Status:
COMPLETED
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
Lead Sponsor:
Galera Therapeutics, Inc.
Conditions:
Head and Neck Cancer
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Subjects will receive 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximat...
Eligibility Criteria
Inclusion
- Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
- Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
- Patients who have had prior surgery may be eligible,
- Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).
- Age 18 years or older
- ECOG performance status ≤ 2
- Adequate hematologic function
- Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN
Exclusion
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
- Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
- Planned concurrent chemotherapy other than single agent cisplatin
- Receiving any approved or investigational anti-cancer agent
- Concurrent participation in another interventional clinical study
- Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
- Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
- Malignant tumors other than head and neck cancer (HNC) within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline.
- Known history of human immunodeficiency virus (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, in the judgment of the treating Investigator, create a risk for a precipitous decrease in blood pressure.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04529850
Start Date
June 30 2020
End Date
March 10 2021
Last Update
August 16 2022
Active Locations (24)
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1
Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
Aalst, Belgium
2
AZ Klina
Brasschaat, Belgium
3
Az Nikolaas
Sint-Niklaas, Belgium
4
CHR Verviers
Verviers, Belgium