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Renal Cell CarcinomaPhase 1/2NCT05798455

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

A Phase 1/2 study testing Sodium Pentaborate in people with Renal Cell Carcinoma, run by Tabriz University of Medical Sciences at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Sodium Pentaborate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIran
Study dates
22 May 2023to 22 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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).
  • Individuals with evidence of active malignancy other than RCC (except for curable early-stage cancer such as resected skin cancers and/or completely resected prostate cancer).

Trial locations and contacts

1 site in 1 country.

Saeid Safiri, PhD contact

+984133342178

saeidsafiri@gmail.com

Iran1 site

  • Imam Reza hospital and Clinic of Salamat

    Tabriz, East Azarbayejan, 5166614766

Other trials in Iran

About this study

Official title: 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

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

Read the detailed description

There is an increasing trend in the burden of renal cell carcinoma (RCC) globally. Although different therapies like tyrosine kinase inhibitors, ablative therapy, surgery, and immunotherapy have been suggested for RCC, they are not cost-effective. The present study will be conducted as an open-label, phase Ib/II study consisting of a dose-escalation stage followed by a cohort expansion stage. The trial will be conducted in the medical centers affiliated to the Tabriz University of Medical Sciences. Patients 18 years or older presenting with histologically confirmed RCC with a clear-cell component, that progressed to the advanced or metastatic stage will be recruited. The dose-escalation stage will determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of sodium pentaborate pentahydrate. One oral sodium pentaborate pentahydrate capsule once daily will be considered for evaluation in 21-day treatment cycles: 500 mg, 1000 mg, and 1500 mg. Subjects will accrue in escalation cohorts of 3-6 subjects using a "3 plus 3" design and dosing will begin at the 500 mg dose level of sodium pentaborate pentahydrate. During this stage, the decision to open a new cohort will be made when all subjects have been followed for at least 21 days following the first dose of sodium pentaborate pentahydrate(defined as the dose-limiting toxicity (DLT) Evaluation Period). In the dose-expansion stage, we will further assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of NaB in RCC using the recommended dose and schedule as determined in the dose-escalation stage. The primary objectives for the dose-escalation stage and dose-expansion stage will be to determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent expansion stage and to evaluate the preliminary efficacy of the sodium pentaborate pentahydrate by estimating the objective response rate, respectively. The investigator will assess each subject continuously to evaluate for potential new or worsening adverse events.

Being tested
Sodium Pentaborate
Keywords
Renal Cell Carcinoma, Sodium pentaborate pentahydrate
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium PentaborateDrug

    Also called Sodium pentaborate pentahydrate

    Capsules containing sodium pentaborate pentahydrate 500, 1000 and 1500 mg

Study groups in NCT05798455
Study groupRoleWhat they receive
Intervention armExperimentalCapsules containing sodium pentaborate pentahydrate 500, 1000 and 1500 mg
Receives: Drug: Sodium Pentaborate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 21

  2. Objective response rate

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

    Measured: Day 21

Secondary outcomes (5)

  1. Duration of response

    Duration of response using Response Evaluation Criteria in Solid Tumors version 1.1

    Measured: Days 0, 1, and 21

  2. Progression free survival

    Progression free survival using Response Evaluation Criteria in Solid Tumors version 1.1

    Measured: Days 0, 1, and 21

  3. Disease control rate

    Disease control rate using Response Evaluation Criteria in Solid Tumors version 1.1

    Measured: Days 0, 1, and 21

  4. Overall survival

    Overall survival using Response Evaluation Criteria in Solid Tumors version 1.1

    Measured: Days 0, 1, and 21

  5. Adverse events

    Registration of adverse events in questionnaires using Response Evaluation Criteria in Solid Tumors version 1.1

    Measured: Days 0, 1, and 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start22 May 2023 (estimated)
  3. Primary completion22 May 2025 (estimated)
  4. Study completion22 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798455
Sponsor's protocol ID
70926
Status last verified
Mar 2023
First submitted
11 Mar 2023
Last updated
4 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sodium Pentaborate in people with Renal Cell Carcinoma, run by Tabriz University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Saeid Safiri, PhD (+984133342178, saeidsafiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) and/or recommended dose (time frame: Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05798455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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