C64
Conditions
Interventions
Group 1: Fotivda (Tivozanib) 890 micrograms oral or Fotivda (Tivozanib) 1340 micrograms oral
Sponsors
EUSA Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU). Age > 18 years at time of study entry Metastatic or locally advanced RCC not amenable to surgery with curative intention. intended treatment with tivozanib (decision has been prior and independent of this NIS) Measurable (according to RECIST 1.1) or non-measurable disease are deemed eligible Prior surgery or radiotherapy is allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
Exclusion criteria
Exclusion criteria: under 18 Years, not able to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of treatment-related AEs and SAEs during treatment and up to 30 days after last dose of tivozanib treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| treatment-related therapy discontinuations and hospitalizations, objective response rate, duration of response, TTP, time of tivozanib treatment, time to 2nd line treatment. Safety and efficacy in elderly and frail patients | — |
Countries
Germany
Contacts
Public ContactHayssam Zakaria
NewConceptOncology GmbH
Outcome results
None listed