Status:
COMPLETED
A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
Lead Sponsor:
Galera Therapeutics, Inc.
Conditions:
Squamous Cell Carcinoma of the Oral Cavity
Squamous Cell Carcinoma of the Oropharynx
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standa...
Detailed Description
This is a multi-center, single-agent, open-label clinical trial to be conducted in serial cohorts of patients with squamous cell cancer of the head and neck receiving escalating doses of GC4419 in com...
Eligibility Criteria
Inclusion
- Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN), defined as SCC of the oral cavity or oropharynx, that will be treated with standard cisplatin and Intensity-Modulated Radiation Therapy (IMRT)
- Males or females aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate bone marrow, liver and kidney function
- Negative serum pregnancy test for females of childbearing potential
- Properly obtained written informed consent
Exclusion
- Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, salivary glands or unknown primary tumor
- Metastatic disease (Stage IV C)
- Prior chemotherapy for SCCHN and/or radiotherapy to the region of the study cancer or
- Receiving any agent classified as an antioxidant
- History of malignant tumors other than SCCHN within the last 5 years, except non-melanoma skin cancer or curatively excised in situ cervical carcinoma
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at study entry
- Chronic immunosuppression
- Known history of HIV or active hepatitis B/C )
- Prior history of hearing impairment
- Use of investigational agent within 30 days of study entry
- 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 :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01921426
Start Date
August 1 2013
End Date
August 1 2016
Last Update
September 22 2016
Active Locations (10)
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1
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198