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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04262336
Registration number
NCT04262336
Ethics application status
Date submitted
29/01/2020
Date registered
10/02/2020
Date last updated
6/07/2023
Titles & IDs
Public title
Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment
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Scientific title
Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Doses of DB-020 in Patients Receiving Cisplatin
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Secondary ID [1]
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1111-1243-8337
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Secondary ID [2]
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DB-020-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ototoxicity
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Condition category
Condition code
Ear
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Other ear disorders
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Injuries and Accidents
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DB-020
Treatment: Drugs - Placebo
Active Comparator: DB-020 for Injection, 12%/placebo - dosage
Active Comparator: DB-020 for Injection, 25%/placebo - dosage
Treatment: Drugs: DB-020
Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water
Treatment: Drugs: Placebo
Injectable sterile viscous solution of sodium hyaluronate in sodium chloride
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of patients with treatment-emergent Adverse Events (TEAEs) and/or abnormal changes from baseline in clinical laboratory abnormalities and/or vital signs and/or ECG assessments
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Assessment method [1]
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To investigate the safety and tolerability of DB-020 when given intratympanically to patients receiving cisplatin chemotherapy treatment
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Timepoint [1]
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From screening/baseline (Day -28 to Day -2) or day of first dose of DB-020 (Cycle 1 Day 1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Secondary outcome [1]
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Incidence of Ototoxicity measured by American Speech-Language-Hearing Association (ASHA) criteria
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Assessment method [1]
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Air conduction audiometry consists of a set of pure tones presented to the patient through small speakers in a headset, played at carrier frequencies ranging from 250 to 16,000 Hz. Pure tone thresholds are recorded for each frequency tested. Ototoxicity will be defined according to the American Speech-Language-Hearing Association (ASHA) criteria for significant ototoxic change. Significant ototoxic change must meet one of the following three criteria: (i) =20 dB decrease at any one test frequency, (ii) =10 dB decrease at any two adjacent frequencies, or (iii) loss of response at three consecutive frequencies where responses were previously obtained. The presence of ototoxicity will be calculated for each ear
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Timepoint [1]
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Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Secondary outcome [2]
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Changes from Baseline in Pure Tone Threshold Values compared to End of Treatment [Changes in Hearing]
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Assessment method [2]
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Air conduction audiometry consists of a set of pure tones presented to the patient through small speakers in a headset, played at carrier frequencies ranging from 250 to 16,000 Hz. Pure tone thresholds are recorded for each frequency tested. Higher values indicate a greater degree of hearing impairment. Changes from baseline values will be calculated for each frequency and ear as the reported pure tone threshold value minus the baseline value. A negative change from baseline indicates hearing loss
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Timepoint [2]
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Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Secondary outcome [3]
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Changes from Baseline in Tinnitus Functional Index (TFI) Total Score compared to End of Treatment [Changes in Hearing]
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Assessment method [3]
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The TFI is a 25-item self-assessment scale comprised of eight subscales (intrusiveness, sense of control, cognitive, sleep, auditory, relaxation, quality of life, and emotional) measuring the impact of tinnitus. Items are scored on a range of 0 to 10. The TFI Total Score is calculated as the mean of the 25 individual item scores multiplied by 10. The Total Score can range from 0 to 100. Higher scores indicate a greater degree of tinnitus-related impairment. Change from baseline values will be calculated as the reported TFI value minus the baseline value. A positive change from baseline indicates more tinnitus-related impairment
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Timepoint [3]
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Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Secondary outcome [4]
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Changes from Baseline in Distortion Product Otoacoustic Emission (DPOAE) Values compared to End of Treatment [Changes in Hearing]
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Assessment method [4]
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Distortion product otoacoustic emission (DPOAE) is defined as sound generated within the cochlea by stimulating the ear with two simultaneous tones of different frequency. DPOAEs serve as an objective measure of hearing sensitivity. Tones will be played from low to high frequencies (1 to 4 kHz) at soft to moderate levels to assess responses at different regions of the inner ear. DP levels will be recorded for each frequency and ear. Higher DP levels indicate more sensitive hearing. Change from baseline values will be calculated as the reported DP level value minus the baseline value. A negative change from baseline indicates less sensitive hearing
