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

This study is not yet open for participant recruitment.
Verified October 2012 by Sound Pharmaceuticals, Incorporated
Sponsor:
Collaborator:
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier:
NCT01451853
First received: October 7, 2011
Last updated: October 14, 2012
Last verified: October 2012
History of Changes
  Purpose

Chemotherapy treatment with the platinum containing chemotherapies (cisplatin, carboplatin) are well noted and studied for their ability to cause a side effect of hearing loss, also termed 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, during each cycle of cisplatin chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss.

SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic 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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sound Pharmaceuticals, Incorporated:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of hearing loss incidence and severity [ Time Frame: From baseline through 1 month after last chemotherapy cycle ] [ Designated as safety issue: No ]
  • Reduction of tinnitus incidence and severity. [ Time Frame: From baseline through 1 month after last chemotherapy cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose 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 Name: 200 mg Ebselen
Active Comparator: Middle Dose Drug: SPI-1005 Middle dose
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Name: 400 mg Ebselen
Active Comparator: High Dose Drug: SPI-1005 High Dose
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Name: 600mgEbselen
Placebo Comparator: Placebo Drug: Placebo
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Name: 0 mg Ebselen

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451853

Contacts
Contact: Tony S. Quang, M.D. (206) 768-5356 tquang@u.washington.edu

Locations
United States, Washington
VA Puget Sound Health Care Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Tony S. Quang, M.D.     206-768-5356     tquang@u.washington.edu    
Principal Investigator: Tony S Quang, M.D.            
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
VA Puget Sound Health Care System
  More Information

Publications:

Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT01451853     History of Changes
Other Study ID Numbers: SPI-3005-201
Study First Received: October 7, 2011
Last Updated: October 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sound Pharmaceuticals, Incorporated:
Lung Cancer
Head and Neck Cancer
Hearing Loss
Ototoxicity
Tinnitus
 Deafness
SPI-1005
Cisplatin
Carboplatin
Ebselen

Additional relevant MeSH terms:
Hearing Loss
Deafness
Head and Neck Neoplasms
Lung Neoplasms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Ebselen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on June 18, 2013