Renal cell carcinoma Renal cell carcinoma
Conditions
Interventions
Cabozantinib is orally administered once daily on an empty stomach.
Sponsors
Hongo Fumiya
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years at the time of informed consent (Regardless of genders) 2. Patients with clinically or histologically diagnosed as clear cell renal cell carcinoma. However, they who have been histologically diagnosed as non-clear cell renal cell carcinoma are excluded. 3. Patients with radiographic evidence of at least one measurable bone target lesion. 4. Patients with Karnofsky Performance Status (KPS) score >= 70% 5. Patients with adequate organ and bone marrow function as assessed within 14 days prior to Week 1 Day 1. The investigator or subinvestigator determine eligibility for study registration with reference to the following: (a) Absolute neutrophil count (ANC) >= 1,500/mm 3 (b) Platelet count: >= 100,000/mm 3 (c) Hemoglobin >= 9 g/dL (d) ALT and AST = 30 mL/min (g) UPCR: <= 1 mg/mg Cr 6. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. 7. Patients who can sign and date a written informed consent form prior to enrollment in the study 8. Patients expected to survive for at least 6 months at the time of informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with radiotherapy to a target lesion of bone metastasis or who require radiotherapy to a target lesion at Week 1 Day 1 2. Patients with brain or central nervous system metastases (Patients who have been adequately treated with radiotherapy radiosurgery, or surgery (resection or biopsy of brain metastases), have not required corticosteroids for at least 14 days prior to Week1 Day1, and are clinically stable for at least 28 days prior to Week1 Day1 may be enrolled). 3. Patients with currently or recently applicable to the following uncontrolled significant medical condition (However, are not limited to): (a) Cardiovascular disorders (b) Gastrointestinal disorders with a high risk of perforation or fistula (c) Clinically significant hematuria, hematemesis, hemoptysis > 2.5 mL, or other serious bleeding events (For example, pulmonary hemorrhage) within 90 days prior to Week 1 Day 1. (d) Signs of cavitary lung lesions or endobronchial disease (e) Lesions invading major pulmonary vessels (f) Human immunodeficiency virus positive or acquired immunodeficiency syndrome-related illness (g) Active Hepatitis B or C (h) Clinically significant disease, etc. (Active infection requiring systemic treatment, serious unhealed trauma/ulcer/fracture, etc.) 4. Patients with adverse events which occurred with the past treatment that have not resolved to baseline or Grade =< 1 according to CTCAE version 5.0., unless clinically insignificant or stable on supportive care. 5. Patients who had major surgery within 42 days and nephrectomy within 28 days prior to Week 1 Day 1 (complete wound healing and even in the absence of ongoing postoperative complications). 6. Pregnant or breastfeeding women, or patients who are unable to prevent pregnancy during the study and for 4 months after the last dose. 7. Patients who are inability to swallow tablets 8. Patients previously treated with cabozantinib 9. Patients with a history of allergy or hypersensitivity to any ingredients of cabozantinib 10. Patients with a previous diagnosis of malignancy other than renal cell carcinoma and residual disease confirmed within 2 years prior to Week 1 Day 1. excluding mucosal cancers cured or possibly cured by regional resection (esophageal, stomach, and cervical cancer; non-melanoma skin cancer; bladder cancer, etc) 11. Patients have participated in any clinical study or interventional study within 30 days prior to Week 1 Day 1. 12. Other patients considered ineligible for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response rate of bone target lesion using MDA criteria by IRC assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| OS Disease control rate of bone target lesions using MDA criteria by IRC assessment Objective Response Rate of bone target lesions based on RECIST 1.1 by IRC assessment BMFS based on RECIST 1.1 using MDA criteria and RECIST 1.1 by IRC assessment Progression-free survival (PFS: Progression-free survival) based on RECIST 1.1 by Investigators assessment Overall Response Rate and disease control rate based on RECIST 1.1 by investigators assessment Frequency and period until appearance of SSE DOR of bone target lesions based on MDA criteria and RECIST 1.1 by IRC assessment Period until it becomes effective based on MDA criteria and RECIST 1.1 by IRC assessment Frequency of adverse events EQ-5D-5 L Range of Motion, Self-Care, Activities of Daily Living, Pain/Discomfort, Anxiety/Depression and Changes in Overall Health as Assessed Changes in bone metabolism markers (BSAP, CTX, P1NP) Changes in plasma biomarkers (HGF, MET, RANKL, IL-6, OPG) | — |
Contacts
Public ContactFumiya Hongo
University Hospital Kyoto Prefectural University of Medicine
Outcome results
None listed