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- sodium thiosulfate (DB-020) / Regeneron
A phase 1 clinical trial of DB-020 intratympanic injections administered prior to high-dose cisplatin chemotherapy to reduce ototoxicity. (Hall A; Poster Bd #: 416) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3550;
P1b
In this initial clinical trial experience, there was no significant safety signal, and DB-020 IT injections showed a meaningful reduction in CP-induced ototoxicity.
- || sodium thiosulfate (DB-020) / Regeneron
Trial completion: Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - Jul 6, 2023
P1b, N=22, Completed, Sponsor: Decibel Therapeutics
In this initial clinical trial experience, there was no significant safety signal, and DB-020 IT injections showed a meaningful reduction in CP-induced ototoxicity. Active, not recruiting --> Completed
- sodium thiosulfate (DB-020) / Decibel Therap
A phase 1 clinical trial of DB-020 intratympanic injections administered prior to high dose cisplatin chemotherapy to reduce ototoxicity. (On Demand | Hall A; Poster Bd # 35) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3819;
P1b
These results warrant further clinical development. Clinical trial information: NCT04262336.
- || sodium thiosulfate (DB-020) / Regeneron
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - Jul 29, 2022
P1b, N=22, Active, not recruiting, Sponsor: Decibel Therapeutics
Clinical trial information: NCT04262336. Recruiting --> Active, not recruiting | N=70 --> 22 | Trial completion date: Dec 2023 --> Jul 2023 | Trial primary completion date: Dec 2022 --> Jul 2022
- || sodium thiosulfate (DB-020) / Regeneron
Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - Mar 23, 2022
P1b, N=70, Recruiting, Sponsor: Decibel Therapeutics
Recruiting --> Active, not recruiting | N=70 --> 22 | Trial completion date: Dec 2023 --> Jul 2023 | Trial primary completion date: Dec 2022 --> Jul 2022 Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Sep 2021 --> Dec 2022
- || cisplatin / Generic mfg.
Clinical, P1 data, PK/PD data, Journal: Phase 1 study to evaluate safety, tolerability and pharmacokinetics of a novel intra-tympanic administered thiosulfate to prevent cisplatin-induced hearing loss in cancer patients. (Pubmed Central) - Sep 4, 2021
Furthermore, DB-020 was safe and well tolerated with most adverse events reported as transient, of mild-to-moderate severity and related to the IT administration procedure. These results support the design and execution of the ongoing proof-of-concept study, DB-020-002, to assess otoprotection using DB-020 in cancer patients receiving cisplatin without negatively impacting cisplatin anti-tumor efficacy.
- || sodium thiosulfate (DB-020) / Regeneron
Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - Jul 21, 2020
P1b, N=70, Recruiting, Sponsor: Decibel Therapeutics
These results support the design and execution of the ongoing proof-of-concept study, DB-020-002, to assess otoprotection using DB-020 in cancer patients receiving cisplatin without negatively impacting cisplatin anti-tumor efficacy. Trial completion date: Oct 2021 --> Mar 2022 | Trial primary completion date: Apr 2021 --> Sep 2021
- || sodium thiosulfate (DB-020) / Decibel Therap
We may be sheltering in place but are still #fightingacure @AmericanCancer @ILDiscoveryBall #WhereIRise #db2020 (Twitter) - May 21, 2020
- | sodium thiosulfate (DB-020) / Regeneron
New P1 trial: Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - Feb 9, 2020
P1b, N=70, Recruiting, Sponsor: Decibel Therapeutics