Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplati⦠(NCT04262336) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment
United States, Australia22 participantsStarted 2020-02-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 ā„ 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 integrā¦
What they're measuring
1
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
Timeframe: 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