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

NCT01451853 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: SPI-3005-201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Head and Neck Cancer; Hearing Loss; Ototoxicity; Tinnitus; Neuropathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  12 months

Secondary Outcomes (2)

• 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

Study Arms (4)

SPI-1005 Low Dose

ACTIVE COMPARATOR

200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Drug: SPI-1005 Low Dose

SPI-1005 Middle Dose

ACTIVE COMPARATOR

400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Drug: SPI-1005 Middle Dose

SPI-1005 High Dose

ACTIVE COMPARATOR

600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Drug: SPI-1005 High Dose

Placebo

PLACEBO COMPARATOR

0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Drug: Placebo

Interventions

SPI-1005 Low Dose DRUG

Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Arms: Low Dose Other Names: 200 mg Ebselen

Also known as: 200 mg Ebselen

SPI-1005 Low Dose

SPI-1005 Middle Dose DRUG

Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Also known as: 400 mg Ebselen

SPI-1005 Middle Dose

SPI-1005 High Dose DRUG

Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Also known as: 600 mg Ebselen

SPI-1005 High Dose

Placebo DRUG

Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Also known as: 0 mg Ebselen

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sound Pharmaceuticals, Incorporated: lead
• VA Puget Sound Health Care System: collaborator

Study Sites (1)

VA Puget Sound Health Care

Seattle, Washington, 98108, United States

Location

Related Publications (8)

• Rybak LP, Whitworth C, Somani S. Application of antioxidants and other agents to prevent cisplatin ototoxicity. Laryngoscope. 1999 Nov;109(11):1740-4. doi: 10.1097/00005537-199911000-00003.

  PMID: 10569399 BACKGROUND

• Rybak LP, Somani S. Ototoxicity. Amelioration by protective agents. Ann N Y Acad Sci. 1999 Nov 28;884:143-51.

  PMID: 10842591 BACKGROUND

• Lynch ED, Gu R, Pierce C, Kil J. Reduction of acute cisplatin ototoxicity and nephrotoxicity in rats by oral administration of allopurinol and ebselen. Hear Res. 2005 Mar;201(1-2):81-9. doi: 10.1016/j.heares.2004.08.002.

  PMID: 15721563 BACKGROUND

• Lynch ED, Gu R, Pierce C, Kil J. Combined oral delivery of ebselen and allopurinol reduces multiple cisplatin toxicities in rat breast and ovarian cancer models while enhancing anti-tumor activity. Anticancer Drugs. 2005 Jun;16(5):569-79. doi: 10.1097/00001813-200506000-00013.

  PMID: 15846123 BACKGROUND

• Knight KR, Kraemer DF, Winter C, Neuwelt EA. Early changes in auditory function as a result of platinum chemotherapy: use of extended high-frequency audiometry and evoked distortion product otoacoustic emissions. J Clin Oncol. 2007 Apr 1;25(10):1190-5. doi: 10.1200/JCO.2006.07.9723.

  PMID: 17401008 BACKGROUND

• Reavis KM, Phillips DS, Fausti SA, Gordon JS, Helt WJ, Wilmington D, Bratt GW, Konrad-Martin D. Factors affecting sensitivity of distortion-product otoacoustic emissions to ototoxic hearing loss. Ear Hear. 2008 Dec;29(6):875-93. doi: 10.1097/AUD.0b013e318181ad99.

  PMID: 18753950 BACKGROUND

• Kim SJ, Park C, Han AL, Youn MJ, Lee JH, Kim Y, Kim ES, Kim HJ, Kim JK, Lee HK, Chung SY, So H, Park R. Ebselen attenuates cisplatin-induced ROS generation through Nrf2 activation in auditory cells. Hear Res. 2009 May;251(1-2):70-82. doi: 10.1016/j.heares.2009.03.003. Epub 2009 Mar 13.

  PMID: 19286452 BACKGROUND

• Lynch E, Kil J. Development of Ebselen, a Glutathione Peroxidase Mimic, for the Prevention and Treatment of Noise-Induced Hearing Loss. Semin Hear 2009; 30(1): 047-055

  BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms; Hearing Loss; Ototoxicity; Tinnitus; Deafness

Interventions

ebselen

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Jonathan Kil, MD

  Sound Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Eric Lynch, PhD

CONTACT

(206) 634-2559; elynch@soundpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 14, 2011
• Study Start: January 15, 2018
• Primary Completion: June 26, 2019
• Study Completion: September 23, 2019
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)