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, 1.23 (0.66-2.31). 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 33,6 mg. For this reason, the cabozantinib initial dose chosen for patients to be included in this study is 40 mg/day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Subjects will receive cabozantinib 40mg p.o. as long as they continue to experience clinical benefit or until unacceptable toxicity, the need for alternative anticancer treatment, or other reasons for treatment discontinuation
Hospital de Ciudad Real
Ciudad Real, Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Spain
Hospital Insular de Gran Canarias
Las Palmas de Gran Canaria, Spain
Hospital Lucus Augusti
Lugo, Spain
Hospital Infanta Sofia
Madrid, Spain
Hospital Universitario de Donostia
San Sebastián, Spain
Fundación Instituto Valenciano de Oncologia
Valencia, Spain
Hospital Doctor Peset
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Clinico de Valladolid
Valladolid, Spain
Objective Response Rate (ORR)
Complete Response (CR) evaluated by Evaluation Criteria In Solid Tumors (RECIST) 1.1 according to investigator criteria.
Time frame: Up to 24 months
Objective Response Rate (ORR)
Partial Response (PR) evaluated by Evaluation Criteria In Solid Tumors (RECIST) 1.1 according to investigator criteria.
Time frame: Up to 24 months
Incidence of Treatment-Emergent Adverse Events
Adverse Events (AEs) experienced by patients. AEs will be assessed according to National Cancer Institute-Common Terminology Criteria (NCI-CTC) v 5.0 criteria.
Time frame: Up to 24 months
Disease Control Rate (DCR)
Complete Response (CR) evaluated by RECIST 1.1 criteria according to investigator criteria.
Time frame: Up to 24 months
Disease Control Rate (DCR)
Partial Response (PR) evaluated by RECIST 1.1 criteria according to investigator criteria.
Time frame: Up to 24 months
Disease Control Rate (DCR)
Stable Disease (SD) evaluated by RECIST 1.1 criteria according to investigator criteria.
Time frame: Up to 24 months
Progression Free Survival (PFS)
Time in months since the patient's study enrolment until patient progression according to RECIST 1.1 criteria
Time frame: Since the patient's study enrolment until patient progression, assessed up to 24 months
Overall Survival (OS)
It is time in months since the patient's study enrolment until death
Time frame: Since the patient's study enrolment until death assessed up to 24 months
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