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R-Azasetron Besilate

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.

Table of Contents

What is R-Azasetron Besilate?

R-Azasetron Besilate, also known as SENS-401, is an investigational drug being developed by Sensorion[1]. It is currently being studied as a potential treatment to prevent hearing loss caused by cisplatin, a commonly used chemotherapy drug[1]. 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[1].

Medical Condition Targeted

The primary medical condition targeted by R-Azasetron Besilate is cisplatin-induced hearing loss[1]. 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[1].

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[1].

Clinical Trial Details

R-Azasetron Besilate is currently being studied in a Phase IIa clinical trial[1]. 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[1].

Dosage and Administration

In the clinical trial, R-Azasetron Besilate is being administered as follows[1]:

  • 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[1].

Potential Benefits

If successful, R-Azasetron Besilate could provide significant benefits to cancer patients receiving cisplatin chemotherapy[1]:

  • 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[1]:

  • 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[1].

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[1]:

  • 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[1].

Aspect Details
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)

FAQ

  • What is R-Azasetron Besilate (SENS-401) being studied for? R-Azasetron Besilate (SENS-401) is being studied to prevent hearing loss (ototoxicity) caused by cisplatin chemotherapy in adult cancer patients.
  • How is the drug administered in the clinical trial? In the trial, SENS-401 is given as an oral film-coated tablet at a dose of 43.5 mg twice daily for up to 23 weeks.
  • When do patients start taking SENS-401 in relation to their chemotherapy? Patients start taking SENS-401 one week before beginning cisplatin treatment, continue throughout their chemotherapy (up to 18 weeks), and for 4 weeks after stopping chemotherapy.
  • What type of cancer patients are eligible for this study? The study includes adult patients (18 years or older) with a neoplastic disease who are planned to receive cisplatin chemotherapy at a dose of at least 70 mg/m² per cycle and a total dose of at least 210 mg/m².
  • How is the effectiveness of SENS-401 measured in the trial? The main measure of effectiveness is the change in hearing threshold at three contiguous frequencies, assessed with a 0.5-12.5 kHz audiogram 4 weeks after completing the last cisplatin treatment.

Ongoing Clinical Trials on R-Azasetron Besilate

  • Study on SENS-401 to Prevent Hearing Loss Caused by Cisplatin in Adults with Cancer

    Not recruiting

    1 1
    Investigated drugs:
    France

Glossary

  • Ototoxicity: Damage to the ear (specifically to the cochlea or auditory nerve) caused by exposure to certain medications or chemicals, resulting in hearing loss.
  • Cisplatin: A chemotherapy drug used to treat various types of cancers, known to cause hearing loss as a side effect.
  • Neoplastic disease: A condition characterized by abnormal growth of cells, commonly known as cancer.
  • Audiogram: A graph that shows a person's ability to hear sounds at different pitches and volumes, used to evaluate hearing loss.
  • b.i.d.: Latin abbreviation for 'bis in die,' meaning twice a day.
  • Cumulative dose: The total amount of a drug given over a period of time.
  • Randomized controlled trial: A type of study where participants are randomly assigned to different treatment groups to compare outcomes.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being given.
  • Inclusion criteria: Specific characteristics that people must have to be able to participate in a clinical study.
  • Exclusion criteria: Specific characteristics that prevent people from participating in a clinical study.

References

  1. http://clinicaltrials.eu/trial/study-on-sens-401-to-prevent-hearing-loss-caused-by-cisplatin-in-adults-with-cancer/