BridgeMD
SENS-401 to Prevent the Ototoxicity induced by Cisplatin in Adult Subjects with a Neoplastic Disease
EU CTIS ID: 2024-511713-38-00
What this study is testing
To evaluate the efficacy of SENS-401 given at the dose of 43.5 mg b.i.d. (bis in die) for up to 23 weeks to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease, 4 weeks after the completion of the last cisplatin treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years at the time of signing the ICF.
- Capable of giving signed informed consent as described in Appendix 2 of this protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- A female subject is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and ≥ 1 of the following conditions apply: • Not a woman of childbearing potential (WOCBP) as defined in Appendix 6. • A WOCBP who agrees to follow the contraceptive guidance in Appendix 6 for at least 30 days after the last dose of SENS-401 if cisplatin is not received or 6 months after the last dose of cisplatin.
- A male subject must agree to use contraception and refrain from donating sperm as detailed in Appendix 6 of this protocol for at least 30 days after the last dose of SENS-401 if cisplatin is not received or 6 months after the last dose of cisplatin.
- Neoplastic subject that, regardless of participation in this study, is planned to be treated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m2 per cycle and a cumulative dose of cisplatin of at least 210 mg/m2.
- 6b. Subjects with a PTA threshold of ≤ 30 dB at 500 Hz AND ≤ 40 dB at 1-2 kHz AND ≤ 60 dB at 4-6 kHz AND ≤ 80 dB at 8 kHz, in either both ears or one ear for a maximum of 30% of the subjects in each study arm.
You likely can't join if
- Any condition or past medical history that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
- History of meningitis.
- For a subject expected to receive radiotherapy during the course of the study, an anticipated risk of exposure of the auditory system (i.e. inner ear within the expected irradiation zone).
- History of significant arrhythmia or conditions known to increase proarrhythmic risk (e.g. congestive heart failure, long QT syndrome, hypokalemia).
- Significant clinically relevant electrocardiogram (ECG) abnormality that, in the opinion of the Investigator, precludes study eligibility.
- Significant abnormal laboratory result, physical examination, vital signs, or ear-nose-throat (ENT) evaluation (otoscopy and immittance audiometry), in the opinion of the Investigator.
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of signing the ICF.
- Capable of giving signed informed consent as described in Appendix 2 of this protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- A female subject is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and ≥ 1 of the following conditions apply: • Not a woman of childbearing potential (WOCBP) as defined in Appendix 6. • A WOCBP who agrees to follow the contraceptive guidance in Appendix 6 for at least 30 days after the last dose of SENS-401 if cisplatin is not received or 6 months after the last dose of cisplatin.
- A male subject must agree to use contraception and refrain from donating sperm as detailed in Appendix 6 of this protocol for at least 30 days after the last dose of SENS-401 if cisplatin is not received or 6 months after the last dose of cisplatin.
- Neoplastic subject that, regardless of participation in this study, is planned to be treated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m2 per cycle and a cumulative dose of cisplatin of at least 210 mg/m2.
- 6b. Subjects with a PTA threshold of ≤ 30 dB at 500 Hz AND ≤ 40 dB at 1-2 kHz AND ≤ 60 dB at 4-6 kHz AND ≤ 80 dB at 8 kHz, in either both ears or one ear for a maximum of 30% of the subjects in each study arm.
- In the opinion of the Investigator, a life expectancy of ≥ 6 months.
- Inclusion Criterion 8 about COVID-19 has been removed from study protocol v4.0.
What rules you out
- Any condition or past medical history that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
- History of meningitis.
- For a subject expected to receive radiotherapy during the course of the study, an anticipated risk of exposure of the auditory system (i.e. inner ear within the expected irradiation zone).
- History of significant arrhythmia or conditions known to increase proarrhythmic risk (e.g. congestive heart failure, long QT syndrome, hypokalemia).
- Significant clinically relevant electrocardiogram (ECG) abnormality that, in the opinion of the Investigator, precludes study eligibility.
- Significant abnormal laboratory result, physical examination, vital signs, or ear-nose-throat (ENT) evaluation (otoscopy and immittance audiometry), in the opinion of the Investigator.
- Neurological disorder including stroke, demyelinating disease, or brain stem or cerebellar dysfunction.
- Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 mL/min (calculated with the Cockcroft-Gault formula for subjects < 65 years old and with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation or with the Modification of Diet in Renal Disease (MDRD) equation for subjects ≥ 65 years old
- Exclusion Criterion 17 about statins has been removed from study protocol v4.0.
- Having received concomitant treatment known or suspected to induce an ototoxicity within 6 months prior to Screening (i.e. aminoglycosides, loop diuretics, quinine) and any other treatments listed in Appendix 5. Previous treatment with a platinum treatment should be considered as an exclusion criterion.
- Treatment with any investigational agent within 4 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer).
- Subject is the Investigator or anyone from his/her team directly involved in the conduct of the protocol.
- 20b. Known or suspected ongoing active infection of human immunodeficiency virus (HIV)
- 21. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction.
- Known hypersensitivity, allergy or intolerance to cisplatin or any history of severe abnormal drug reaction.
- Receiving phenytoin at screening (as it is contraindicated with cisplatin).
- Myelosuppressed at screening (as it is contraindicated with cisplatin).
- Any condition or health state at screening contraindicating the use of rehydration solution before each cisplatin cycle if requested (as dehydration state is contraindicated with cisplatin).
- Mentally unable to understand the nature, objectives, and possible consequences of the study or refusing its constraints.
- A congenital or hereditary disease known to decrease hearing function (e.g. Otoferlin [OTOF]-related deafness).
- Any medical history affecting the middle ear function such as chronic otitis, cholesteatoma, or tympanic membrane perforation.
- Any inner ear disease that is likely to decrease hearing function according to the Investigator’s judgment (e.g. herpes zoster oticus; Meniere’s disease; purulent labyrinthitis; vestibular schwannoma).
- Having a history of sudden sensory neural hearing loss.
- Having a fluctuating hearing loss (e.g. due to Meniere’s disease, vestibular aqueduct syndrome, or autoimmune inner ear disease).
- History of head trauma with hearing loss.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.