SPI-1005 for Chemotherapy-Induced Hearing Loss

Overseen By Eric Lynch, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sound Pharmaceuticals, Incorporated

Must not be taking: Chemotherapy, Antibiotics, Diuretics

Disqualifiers: Cardiovascular, Pulmonary, Renal, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies with chemotherapy cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SPI-1005, an experimental drug, to determine its effectiveness in preventing and treating hearing loss and tinnitus caused by certain chemotherapy drugs. The study will assess the safety and efficacy of SPI-1005 by testing three different doses alongside a placebo, which contains no active drug. People with advanced head and neck or lung cancer undergoing chemotherapy may be suitable candidates, especially if concerned about hearing issues from their treatment. Participants will take SPI-1005 or a placebo twice daily for three days around each chemotherapy session. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you've been treated with certain chemotherapy, antibiotics, or diuretics that cause hearing loss in the last 90 days, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SPI-1005 is generally safe for humans. Different studies found no serious side effects directly linked to the treatment. Most reported side effects were mild to moderate. For example, studies involving patients with Meniere's disease and other conditions reported side effects similar in type and severity, regardless of the dose. This suggests that SPI-1005 might be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for preventing chemotherapy-induced hearing loss?

Unlike the standard treatments for chemotherapy-induced hearing loss, like corticosteroids or antioxidants, SPI-1005 offers a unique approach by using ebselen, a synthetic compound that mimics the action of an enzyme called glutathione peroxidase. This enzyme plays a crucial role in protecting cells from damage caused by oxidative stress, which is a key factor in hearing loss during chemotherapy. Researchers are excited about SPI-1005 because it not only targets this oxidative stress more directly but also has a convenient oral capsule form, making it easier for patients to take. Plus, the study is exploring different dosages, which might help tailor the optimal treatment for different patients.

What evidence suggests that SPI-1005 could be effective for preventing chemotherapy-induced hearing loss and tinnitus?

Research has shown that SPI-1005 can reduce hearing loss caused by certain treatments. Studies have found it protects hearing in patients taking cisplatin, a common chemotherapy drug that often leads to hearing problems. SPI-1005 has also shown promise in treating hearing loss from other causes, such as loud noise. Other trials have found it safe and effective for conditions like Meniere's disease, which also affects hearing. This trial will evaluate different dosages of SPI-1005—high, middle, and low—to determine its effectiveness in reducing chemotherapy-induced hearing loss. These findings suggest that SPI-1005 could benefit those at risk of hearing loss from chemotherapy. ^{3 6 7 8 9}

Who Is on the Research Team?

Jonathan Kil, MD

Principal Investigator

Sound Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Adult male and female subjects, 19-80 years of age;

Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer

Voluntarily consent to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SPI-1005 or placebo orally twice daily for 3 days surrounding each cycle of platinum chemotherapy

Varies with chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPI-1005

How Is the Trial Designed?

Group I: SPI-1005 High Dose Active Control 1 Intervention

600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Group II: SPI-1005 Middle Dose Active Control 1 Intervention

400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Group III: SPI-1005 Low Dose Active Control 1 Intervention

200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Group IV: Placebo Placebo Group 1 Intervention

0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Who Is Running the Clinical Trial?

Sound Pharmaceuticals, Incorporated

Lead Sponsor

Trials

14

Recruited

1,300+

VA Puget Sound Health Care System

Collaborator

Trials

67

Recruited

225,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01451853

SPI-1005 for Prevention and Treatment of Chemotherapy ...

SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies. Official Title. Safety and Efficacy Study of SPI-1005 for ...

2.

soundpharma.com

soundpharma.com/sound-pharma-announces-positive-phase-3-results-for-the-treatment-of-menieres-disease-with-spi-1005/

Sound Pharma Announces Positive Phase 3 Results for ...

SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss and two types of ototoxicity (hearing loss ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5488860/

Early investigational drugs for hearing loss - PMC

The objective of this trial is to evaluate the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0378595521000435

Development of ebselen for the treatment of sensorineural ...

Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's disease and acute noise-induced hearing loss. SPI- ...

5.

trial.medpath.com

trial.medpath.com/clinical-trial/f0c32ddff3471639/nct01451853-safety-efficacy-study-spi-1005-prevention-chemotherapy-hearing-loss

SPI-1005 for Prevention and Treatment of Chemotherapy ...

Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03325790

SPI-1005 for the Treatment of Patients With Meniere's ...

This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in ...

7.

soundpharma.com

soundpharma.com/university-of-oxford-and-sound-pharmaceuticals-complete-phase-2-bipolar-disorder-study-with-spi-1005/

University of Oxford and Sound Pharmaceuticals complete ...

SPI-1005 was very well tolerated with only mild to moderate adverse events that were similar in incidence and severity to those observed in ...

8.

soundpharma.com

soundpharma.com/wp-content/uploads/2018/11/2018-ARO-151.pdf

SPI-1005 A Novel Investigational Drug For The Treatment ...

Safety Analysis. There have been no reported Serious Adverse Events or AEs that were definitely or probably due to study drug. All AEs were mild to moderate ...

9.

pharmacytimes.com

pharmacytimes.com/view/phase-3-data-offer-hope-to-patients-with-meniere-disease

Phase 3 Data Offer Hope to Patients With Meniere Disease

SPI-1005 demonstrated significant efficacy in improving hearing loss and speech discrimination in Meniere disease patients during a phase 3 ...