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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
Sponsor:
Collaborator:
Apices Soluciones S.L.
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

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, 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
Experimental: Cabozantinib
Cabozantinib 40 mg p.o. once daily in 28-day cycles.
Drug: Cabozantinib
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
    Complete Response (CR) evaluated by RECIST 1.1 criteria according to investigator criteria.

  3. Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
    Partial Response (PR) evaluated by RECIST 1.1 criteria according to investigator criteria.

  4. Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
    Stable Disease (SD) evaluated by RECIST 1.1 criteria according to investigator criteria.

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Documented histological or cytological diagnosis of renal cell cancer.
  2. Measurable disease per RECIST 1.1 as determined by the investigator.
  3. Metastatic disease.
  4. Patient must have signed the informed consent document.
  5. Capable of understanding and complying with the protocol requirements.
  6. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2.
  7. Patients aged >70 years old with Society of Geriatric Oncology (SIOG) defined fragile population or patients >75 years with or without SIOG defined fragility.
  8. No previous treatment for Metastatic Renal Cell Carcinoma (mRCC)
  9. Adequate organ function based on standard laboratory tests including haematology, serum chemistry, lipids, coagulation, thyroid function, and urinalysis.
  10. 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.

Exclusion Criteria:

  1. Previous treatment for mRCC.
  2. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before inclusion.
  3. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 3 months before inclusion.
  4. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
  5. Chronic treatment with corticosteroids or other immunosuppressive agents
  6. 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.
  7. Major surgery within 2 months before inclusion.
  8. Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 msec within 10 days before inclusion.
  9. Inability to swallow tablets or capsules.
  10. Previously identified allergy or hypersensitivity to components of the study treatment formulation.
  11. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Isabel Grau +34610286915 trialmanager@sogug.es

Locations
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Spain
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
Lugo, Spain
Contact: Natalia Fernandez         
Principal Investigator: Natalia Fernandez, MD         
Hospital Infanta Sofia Recruiting
Madrid, Spain
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    macliment@fivo.org   
Principal Investigator: Miguel A Climent, MD         
Hospital Doctor Peset Recruiting
Valencia, Spain
Contact: Dolores Torregrosa         
Principal Investigator: Dolores Torregrosa, MD         
Hospital Universitario La Fe Recruiting
Valencia, Spain
Contact: Regina Gironés, MD         
Principal Investigator: Regina Gironés, MD         
Hospital Clinico de Valladolid Recruiting
Valladolid, Spain
Contact: Ricardo Sanchez         
Principal Investigator: Ricardo Sanchez, MD         
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Apices Soluciones S.L.
Investigators
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Principal Investigator: Miguel A Climent, MD FIVO
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Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT04134390    
Other Study ID Numbers: CABOMAYOR
2019-001639-30 ( EudraCT Number )
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spanish Oncology Genito-Urinary Group:
fragile
renal carcinoma
old age
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases