Old Age; DebilityPhase 2CABOMAYORNCT04134390
Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study
A Phase 2 study testing Cabozantinib in people with Old Age; Debility and Renal Carcinoma Metastatic, run by Spanish Oncology Genito-Urinary Group at 10 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Old Age; Debility, Renal Carcinoma Metastatic
- What is being tested?
- Cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesSpain
- Study dates
- 17 Feb 2020to 22 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Documented histological or cytological diagnosis of renal cell cancer.
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Metastatic disease.
- Patient must have signed the informed consent document.
- Capable of understanding and complying with the protocol requirements.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2.
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- Patients aged >70 years old with Society of Geriatric Oncology (SIOG) defined fragile population or patients >75 years with or without SIOG defined fragility.
- No previous treatment for Metastatic Renal Cell Carcinoma (mRCC)
- Adequate organ function based on standard laboratory tests including haematology, serum chemistry, lipids, coagulation, thyroid function, and urinalysis.
- Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.
Who cannot join
- Previous treatment for mRCC.
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before inclusion.
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 3 months before inclusion.
- Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors or low molecular weight heparins (LMWH).
- Chronic treatment with corticosteroids or other immunosuppressive agents
- Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders, Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation, Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 3 months before inclusion, Cavitating pulmonary lesion(s) or known endobronchial disease manifestation and/or Lesions invading major pulmonary blood vessels.
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- Major surgery within 2 months before inclusion.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 msec within 10 days before inclusion.
- Inability to swallow tablets or capsules.
- Previously identified allergy or hypersensitivity to components of the study treatment formulation.
- Diagnosis of another malignancy within 2 years before inclusion, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital de Ciudad Real
Ciudad Real
ICO L'Hospitalet
L'Hospitalet de Llobregat
Hospital Insular de Gran Canarias
Las Palmas de Gran Canaria
Hospital Lucus Augusti
Lugo
Hospital Infanta Sofia
Madrid
Hospital Universitario de Donostia
San Sebastián
Fundación Instituto Valenciano de Oncologia
Valencia, 46009
Hospital Doctor Peset
Valencia
Hospital Universitario La Fe
Valencia
Hospital Clinico de Valladolid
Valladolid
About this study
Official title: Pilot Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study
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.
- Conditions
- Old Age; Debility, Renal Carcinoma Metastatic
- Being tested
- Cabozantinib
- Keywords
- fragile, renal carcinoma, old age
- Medical subject headings
- Frailty, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib | Experimental | Cabozantinib 40 mg p.o. once daily in 28-day cycles. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Complete Response (CR) evaluated by Evaluation Criteria In Solid Tumors (RECIST) 1.1 according to investigator criteria.
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (6)
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.
Measured: Up to 24 months
Disease Control Rate (DCR)
Complete Response (CR) evaluated by RECIST 1.1 criteria according to investigator criteria.
Measured: Up to 24 months
Disease Control Rate (DCR)
Partial Response (PR) evaluated by RECIST 1.1 criteria according to investigator criteria.
Measured: Up to 24 months
Disease Control Rate (DCR)
Stable Disease (SD) evaluated by RECIST 1.1 criteria according to investigator criteria.
Measured: 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
Measured: 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
Measured: Since the patient's study enrolment until death assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start17 Feb 2020
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Miguel A Climent, MD, Principal investigator, FIVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134390
- Sponsor's protocol ID
- CABOMAYOR
- Other IDs
- 2019-001639-30, 2019
- Acronym
- CABOMAYOR
- Status last verified
- Dec 2023
- First submitted
- 15 Oct 2019
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study
- ClinicalTrials.gov ID
- NCT04134390
- Acronym / sponsor ID
- CABOMAYOR / CABOMAYOR
- Conditions
- Old Age; Debility, Renal Carcinoma Metastatic
- Keywords
- fragile, renal carcinoma, old age
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib | Experimental | Drug: CabozantinibCabozantinib 40 mg p.o. once daily in 28-day cycles. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Documented histological or cytological diagnosis of renal cell cancer.
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Metastatic disease.
- Patient must have signed the informed consent document.
- Capable of understanding and complying with the protocol requirements.
Key exclusion criteria (11 listed)
- Previous treatment for mRCC.
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before inclusion.
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 3 months before inclusion.
- Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors or low molecular weight heparins (LMWH).
- Chronic treatment with corticosteroids or other immunosuppressive agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibSubjects 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 | Drug | Cabozantinib |
Primary outcome
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.
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Progression Free Survival (PFS)
Time frame: Since the patient's study enrolment until patient progression, assessed up to 24 months
Overall Survival (OS)
Time frame: Since the patient's study enrolment until death assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel A Climent, MD principal investigator
FIVO
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabozantinib in people with Old Age; Debility and Renal Carcinoma Metastatic, run by Spanish Oncology Genito-Urinary Group at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.