Evaluation of the Safety and Efficacy of Sodium Pentaborate Pentahydrate in Patients With Advanced Renal Cell Carcinoma

NCT05798455 | Not Yet Recruiting Phase 1

• 1 other identifier: 70926
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the safety and efficacy of sodium pentaborate pentahydrate in patients with advanced renal cell carcinoma.

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma; Sodium pentaborate pentahydrate

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) and/or recommended dose

  Determination of maximum tolerated dose (MTD) and/or recommended dose using Response Evaluation Criteria in Solid Tumors version 1.1

  Day 21

• Objective response rate

  Objective response rate using Response Evaluation Criteria in Solid Tumors version 1.1

  Day 21

Secondary Outcomes (5)

• Duration of response

  Days 0, 1, and 21

• Progression free survival

  Days 0, 1, and 21

• Disease control rate

  Days 0, 1, and 21

• Overall survival

  Days 0, 1, and 21

• Adverse events

  Days 0, 1, and 21

Study Arms (1)

Intervention arm

EXPERIMENTAL

Capsules containing sodium pentaborate pentahydrate 500, 1000 and 1500 mg

Drug: Sodium Pentaborate

Interventions

Sodium Pentaborate DRUG

Capsules containing sodium pentaborate pentahydrate 500, 1000 and 1500 mg

Also known as: Sodium pentaborate pentahydrate

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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 after The last dose of adjuvant or neoadjuvant treatment has occurred.
• Karnofsky status score (KPS) 70%
• Measurable disease according to RECIST v1.1 according to the researcher
• Participants with favorable, 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.
• Adequate hematologic and organ function, based on meeting all laboratory criteria within 14 days prior to the first dose of study treatment
• 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 consistent and correct use during the study and for 5 months after the last dose of study treatment result in a lower failure rate. from 1% per year. An additional method of contraception, such as a barrier method (such as a condom), is recommended.
• A negative pregnancy test (urine or serum beta-human chorionic gonadotropin \[β-hCG\]) in screening sexually active women of childbearing potential.

You may not qualify if:

• Women who are pregnant, lactating, or planning to become pregnant within 3 months after the last dose of study drug and men who plan to father a child while enrolled in this study or within 5 months after the last dose of study drug.
• Any active central nervous system (CNS) metastases. 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)
• Prior 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 T cells or Targets 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 receipt of systemic steroid or any other form of immunosuppressive therapy within two weeks prior to the first dose of trial therapy.
• Administration of a live, attenuated vaccine within 30 days before the first dose of study treatment.
• The patient has an uncontrolled or significant intercurrent disease
• Hematuria, hematemesis, or hemoptysis of more than 0.5 teaspoons (2.5 mL) of clinically significant red blood, or other histories of significant bleeding (eg, pulmonary hemorrhage) in the 12 weeks before the first dose.
• Cavity lung lesions or known manifestations of endobronchial disease.
• The lesion invades 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 is not in the patient's best interest for participation.
• 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.

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

Study Sites (1)

Imam Reza hospital and Clinic of Salamat

Tabriz, East Azarbayejan, 5166614766, Iran

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

sodium pentaborate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Saeid Safiri, PhD

  Tabriz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saeid Safiri, PhD

CONTACT

+984133342178; saeidsafiri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: April 4, 2023
• Study Start: May 22, 2023
• Primary Completion: May 22, 2025
• Study Completion (Estimated): May 22, 2026
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)