At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
Drug: GC4419 +2 moredrug
Likely dose
Cisplatin 100mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Multi-Center Study of the Effects of GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis Associated With Chemo RT for Locally Advanced, Non-Metastatic Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating Drug: GC4419, Intensity-modulated radiation therapy (IMRT), and 1 other intervention for Head and Neck Cancer and Oral Mucositis. Completed, enrolled 38 participants across 24 sites in 6 countries.
Detailed Summary
GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Oral Mucositis
CountriesBelgium, Czechia, Germany, Poland, Spain, Switzerland
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartJun 2020
First PostedAug 2020
Primary CompletionMar 2021
TodayJul 2026
First PostedAug 28, 2020
Enrollment StartJun 30, 2020
Primary CompletionMar 10, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.8 years ago
Interventions
Drug: GC4419drug
GC4419 60 Minute Infusion
Intensity-modulated radiation therapy (IMRT)radiation
2.0 to 2.2 Gy daily over 7 weeks
Cisplatindrug
100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses