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A Compassionate Use Program to Provide Access to Sodium Thiosulfate

Primary Purpose

Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma

Status

Available

Phase

Locations

Turkey

Study Type

Expanded Access

Intervention

Sodium Thiosulfate (STS)

About this trial

This is an expanded access trial for Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma focused on measuring Cisplatin, Hearing Loss, Hepatoblastoma

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All Sexes

Inclusion Criteria:

I-1. Children older than 1 month and younger than 18 years of age who had standard-risk hepatoblastoma that had not been treated previously with STS and receive cisplatin.

I-2. A written informed consent was provided from all the patients and/or parents or legal guardians of children.

Exclusion Criteria:

E-1. Any previous participation in an STS clinical trial. E-2. Participation in another clinical study with an investigational product during the most recent chemotherapy course.

E-3. Patients with a known hypersensitivity to STS or any of the excipients of the product.

E-4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to STS treatment.

E-5. Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding alopecia.

E-6. Breast feeding or pregnant women.

Sites / Locations

Ankara University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04132882

First Posted

October 16, 2019

Last Updated

September 15, 2021

Sponsor

TRPHARM

Collaborators

Fennec Pharma

1. Study Identification

Unique Protocol Identification Number

NCT04132882

Brief Title

A Compassionate Use Program to Provide Access to Sodium Thiosulfate

Official Title

A Compassionate Use Program to Provide Access to Sodium Thiosulfate for the Protection From Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma

Study Type

Expanded Access

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TRPHARM

Collaborators

Fennec Pharma

4. Oversight

5. Study Description

Brief Summary

This is a CUP which is designed to provide treatment access of STS to pediatric patients for the protection from Cisplatin-Induced Hearing Loss in children who had standard-risk hepatoblastoma. Approximately 10 patients will be treated as part of this program as specified below: Sodium Thiosulfate vials i.v. 80 mg/mL. This Compassionate Use Program for STS will consist of 2 phases: Screening: Patients will only be able to participate in this CUP if they meet the eligibility criteria. Treatment: Any clinical assessments, physical examinations, and dosage changes will be determined by the treating physician as per local standard medical practice. All serious adverse events (SAEs) will be reported. All related non-serious adverse events (AEs) will be reported where "related" means any event where a causal relationship between STS and the event is at least, a reasonable possibility. All non-serious AEs leading to dose modification or discontinuation will be reported. Pregnancies, outcomes of pregnancies, and exposure through breastfeeding will also be reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma

Keywords

Cisplatin, Hearing Loss, Hepatoblastoma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sodium Thiosulfate (STS)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: I-1. Children older than 1 month and younger than 18 years of age who had standard-risk hepatoblastoma that had not been treated previously with STS and receive cisplatin. I-2. A written informed consent was provided from all the patients and/or parents or legal guardians of children. Exclusion Criteria: E-1. Any previous participation in an STS clinical trial. E-2. Participation in another clinical study with an investigational product during the most recent chemotherapy course. E-3. Patients with a known hypersensitivity to STS or any of the excipients of the product. E-4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to STS treatment. E-5. Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding alopecia. E-6. Breast feeding or pregnant women.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Serdar Altinel

Phone

00902123863149

serdar.altinel@trpharm.com

Facility Information:

Facility Name

Ankara University School of Medicine

City

Ankara

Country

Turkey

Individual Site Status

Available

12. IPD Sharing Statement

Learn more about this trial

A Compassionate Use Program to Provide Access to Sodium Thiosulfate

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