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

  • STATUS
    Recruiting
  • End date
    Dec 6, 2023
  • participants needed
    70
  • sponsor
    Decibel Therapeutics
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Updated on 6 April 2022
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Summary

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.

Description

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.

Details
Condition Ototoxicity
Treatment Placebo, DB-020
Clinical Study IdentifierNCT04262336
SponsorDecibel Therapeutics
Last Modified on6 April 2022

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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