Status:
COMPLETED
Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study
Lead Sponsor:
Spanish Oncology Genito-Urinary Group
Collaborating Sponsors:
Apices Soluciones S.L.
Conditions:
Old Age; Debility
Renal Carcinoma Metastatic
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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 assoc...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04134390
Start Date
February 17 2020
End Date
November 22 2023
Last Update
January 9 2024
Active Locations (10)
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1
Hospital de Ciudad Real
Ciudad Real, Spain
2
ICO L'Hospitalet
L'Hospitalet de Llobregat, Spain
3
Hospital Insular de Gran Canarias
Las Palmas de Gran Canaria, Spain
4
Hospital Lucus Augusti
Lugo, Spain