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

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ClinicalTrials.gov Identifier: NCT01451853
Recruitment Status : Not yet recruiting
First Posted : October 14, 2011
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Tracking Information
First Submitted Date  ICMJE October 7, 2011
First Posted Date  ICMJE October 14, 2011
Last Update Posted Date September 25, 2017
Estimated Study Start Date  ICMJE January 15, 2018
Estimated Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2011)
Number of participants with adverse events [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01451853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2011)
  • Reduction of hearing loss incidence and severity [ Time Frame: From baseline through 1 month after last chemotherapy cycle ]
  • Reduction of tinnitus incidence and severity. [ Time Frame: From baseline through 1 month after last chemotherapy cycle ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
Official Title  ICMJE Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Head and Neck Cancer
  • Hearing Loss
  • Ototoxicity
  • Tinnitus
  • Neuropathy
Intervention  ICMJE
  • 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
  • Drug: SPI-1005 Middle Dose
    Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
    Other Name: 400 mg Ebselen
  • Drug: SPI-1005 High Dose
    Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
    Other Name: 600 mg Ebselen
  • Drug: Placebo
    Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
    Other Name: 0 mg Ebselen
Study Arms  ICMJE
  • Active Comparator: SPI-1005 Low Dose
    200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
    Intervention: Drug: SPI-1005 Low Dose
  • Active Comparator: SPI-1005 Middle Dose
    400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
    Intervention: Drug: SPI-1005 Middle Dose
  • Active Comparator: SPI-1005 High Dose
    600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
    Intervention: Drug: SPI-1005 High Dose
  • Placebo Comparator: Placebo
    0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2011)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 23, 2019
Estimated Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Lynch, PhD (206) 634-2559 elynch@soundpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01451853
Other Study ID Numbers  ICMJE SPI-3005-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sound Pharmaceuticals, Incorporated
Study Sponsor  ICMJE Sound Pharmaceuticals, Incorporated
Collaborators  ICMJE VA Puget Sound Health Care System
Investigators  ICMJE
Study Director: Jonathan Kil, MD Sound Pharmaceuticals, Inc.
PRS Account Sound Pharmaceuticals, Incorporated
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP