib or a cytokine is no longer working. The aim of this European study is to understand the safety and efficacy of axitinib in a population in-line with routine clinical practice in a real-life setting. While axitinib has been investigated in large randomised controlled trials, this study will provide further data in a wider population reflective of the broader kidney cancer population. Patients can enrol in the study when they start first-line treatment with sunitinib or when they start second-line treatment with axitinib after sunitinib treatment. Therefore the possible sequences of treatment under investigation include
- Sunitinib (prospective) – axitinib
- Sunitinib (retrospective) – axitinib
- Sunitinib – no further active treatment (supportive care)
- Sunitinib –second line treatment other than axitinib
The primary outcome measures will assess the combined progression free survival (PFS) and time to treatment failure (TTP) in patients receiving the sequence of sunitinib followed by axitinib and the PFS and TTP in patients receiving axitinib as a second-line treatment for advanced kidney cancer. In addition, the study will assess other efficacy measures and the safety and tolerability of axitinib. Quality of life (QoL) may also be assessed if permitted by local regulatory procedures. As this trial is an observation study (or non-interventional study) observing how the medicine is used as per routine clinical practice, there are no specific requirements with regards the treatment process.
The doctor will determine dosage and duration of the treatment, guided by the licenced information and according to his or her assessment of the individual needs of the patient.
If the QoL assessment is included, patients will be asked to complete a QoL questionnaire prior to starting and every month while they are receiving treatment with axitinib and at the end of treatment.REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/1066
Date of REC Opinion
5 Aug 2015
REC opinion
Further Information Favourable Opinion