New pill aims to stop chemo from stealing hearing
NCT ID NCT01451853
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to test whether an oral drug called SPI-1005 could prevent hearing loss and ringing in the ears caused by platinum-based chemotherapy. It was planned for adults with advanced lung or head and neck cancer. The study was withdrawn before enrolling any participants, so no results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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VA Puget Sound Health Care
Seattle, Washington, 98108, United States
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Other studies related to the condition(s) this trial covers.
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