IRCT20220614055167N4
Not yet recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tabriz University of Medical Sciences
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 4
Study of effectiveness of topical phenytoin in healing of diabetic foot ulcersCTRI/2024/02/062560Tata Motors Hospital
Not yet recruiting
Phase 1
Safety and efficacy and of sodium pentaborate pentahydrate in people with overweight and obesityOverweight and obesity.Overweight and obesityIRCT20220614055167N3Tabriz University of Medical Sciences120
Completed
Phase 2
A clinical trial of efficacy and safety of sodium phenylbutyrate in progressive familial intrahepatic cholestasis type 2progressive familial intrahepatic cholestasis type 2JPRN-UMIN000024753Japan Agency for Medical Research and Development6
Completed
Phase 2
Evaluation of safety and efficacy of two types of thread lift for facial rejuvenation.skin rejuvenation.IRCT2016120720514N6Aftab Froozan Arya Organization20
Completed
Phase 3
Evaluation of the efficacy and safety of the potassium citrate tablet of immediate release vs Acalka® in urolithiasis in adults.Male Urogenital DiseasesRenal urolithiasisUrolithiasisNephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesRPCEC00000333Oriente Pharmaceutical Laboratory Company