Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study (CABOMAYOR)
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|ClinicalTrials.gov Identifier: NCT04134390|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : March 2, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Old Age; Debility Renal Carcinoma Metastatic||Drug: Cabozantinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cabozantinib 40 mg per os (p.o.) once daily in 28-day cycles. Dose can be escalated to 60 mg to avoid suboptimal exposure to the drug if 40 mg is considered tolerated. If the dose of 40 mg is not tolerated, a de-escalation to 20 mg, temporary interruption, or stopping cabozantinib will be possible.|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study|
|Actual Study Start Date :||February 17, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Cabozantinib 40 mg p.o. once daily in 28-day cycles.
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
- Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]Complete Response (CR) evaluated by Evaluation Criteria In Solid Tumors (RECIST) 1.1 according to investigator criteria.
- Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]Partial Response (PR) evaluated by Evaluation Criteria In Solid Tumors (RECIST) 1.1 according to investigator criteria.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 24 months ]Adverse Events (AEs) experienced by patients. AEs will be assessed according to National Cancer Institute-Common Terminology Criteria (NCI-CTC) v 5.0 criteria.
- Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]Complete Response (CR) evaluated by RECIST 1.1 criteria according to investigator criteria.
- Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]Partial Response (PR) evaluated by RECIST 1.1 criteria according to investigator criteria.
- Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]Stable Disease (SD) evaluated by RECIST 1.1 criteria according to investigator criteria.
- Progression Free Survival (PFS) [ Time Frame: Since the patient's study enrolment until patient progression, assessed up to 24 months ]Time in months since the patient's study enrolment until patient progression according to RECIST 1.1 criteria
- Overall Survival (OS) [ Time Frame: Since the patient's study enrolment until death assessed up to 24 months ]It is time in months since the patient's study enrolment until death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134390
|Contact: Isabel Graufirstname.lastname@example.org|
|Hospital de Ciudad Real||Not yet recruiting|
|Ciudad Real, Spain|
|Contact: Juan Carlos Villa|
|Principal Investigator: Juan Carlos Villa, MD|
|ICO L'Hospitalet||Not yet recruiting|
|L'Hospitalet De Llobregat, Spain|
|Contact: Lucía Heras|
|Principal Investigator: Lucía Heras, MD|
|Hospital Insular de Gran Canarias||Not yet recruiting|
|Las Palmas De Gran Canaria, Spain|
|Contact: Elisenda Francina Llabrés Valentí|
|Hospital Lucus Augusti||Recruiting|
|Contact: Natalia Fernandez|
|Principal Investigator: Natalia Fernandez, MD|
|Hospital Infanta Sofia||Recruiting|
|Contact: Francisco Zambrana, MD|
|Principal Investigator: Francisco Zambrana, MD|
|Hospital Universitario de Donostia||Not yet recruiting|
|San Sebastián, Spain|
|Contact: Laura Basterretxea, MD|
|Principal Investigator: Laura Basterretxea, MD|
|Fundación Instituto Valenciano de Oncologia||Recruiting|
|Valencia, Spain, 46009|
|Contact: Miguel A Climent, MD +34 961114050 email@example.com|
|Principal Investigator: Miguel A Climent, MD|
|Hospital Doctor Peset||Recruiting|
|Contact: Dolores Torregrosa|
|Principal Investigator: Dolores Torregrosa, MD|
|Hospital Universitario La Fe||Recruiting|
|Contact: Regina Gironés, MD|
|Principal Investigator: Regina Gironés, MD|
|Hospital Clinico de Valladolid||Recruiting|
|Contact: Ricardo Sanchez|
|Principal Investigator: Ricardo Sanchez, MD|
|Principal Investigator:||Miguel A Climent, MD||FIVO|