Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-21

Study Completion Date

2023-05-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate whether DB-020 administered via an injection in the middle ear prevents hearing loss in participants who will receive high doses of cisplatin as part of their treatment for cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

NCT05628233

Hearing Loss Ototoxic

COMPLETED PHASE2

Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin

NCT00477607

Ototoxicity Unspecified Adult Solid Tumor

COMPLETED PHASE2/PHASE3

Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

NCT04226456

Ototoxic Hearing Loss Ototoxic Hearing Loss, Bilateral Ototoxicity +1 more

TERMINATED PHASE4

Protection From Cisplatin Ototoxicity by Lactated Ringers

NCT00584155

Hearing Loss

WITHDRAWN PHASE1

NAC to Prevent Cisplatin-induced Hearing Loss

NCT02094625

Neuroectodermal Tumors, Primitive Liver Neoplasms Osteosarcoma +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cisplatin is a widely used and effective chemotherapy in the treatment of adult and pediatric solid tumors, including bladder, testicular, head and neck, and lung cancers. Serious side effects of cisplatin treatment include ototoxicity. To date, no approved therapy to prevent or treat ototoxicity exists for people receiving cisplatin treatment, which remains the most common dose-limiting side effect associated with cisplatin administration.

Participants who will be undergoing cancer treatment with high doses of cisplatin every 21 or 28 days will receive IT injection with one ear receiving DB-020 and one ear receiving placebo during each administration. The study will comprise 2 parts. In Part A, eligible participants will be randomized to one of two doses of DB-020. In Part B, participants will be treated with a single dose of DB-020, as selected from data collected in Part A. In both Parts A and B, the ear receiving DB-020 or placebo will be randomized. The choice of dose in Part B will depend on the data from Part A. If appropriate safety and efficacy is observed at either dose level, the Sponsor has the option of dosing at one of these concentrations either unilaterally (ie, with placebo administered in the contralateral ear) or bilaterally (ie, open-label DB-020 administered to both ears) in Part B.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ototoxicity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part A: DB-020 12% right ear/placebo left ear; DB-020 12% left ear/placebo right ear; DB-020 25% right ear/placebo left ear; DB-020 25% left ear/placebo right ear on Day 1 of every 21 or 28 day cisplatin cycle for up to 6 cycles until cisplatin administration is discontinued

Part B: DB-020 12% both ears or DB-020-25% both ears on Day 1 of every 21 or 28 day cisplatin cycle for up to 6 cycles until cisplatin administration is discontinued

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DB-020 for Injection, 12%/placebo

dosage

Group Type ACTIVE_COMPARATOR

DB-020

Intervention Type DRUG

Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water

Placebo

Intervention Type DRUG

Injectable sterile viscous solution of sodium hyaluronate in sodium chloride

DB-020 for Injection, 25%/placebo

dosage

Group Type ACTIVE_COMPARATOR

DB-020

Intervention Type DRUG

Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water

Placebo

Intervention Type DRUG

Injectable sterile viscous solution of sodium hyaluronate in sodium chloride

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DB-020

Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water

Intervention Type DRUG

Placebo

Injectable sterile viscous solution of sodium hyaluronate in sodium chloride

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sodium Thiosulfate (STS) pentahydrate formulated in sodium hyaluronate sodium hyaluronate in sodium chloride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ability to communicate with medical team and staff, willingness to participate in the study, give written informed consent, comply with the study restrictions
* Adults aged 18 years, inclusive, or older
* Treatment for cancer with Intervenous cisplatin once every 21 or 28 days
* Plan to receive a minimum cumulative dose of cisplatin of ≥ 280 mg/m2 over at least three cycles
* Concomitant use of other chemotherapy and radiation is permitted except investigational agents and/or radiation \> 35 Grays involving the cochlear area
* Male patients, their female partner(s), and female patients of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last study drug administration.
* Male and female patients who consider themselves abstinent, and who agree to remain abstinent during the study and for 90 days after the last study drug administration
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Anticipated survival \> 1 year
* Normal or not clinically significant otoscopic findings in both ears
* Patient has read, understood, and voluntarily signed the informed consent form.

Exclusion Criteria

* Female or male patients with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after last dose of study drug
* Prior treatment with a cisplatin regimen
* Signs of disturbed integrity of the tympanic membrane on otoscopy or tympanometry
* History of congenital hearing loss
* History of otological surgery (excluding myringotomy tubes or simple tympanoplasty)
* History of sudden hearing loss
* History of conductive hearing loss \> 10 decibels at 2 frequencies in either ear
* Diagnosis of Meniere's disease
* Diagnosis of autoimmune middle ear disease
* Hearing loss greater than (not including) 45 decibels Hearing Loss averaged at 6 and 8 kilohertz in either ear
* Asymmetry in hearing thresholds between left and right ear equal to or exceeding 20 decibels at any single frequency or 10 decibels at any 3 consecutive frequencies, up to and including 8 kilohertz
* Previous radiation exposure \> 35 Grays to all or part of the cochlea
* Consumption of \> 6 grams of salicylate or \> 5 grams of acetaminophen (paracetamol) per day for the past month, or aminoglycoside use in the past month
* Use of any investigational drug or device within 30 days prior to the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, if known, whichever time is longer
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and/or allergy to the excipients of the study medications
* Presence of hepatitis C antibody with reflex hepatitis C virus (HCV) RNA testing (if anti-HCV is positive), hepatitis B surface antigen, or HIV antibodies 1 and 2

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No