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Timepoint [4]
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Baseline (Day -5 to Day -1) and Cycle 1 Day 1 (21 or 28 day cycles) and End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Secondary outcome [5]
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Changes from Baseline in Words-in-Noise (WIN) Values compared to End of Treatment [Changes in Hearing]
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Assessment method [5]
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The WIN test is a series of trials to measure the ability to accurately recognize speech in noise. In each trial, a series of 5 words is read to the listener with the instruction to repeat each word. The number of correct responses is captured. Trials are presented at 7 signal-to-noise ratios, from 0 to 24 dB, in steps of 4 dB. WIN thresholds are then calculated for each ear using the Spearman-Kaerber method. Higher WIN thresholds indicate better word recognition. Change from baseline values will be calculated for each ear as the reported WIN threshold value minus the baseline value. A negative change from baseline indicates worse word recognition
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Timepoint [5]
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Baseline (Day -5 to Day -1) and Cycle 1 Day 1 (21 or 28 day cycles) and End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Secondary outcome [6]
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Changes from Baseline in Hearing Handicap Inventory for Adults (HHIA) Total Score compared to End of Treatment [Changes in Hearing]
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Assessment method [6]
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The Hearing Handicap Inventory for Adults (HHIA) is a 25-item self-assessment scale comprised of two subscales (emotional and social/situational) measuring the impact of hearing loss. Items are scored on a range of 0 to 4. The HHIA Total Score is calculated as the sum of the 25 individual item scores. The HHIA Total Score can range from 0 to 100. Higher scores indicate a greater degree of hearing impairment. Change from baseline values will be calculated as the reported HHIA value minus the baseline value. A positive change from baseline indicates more hearing impairment
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Timepoint [6]
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Baseline (Day -5 to Day -1) and Cycle 1 Day 1 (21 or 28 day cycles) and End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Secondary outcome [7]
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Plasma Concentrations of DB-020
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Assessment method [7]
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Timepoint [7]
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Predose and 0.25 hours prior to cisplatin administration on Cycle 1 Day 1 (21 or 28 day cycles)
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Secondary outcome [8]
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Maximum observed plasma concentration (Cmax) of free (unbound) cisplatin
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Assessment method [8]
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Timepoint [8]
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0.25 hours predose, mid-point of IV infusion, end of infusion, 0.25, 0.5, 1 & 2 hours postdose on Day 1 of each cycle (21 or 28 day cycles)
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Secondary outcome [9]
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Area under the plasma concentration-time curve (AUC 0-inf) of free (unbound) cisplatin
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Assessment method [9]
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Timepoint [9]
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0.25 hours predose, mid-point of IV infusion, end of infusion, 0.25, 0.5, 1 & 2 hours postdose on Day 1 of each cycle (21 or 28 day cycles)
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Secondary outcome [10]
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Time to reach maximum observed plasma concentration (tmax) of free (unbound) cisplatin
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Assessment method [10]
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Timepoint [10]
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0.25 hours predose, mid-point of IV infusion, end of infusion, 0.25, 0.5, 1 & 2 hours postdose on Day 1 of each cycle (21 or 28 day cycles)
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Secondary outcome [11]
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Half-life (t1/2) of plasma concentrations of free (unbound) cisplatin
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Assessment method [11]
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Timepoint [11]
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0.25 hours predose, mid-point of IV infusion, end of infusion, 0.25, 0.5, 1 & 2 hours postdose on Day 1 of each cycle (21 or 28 day cycles)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/05/2023
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Sample size
Target
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Queensland Head and Neck Cancer Centre - Woolloongabba
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Oncology and Palliative Care Research - Melbourne
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Recruitment hospital [4]
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Fiona Stanley Hospital, Clinical Trials Unit Cancer Center - Murdoch
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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3065 - Melbourne
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Kansas
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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West Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Decibel Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04262336
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pablo LaPuerta
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Address
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Decibel Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04262336
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