Ignite Creation Date:
2024-05-06 @ 1:49 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04134390
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2019-10-15
Brief Title:
Study of Cabozantinib Efficacy Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients CABOMAYOR Study
Sponsor:
Spanish Oncology Genito-Urinary Group
Organization:
Spanish Oncology Genito-Urinary Group
Study Overview
Official Title:
Pilot Study of Cabozantinib Efficacy Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients CABOMAYOR Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CABOMAYOR
Brief Summary:
Aged fragile patients are not usually included in clinical trials and efficacy and tolerability of the different available treatments in this population are unknown
Conversely ageing has been associated with a decrease in the efficacy of immune checkpoint inhibitors due to a decline in the effectiveness of the immune system immunosenescence In the Checkmate 025 trial comparing nivolumab with everolimus the Hazard Ratio HR in patients older than 75 years old favoured everolimus 123 066-231 Thus TKis might be a better treatment option for this population However the absence of data and concerns about possible secondary effects associated can preclude clinicians to treat aged fragile patients with cabozantinib A pilot phase II trial would help to have data on safety and efficacy of cabozantinib in this aged fragile population
In METEOR trial around 60 of patients reduced the dose of cabozantinib because of toxicity and tolerance problems It is suspected that the efficacy of cabozantinib in the population to be included in this trial aged and fragile will be similar to that observed in CABOSUN trial disease control rate around 75 However there is no information available in this group of patients On the other hand in the 75 years old subgroup within the METEOR trial 37 discontinued due to adverse events 85 needed dose reductions and median average daily dose was 336 mg For this reason the cabozantinib initial dose chosen for patients to be included in this study is 40 mgday
Conversely ageing has been associated with a decrease in the efficacy of immune checkpoint inhibitors due to a decline in the effectiveness of the immune system immunosenescence In the Checkmate 025 trial comparing nivolumab with everolimus the Hazard Ratio HR in patients older than 75 years old favoured everolimus 123 066-231 Thus TKis might be a better treatment option for this population However the absence of data and concerns about possible secondary effects associated can preclude clinicians to treat aged fragile patients with cabozantinib A pilot phase II trial would help to have data on safety and efficacy of cabozantinib in this aged fragile population
In METEOR trial around 60 of patients reduced the dose of cabozantinib because of toxicity and tolerance problems It is suspected that the efficacy of cabozantinib in the population to be included in this trial aged and fragile will be similar to that observed in CABOSUN trial disease control rate around 75 However there is no information available in this group of patients On the other hand in the 75 years old subgroup within the METEOR trial 37 discontinued due to adverse events 85 needed dose reductions and median average daily dose was 336 mg For this reason the cabozantinib initial dose chosen for patients to be included in this study is 40 mgday
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001639-30 | EUDRACT_NUMBER | None | None |