In short
R-Azasetron Besilate, also known as SENS-401, is being studied in clinical trials to prevent hearing loss caused by cisplatin chemotherapy in adult cancer patients. This article discusses the ongoing research to evaluate the drug's effectiveness in protecting hearing during cancer treatment.
At a glance
- Drug Name
- R-Azasetron Besilate (SENS-401)
- Purpose
- Prevent hearing loss caused by cisplatin chemotherapy
- Study Type
- Phase IIa, multicenter, randomized, controlled, open-label
- Dosage
- 43.5 mg twice daily for up to 23 weeks
- Administration
- Oral film-coated tablet
- Target Population
- Adults with cancer receiving cisplatin chemotherapy
- Primary Outcome
- Change in hearing threshold 4 weeks after last cisplatin treatment
- Study Duration
- Up to 23 weeks (1 week before chemotherapy, up to 18 weeks during, 4 weeks after)
What is R-Azasetron Besilate?
R-Azasetron Besilate, also known as SENS-401, is an investigational drug being developed by Sensorion. It is currently being studied as a potential treatment to prevent hearing loss caused by cisplatin, a commonly used chemotherapy drug. R-Azasetron Besilate is considered a new chemical entity, which means it's a newly developed drug that hasn't been previously approved for medical use.
Medical Condition Targeted
The primary medical condition targeted by R-Azasetron Besilate is cisplatin-induced hearing loss. Cisplatin is a powerful chemotherapy drug used to treat various types of cancer. However, one of its significant side effects is damage to the inner ear, which can lead to permanent hearing loss. This condition is known as ototoxicity, which refers to the toxic effects of certain medications on the ear, particularly the cochlea or auditory nerve.
How It Works
While the exact mechanism of action is not detailed in the provided information, R-Azasetron Besilate is being investigated for its potential to prevent or reduce the ototoxic effects of cisplatin. The drug is designed to be taken before, during, and after cisplatin treatment to protect the hearing cells in the inner ear from damage.
Clinical Trial Details
R-Azasetron Besilate is currently being studied in a Phase IIa clinical trial. This is an important stage in drug development where researchers are testing the drug's effectiveness and safety in a larger group of patients. The trial is described as:
- Multicenter: Conducted at multiple research sites
- Randomized: Participants are randomly assigned to different treatment groups
- Controlled: Includes a control group for comparison
- Open-label: Both researchers and participants know which treatment is being given
The main objective of the trial is to evaluate how effective R-Azasetron Besilate is in preventing hearing loss caused by cisplatin in adults with cancer.
Dosage and Administration
In the clinical trial, R-Azasetron Besilate is being administered as follows:
- Form: Film-coated tablet
- Route: Oral use (taken by mouth)
- Dose: 43.5 mg twice daily (b.i.d.)
- Duration: Up to 23 weeks
- Schedule: Starting 1 week before cisplatin treatment, continuing throughout chemotherapy (up to 18 weeks), and for 4 weeks after stopping chemotherapy
The maximum daily dose is 87 mg, and the maximum total dose over the treatment period is 14,355 mg.
Potential Benefits
If successful, R-Azasetron Besilate could provide significant benefits to cancer patients receiving cisplatin chemotherapy:
- Prevention or reduction of hearing loss: This could help maintain patients' quality of life during and after cancer treatment
- Allowing for optimal cancer treatment: By reducing the risk of hearing loss, patients might be able to receive the full, most effective doses of cisplatin without compromising their hearing
Eligibility Criteria
The clinical trial has specific criteria for who can participate. Some key inclusion criteria are:
- Adults aged 18 or older
- Diagnosed with cancer requiring cisplatin treatment (at least 70 mg/m² per cycle and a cumulative dose of at least 210 mg/m²)
- Relatively normal hearing at the start of the study
- Life expectancy of at least 6 months
There are also several exclusion criteria, including certain medical conditions and treatments that could interfere with the study results or pose additional risks to participants.
Safety Considerations
As with any investigational drug, there may be unknown risks and side effects. The clinical trial is designed to monitor participants closely for any adverse effects. Some specific safety considerations mentioned in the trial information include:
- Participants with a history of certain heart conditions or significant ECG abnormalities are excluded
- People with moderate to severe kidney impairment are not eligible
- The trial excludes individuals with a history of certain ear diseases or conditions that could affect hearing
It's important to note that R-Azasetron Besilate is still in the testing phase, and its safety and effectiveness have not yet been fully established. Patients interested in this treatment should discuss it with their healthcare provider and consider participating in clinical trials if appropriate.