MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients (MIT-001)
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| ClinicalTrials.gov Identifier: NCT04651634 |
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Recruitment Status :
Recruiting
First Posted : December 3, 2020
Last Update Posted : January 28, 2022
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Sponsor:
MitoImmune Therapeutics
Information provided by (Responsible Party):
MitoImmune Therapeutics
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Brief Summary:
The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Squamous Cell Carcinoma Oral Mucositis | Drug: MIT-001 plus CCRT | Phase 2 |
Oral mucositis associated with cancer therapy carries a significant morbidity. OM is a common complication in patients receiving CCRT used for treating HNSCC. Mucositis lesions can be painful, affect nutrition and quality of life (QoL), and have a significant economic impact. However, a definitive intervention regime has not been established. Therefore, it is essential to develop appropriate treatment.
MitoImmune Therapeutics Inc. (hereafter referred to as Sponsor) has developed MIT-001 which can scavenge abnormal levels of reactive oxygen species (ROS), enabling the cells to retain mitochondrial membrane permeability and mitochondrial function. This eventually inhibits additional ROS production, indicating that MIT-001 can prevent excessive inflammation caused by ROS. In addition, MIT-001 may possibly 1) block inflammatory cytokine production via inhibiting nuclear factor kappa B (NF kB) or inflammasome dependent pathways, 2) inhibit necrosis/necroptosis via blocking high mobility group box 1 (HMGB1) mediated cytokine production, and 3) balance regulation between T helper type 1/17 (Th1/17) and regulatory T cells.
Based on the pathophysiological progression of CCRT-associated OM, initiated by direct injury to basal epithelial cells which experience deoxyribonucleic acid (DNA) damage and increased ROS levels, Sponsor expects the prevention of OM in patients receiving CCRT of locally advanced HNSCC with MIT 001 by effectively scavenging increased ROS induced by CCRT.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The three active treatment groups will receive either 20, 40, and 60 mg/day of MIT-001 IV infusion for 30 minutes, two times per week for 5 to 7 continuous weeks until a cumulative radiation dose of between 60 and 72 Gy, with CCRT. Placebo group will receive placebo, manufactured with the same properties and appearance as MIT 001, at same treatment frequency as MIT-001 with CCRT. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | This study design will minimize bias and provide reference data (i.e., data from placebo treated subjects) which will aid in the interpretation of results. To limit the occurrence of conscious and unconscious bias in the conduct and interpretation of safety and efficacy results, the study is double blind where the subject, the Investigators/site staff, and the Sponsor staff remain unaware of the treatment assignment. The planned safety assessments that will be performed during the study are considered acceptable measures for ensuring the safety of subjects during a clinical study. |
| Primary Purpose: | Supportive Care |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of MIT-001 in Prevention of Oral Mucositis in Patients Receiving CCRT for Previously Untreated Locally Advanced HNSCC |
| Actual Study Start Date : | June 21, 2021 |
| Estimated Primary Completion Date : | September 30, 2022 |
| Estimated Study Completion Date : | September 30, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Head and neck squamous cell carcinoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: 20 mg
MIT-001 20 mg
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Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT |
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Experimental: 40 mg
MIT-001 40 mg
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Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT |
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Experimental: 60 mg
MIT-001 60 mg
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Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT |
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Placebo Comparator: Placebo
Matching placebo
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Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT |
Primary Outcome Measures :
- Incidence of severe OM [ Time Frame: From first treatment to 2 months of safety follow-up period after CCRT completion ]severe OM (WHO criteria Grade 3 or higher) at a cumulative radiation dose of 60 Gy
Secondary Outcome Measures :
- Incidence of OM [ Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion ]Incidence of OM of each Grade (WHO criteria)
- Time to onset of severe OM [ Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion ]Time to onset of severe OM, defined as Grade 3 or higher (WHO criteria)
- Mouth pain and discomfort [ Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion ]Patient-reported mucositis-related mouth pain and discomfort
- Analgesic use for OM [ Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion ]Frequency and Cumulative dose (in morphine mg equivalent)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed HNSCC (The American joint committee on cancer [AJCC] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx
- Treatment plan to receive a continuous course of intensity-modulated radiation therapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractions of 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60 to 72 Gy, α/β ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher.
- CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less
- Serum pregnancy test negative for women of childbearing potential (woman of childbearing potential [WOCBP]
Exclusion Criteria:
- Patients who have active mucositis at screening.
- Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study.
- Tumor of the lips, sinuses, or salivary glands or unknown primary tumors.
- Metastatic disease (M1) Stage.
- Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds.
- Any clinically significant and/or active infection, other systemic illness or condition (other than HNSCC) that would preclude them from participating in the study in the opinion of the Investigator.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04651634
Contacts
| Contact: Yunjeong Lee | +82 2 6933 6727 | yunjeong.lee@mitoimmune.com |
Locations
| United States, Arizona | |
| Banner MD Anderson Cancer Center | Not yet recruiting |
| Gilbert, Arizona, United States, 85234 | |
| Contact: Gary Walker, M.D. | |
| United States, California | |
| Norris Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Jacob Thomas, M.D. | |
| United States, Kansas | |
| Cancer Center of Kansas | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker Dakhil, M.D. | |
| United States, Missouri | |
| Washington University School of Medicine Siteman Cancer Center | Not yet recruiting |
| Saint Peters, Missouri, United States, 63110 | |
| Contact: Peter Oppelt, M.D. | |
| United States, New York | |
| James P. Wilmot Cancer Center | Not yet recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Michael Cummings, M.D. | |
| United States, North Carolina | |
| Wake Forest Baptist Health - Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Ryan Hughes, M.D. | |
| United States, Ohio | |
| James Cancer Hospital Solove Research Institute | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Sujith Baliga, M.D. | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center - Hillman Cancer Center | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 17109 | |
| Contact: David Clump, M.D. | |
| Korea, Republic of | |
| The Catholic University of Korea Saint Vincent's Hospital | Recruiting |
| Suwon, Gyeonggi-do, Korea, Republic of, 16247 | |
| Contact: Ho Jung An, M.D. | |
| Jeonbuk National University Hospital | Recruiting |
| Jeonju, Jeollabuk-do, Korea, Republic of, 54907 | |
| Contact: Eun-Kee Song, M.D. | |
| Keimyung University Dongsan Hospital | Not yet recruiting |
| Daegu, Korea, Republic of | |
| Contact: Keon Uk Park, M.D. | |
| National Cancer Center | Not yet recruiting |
| Goyang-si, Korea, Republic of | |
| Contact: Wonyoung Choi, M.D. | |
| Seoul National University Bundang Hospital | Not yet recruiting |
| Gyeonggi-do, Korea, Republic of, 13620 | |
| Contact: Keun-Wook Lee, M.D. | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 03082 | |
| Contact: Hong-Gyun Wu, M.D. | |
| Korea University Guro Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 08308 | |
| Contact: Eun-Joo Kang, M.D. | |
Sponsors and Collaborators
MitoImmune Therapeutics
Investigators
| Study Director: | Suyeong Kim, M.Pharm | MitoImmune Therapeutics |
| Responsible Party: | MitoImmune Therapeutics |
| ClinicalTrials.gov Identifier: | NCT04651634 |
| Other Study ID Numbers: |
MIT001-OM-01 |
| First Posted: | December 3, 2020 Key Record Dates |
| Last Update Posted: | January 28, 2022 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by MitoImmune Therapeutics:
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MIT-001 Oral Mucositis OM NecroX-7 |
CCRT-associated OM CCRT-induced OM Mitochondria-targeted ROS scavenger |
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck Mucositis Stomatitis Carcinoma, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases Head and Neck Neoplasms Neoplasms by Site |