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IRCT20220614055167N4 IRCT 2023-03-26 Tabriz University of Medical Sciences Evaluation of the safety and efficacy of sodium pentaborate pentahydrate in patients with advanced renal cell carcinoma Evaluation of the safety and efficacy of sodium pentaborate pentahydrate in patients with advanced renal cell carcinoma: An open-label single-arm phase 1b/2 trial 2023-05-22 anticipated 30 Complete https://irct.ir/trial/68685 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Advanced renal cell carcinoma. Intervention group: Capsules containing sodium pentaborate pentahydrate 500, 1000 and 1500 mg with the chemical formula B4H10Na2O12 will be used. Capsules are taken once a day. The treatment period will last for 21 days. Medicines will be prepared by Tabriz Faculty of Pharmacy.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no additional information.
public Saeid Safiri
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3332 7195 saeidsafiri@gmail.com Tabriz University of Medical Sciences scientific Saeid Safiri
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3332 7195 saeidsafiri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 18 years or older Histological confirmation of RCC with clear cell histology, including participants who may also have sarcomatoid features Advanced (not amenable to curative surgery or radiation) or metastatic disease (American Joint Committee on Cancer [AJCC] stage IV) Karnofsky status degree (KPS) 70% Participants with optimal, moderate and poor risk categories will be eligible for the study. Participants had to be stratified according to the International Metastatic RCC Database Consortium (IMDC) criteria according to favorable versus moderate versus poor risk status Sufficient blood and organ function, based on meeting all the following laboratory criteria in the 14 days before the first dose of study treatment No prior systemic therapy for RCC with the following exception: one prior adjuvant or neoadjuvant therapy for fully resectable RCC if such therapy did not contain an agent targeting vascular endothelial growth factor (VEGF) or VEGF receptors and if at least 6 months Relapse occurred after the last dose of adjuvant or neoadjuvant treatment Measurable disease according to RECIST v1.1 according to the researcher Patients who are willing and able to provide informed consent/written consent for the trial Sexually active fertile patients and their partners must agree to use highly effective methods of contraception that alone or in combination with continuous and correct use during the study and for 5 months after the last dose of study treatment results in Failure to be less than 1% per year. An additional method of contraception, such as a barrier method (such as a condom), is recommended Negative pregnancy test (urine or serum beta-human chorionic gonadotropin [β-hCG]) in screening women of reproductive potential who are sexually active. 18 years no limit Both Women who are pregnant, lactating or planning to become pregnant within 3 months after the last dose of the study drug and men who plan to have a child while enrolled in this study or within 5 months after the last dose of the study drug Any active central nervous system (CNS) metastasis. Participants with treated and stable CNS metastases for at least one month were eligible Any tumor that invades the superior vena cava (SVC), other major blood vessels, or the gastrointestinal tract. Any evidence of intratracheal or intrabronchial tumor Prior systemic therapy with VEGF, MET, AXL, KIT, or RET targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, sorafenib, lenvatinib, bevacizumab, and cabozantinib) Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug that specifically co-stimulates the cells Targets T or checkpoint routes History of autoimmune disease requiring systemic therapy (eg, using disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years Diagnosis of immunodeficiency or receiving treatment with systemic steroid or any other form of immunosuppressive therapy within two weeks before the first dose of experimental treatment. Administration of a live attenuated vaccine within 30 days before the first dose of study treatment The patient has an uncontrolled or significant intermediate disease Hematuria, hematemesis, or hemoptysis of more than 0.5 teaspoons (2.5 mL) of clinically significant red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) in the 12 weeks prior to the first dose Cavity lung lesions or known manifestations of endobronchial disease Injury to a major blood vessel including, but not limited to, the inferior vena cava, pulmonary artery, or aorta Known psychiatric or substance abuse disorders that interfere with compliance with trial requirements. History or current evidence of any condition, treatment, or laboratory abnormality that may confound the results of the trial, interfere with the patient's participation throughout the trial, or in the opinion of the treating investigator would not be in the patient's best interest to participate The participant is currently participating in a study of another investigational agent and has received study treatment or used an investigational device within 4 weeks prior to the first dose of treatment Allergy or previous hypersensitivity to the components of the studied therapeutic formulation has been identified. Patients with a history of infusion-related reactions to prior therapy may be eligible with sponsor approval if the reaction is considered mild and manageable with appropriate supportive care (eg, use of prodrugs per standard of care) Subjects with evidence of active malignancy other than RCC (except for definitively curable early-stage cancer such as resected skin cancers and/or completely resected prostate cancer) C64 Malignant neoplasm of kidney, except renal pelvis Treatment - Drugs Intervention group: Capsules containing sodium pentaborate pentahydrate 500, 1000 and 1500 mg with the chemical formula B4H10Na2O12 will be used. Capsules are taken once a day. The treatment period will last for 21 days. Medicines will be prepared by Tabriz Faculty of Pharmacy. Determination of maximum tolerated dose (MTD) and/or recommended dose. Timepoint: Days 0, 1 and 21. Method of measurement: Response Evaluation Criteria in Solid Tumors version 1.1. Determination of objective response rate. Timepoint: Days 0, 1 and 21. Method of measurement: Response Evaluation Criteria in Solid Tumors version 1.1. Duration of response. Timepoint: Days 0, 1 and 21. Method of measurement: Response Evaluation Criteria in Solid Tumors version 1.1. Progression free survival. Timepoint: Days 0, 1 and 21. Method of measurement: Response Evaluation Criteria in Solid Tumors version 1.1. Disease control rate. Timepoint: Days 0, 1 and 21. Method of measurement: Response Evaluation Criteria in Solid Tumors version 1.1. Overall survival. Timepoint: Days 0, 1 and 21. Method of measurement: Response Evaluation Criteria in Solid Tumors version 1.1. Adverse events. Timepoint: Days 0, 1 and 21. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2023-03-06 Ethics committee of Tabriz University of Medical Sciences Azadi St., Golgasht Ave., Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)