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


Phase 2
19 Years
80 Years
Not Enrolling
Both
Lung Cancer, Head and Neck Cancer, Hearing Loss, Ototoxicity, Tinnitus, Neuropathy

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Trial Information

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


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

Type of Study:

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

Outcome Measure:

Number of participants with adverse events

Outcome Time Frame:

12 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

SPI-3005-201

NCT ID:

NCT01451853

Start Date:

March 2013

Completion Date:

June 2014

Related Keywords:

  • Lung Cancer
  • Head and Neck Cancer
  • Hearing Loss
  • Ototoxicity
  • Tinnitus
  • Neuropathy
  • Lung Cancer
  • Head and Neck Cancer
  • Hearing Loss
  • Ototoxicity
  • Tinnitus
  • Deafness
  • SPI-1005
  • Cisplatin
  • Carboplatin
  • Ebselen
  • Hearing Loss
  • Deafness
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Tinnitus

Name

Location

VA Puget Sound Health CareSeattle, Washington  98108