A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
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| ClinicalTrials.gov Identifier: NCT03689712 |
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Recruitment Status :
Recruiting
First Posted : September 28, 2018
Last Update Posted : October 8, 2018
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Sponsor:
Galera Therapeutics, Inc.
Information provided by (Responsible Party):
Galera Therapeutics, Inc.
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Brief Summary:
The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Oral Mucositis | Drug: GC4419 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 335 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer |
| Estimated Study Start Date : | October 2018 |
| Estimated Primary Completion Date : | October 2020 |
| Estimated Study Completion Date : | October 2024 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: GC4419 |
Drug: GC4419
60 minute IV infusion |
| Placebo Comparator: Placebo |
Drug: Placebo
60 minute IV infusion |
Primary Outcome Measures :
- Cumulative incidence of severe OM [ Time Frame: From the first IMRT fraction through the end of the study treatment period, which is estimated to be 7 weeks. ]
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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:
- squamous cell carcinoma of the head and neck
- treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
- Treatment plan to receive standard cisplatin monotherapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate hematologic, renal and liver function
- Negative serum pregnancy test
- Use of effective contraception
Exclusion Criteria:
- Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical
- Prior induction chemotherapy
- Receiving any approved or investigational anti-cancer agent other than those provided for in this study
- Concurrent participation in another interventional clinical study
- Inability to eat soft solid food at baseline
- Malignant tumors other than HNC within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline
- Known history of HIV or active hepatitis B/C
- Female patients who are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
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): NCT03689712
Contacts
| Contact: Jeffrey M Brill | (610) 725-1500 | info@galeratx.com |
Locations
| United States, Washington | |
| Cancer Care NW | Recruiting |
| Spokane, Washington, United States, 99216 | |
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
| Study Chair: | Jon T. Holmlund, MD | Cheif Medical Officer |
| Responsible Party: | Galera Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03689712 History of Changes |
| Other Study ID Numbers: |
GTI-4419-301 |
| First Posted: | September 28, 2018 Key Record Dates |
| Last Update Posted: | October 8, 2018 |
| Last Verified: | October 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Galera Therapeutics, Inc.:
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Oral Mucositis Superoxide Dismutase Mimetic Cisplatin Intensity-Modulated Radiation Therapy Chemoradiation OM IMRT |
Head and Neck Cancer Squamous Cell Carcinoma SCC Oral Cavity Oropharnyx Mouth Sores |
Additional relevant MeSH terms:
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Head and Neck Neoplasms Mucositis Stomatitis Neoplasms by Site Neoplasms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Mouth Diseases Stomatognathic Diseases Superoxide Dismutase Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |