A Compassionate Use Program to Provide Access to Sodium Thiosulfate

NCT04132882 | Unknown

• 1 other identifier: TRP-STS-001
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cisplatin; Hearing Loss; Hepatoblastoma

Interventions

Sodium Thiosulfate (STS) DRUG

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TRPHARM: lead
• Fennec Pharma: collaborator

Study Sites (1)

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

AVAILABLE

MeSH Terms

Conditions

Hearing Loss; Hepatoblastoma

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Serdar Altinel

CONTACT

00902123863149; serdar.altinel@trpharm.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

TU (1)