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

Sponsor

Sound Pharmaceuticals, Incorporated (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01451853

Collaborator

VA Puget Sound Health Care System (U.S. Fed)

Enrollment

Location

Arms

20.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Head and Neck Cancer Hearing Loss Ototoxicity Tinnitus Neuropathy	Drug: SPI-1005 Low Dose Drug: SPI-1005 Middle Dose Drug: SPI-1005 High Dose Drug: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss

Anticipated Study Start Date :

Jan 15, 2018

Anticipated Primary Completion Date :

Jun 26, 2019

Anticipated Study Completion Date :

Sep 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SPI-1005 Low Dose 200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy	Drug: SPI-1005 Low Dose Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Arms: Low Dose Other Names: 200 mg Ebselen Other Names: 200 mg Ebselen
Active Comparator: SPI-1005 Middle Dose 400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy	Drug: SPI-1005 Middle Dose Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Other Names: 400 mg Ebselen
Active Comparator: SPI-1005 High Dose 600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy	Drug: SPI-1005 High Dose Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Other Names: 600 mg Ebselen
Placebo Comparator: Placebo 0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy	Drug: Placebo Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Other Names: 0 mg Ebselen

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events [12 months]

Secondary Outcome Measures

Reduction of hearing loss incidence and severity [From baseline through 1 month after last chemotherapy cycle]
Reduction of tinnitus incidence and severity. [From baseline through 1 month after last chemotherapy cycle]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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