Study of Debio 1143 given with or without chemotherapy prior to head and neck cancer operation.

Phase 1

• Conditions: Squamous cell carcinoma of the head and neck; MedDRA version: 17.1Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004655-31-FR
• Lead Sponsor: Debiopharm International S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-09
• Study Completion: 2018-07-18
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Age 18 years and over.
2. Newly diagnosed histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
3. Patient selected for primary surgical treatment.
4. ECOG PS 0-1.
5. Neutrophil count > 1'500/mm3; platelet count > 75'000/mm3; WBC = 3.0/10-9L; bilirubin or creatinine < 2 times ULN, ALAT or ASAT < 5 times ULN.
6. Women of childbearing potential:
a. Negative serum pregnancy test at screening;
b. Agreement to use appropriate contraception methods from study entry to 6 months after the last treatment day. Agreement from male partner to use contraception methods.
7. Male patient agreement to use contraception methods from study entry to 6 months after the last treatment day.
8. Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Nasopharynx cancer, nasal cavity, and paranasal sinuses carcinomas, recurrent SCCHN.
2. Weight loss of more than 10% in the previous month.
3. Tumour of less than 2 cm in its largest diameter.
4. Distant metastases.
5. Active second malignancy during the last 5 years except non-melanomatous skin cancer or carcinoma in situ of the cervix.
6. Prior treatment with IAP inhibitors and TNF inhibitors.
7. Use or requirement for use of aspirin or aspirin-containing products with > 160 mg of aspirin per day.
8. Active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
9. Non-compensated liver cirrhosis (Child-Pugh class C).
10. Concomitant treatment with a drug on the prohibited medication list in Section 7.8.2.
11. Patients with known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
12. If female, pregnant or lactating.
13. Unable to swallow and retain oral medications.
14. Know contraindication to 18F-FDG PET.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified