SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

Sound Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Hearing Loss; Tinnitus; Lung Cancer; Ototoxicity; Neuropathy; Head and Neck Cancer

Treatments: Drug: Placebo; Drug: SPI-1005 High Dose; Drug: SPI-1005 Middle Dose; Drug: SPI-1005 Low Dose

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01451853

SPI-3005-201

Details and patient eligibility

About

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 of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Full description

Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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
• Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
• IUD in place for at least 3 months prior to study;
• Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
• Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
• Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
• Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).

Exclusion criteria

• Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
• Presence of alcoholism or drug abuse
• Participation in another investigational drug or device clinical trial within 30 days prior to the study
• Female subjects who are pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

SPI-1005 Low Dose

Active Comparator group

Description:

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

Treatment:

Drug: SPI-1005 Low Dose

SPI-1005 Middle Dose

Active Comparator group

Description:

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

Treatment:

Drug: SPI-1005 Middle Dose

SPI-1005 High Dose

Active Comparator group

Description:

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

Treatment:

Drug: SPI-1005 High Dose

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo