EUCTR2016-000373-21-IT
Active, not recruiting
Phase 1
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy with theIRX-2 Regimen in Patients with Newly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity - NA
Conditionsewly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of theOral Cavity.MedDRA version: 20.0Level: PTClassification code 10041857Term: Squamous cell carcinoma of the oral cavitySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ewly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of theOral Cavity.
- Sponsor
- IRX THERAPEUTICS, INC.
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pathologically confirmed diagnosis of Stage II, III or IVA squamous cell cancer of the oral cavity (excluding the lip).
- •2\. Subjects: males or females at least 18 years of age at study entry.
- •3\. Disease is surgically resectable with a curative intent.
- •4\. Karnofsky Performance Status \= 70%.
- •5\. Haematological, Hepatic and Renal functions are adequate for surgical intervention.
- •6\. Females of child\-bearing potential must have negative urine/serum pregnancy test and agree to used a highly effective form of birth control.
- •7\. Subjects are able to give Informed Consent and adhere to the protocol treatment plan.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Prior surgery, radiation or chemotherapy (excluding biopsy or any procedure required for supportive care).
- •2\. Tumour of the oropharynx.
- •3\. Tumour involvement likely to be associated with T4b cancer.
- •4\. Distant metastased (M1 disease).
- •5\. Diagnosis of another invasive cancer which is currently not in remission and has required treatment within the last 5 years.
- •6\. Known infection with hepatitis B, C or HIV.
- •7\. Use of any Investigational agent within 30 days of randomization.
- •8\. Symptomatic cardiopulmonary disease which are not clinical stable.
- •9\. Myocardial infarction within the last 3 months.
- •10\. Stroke or other cerebral vascular insufficiency within last 3 months.
Outcomes
Primary Outcomes
Not specified
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