An open-label study to investigate the tolerability, pharmacokinetics and anti-tumor effect following photodynamic therapy (PDT) with single-ascending doses of LUZ11 in patients with advanced head and neck cancer.

Phase 1

• Conditions: Advanced head and neck cancer.; MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003133-14-PT
• Lead Sponsor: uzitin, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-27
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Able and willing to give written informed consent and adhere to all requirements of the study.
2. Man or non-pregnant and non-breast feeding woman.
3. Age = 18 years.
4. Karnofsky performance status of 60% (60% = requiring some help, can take care of most personal requirements) or greater.
5. With histologically confirmed diagnosis of recurrent/refractory squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified (NOS), etc.) of the head/neck.
6. Clearly visible tumour on the oral cavity or cutaneous surface and that is locally accessible for surface irradiation using a microlens optic fibre.
7. Head and neck squamous cell carcinoma (HNSCC) progressing after first line of palliative chemotherapy OR progressing = 6 months after radical chemoradiotherapy OR considered not suitable for standard anti-neoplastic treatment by a multidisciplinary team.
8. Absolute granulocyte count >1,500 cells/mL.
9. Platelet count >100,000 cells/mL.
10. Haemoglobin >9.0 g/dL (the use of transfusion or other intervention to achieve Hgb >9.0 g/dL is acceptable).
11. Total bilirubin < 2 times the upper limit of normal (ULN).
12. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
13. Serum creatinine < 2 times the ULN or creatinine clearance (CrCL) >50 mL/min determined by 24-h urine collection or estimated by Cockroff-Gault formula: CrCL male = [(140-age) x (weight in kg] /[(serum Cr mg/dL) x (72)]; CrCL female = 0.85 x (CrCL male).
14. If woman, she is not of childbearing potential or she agrees to use a medically effective means of birth control.
15. If man, he is not sexually active or he agrees to use a medically effective means of birth control.
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 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Life expectancy less than 6 months.
2. Known hypersensitivity to porphyrins or any of the formulation ingredients.
3. History of severe hypersensitivity reactions to any drugs.
4. Porphyria or other diseases exacerbated by light.
5. Metastatic or locoregional progressive disease not amenable for complete treatment by PDT.
6. Tumours known to be eroding into a major blood vessel in or adjacent to the irradiation site.
7. Planned skin phototherapy session within the study timeframe.
8. Planned surgical procedure within the study timeframe.
9. Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe.
10. Existing therapy with a photosensitising agent.
11. Unacceptable laboratory abnormalities.
12. Clinically relevant 12-lead ECG abnormalities.
13. Unstable angina and/or congestive heart failure requiring hospitalisation within 6 months prior to screening.
14. Myocardial infarction within 6 months prior to screening.
15. Cannot communicate reliably with the investigator.
16. Unlikely to co-operate with the requirements of the study.
17. Contra-indication to MRI with gadolinium (e.g., use of pacemaker, allergy to gadolinium).
18. Participation in a clinical trial within 2 months prior to screening.
19. If woman, she has a positive pregnancy test.
20. If woman, she is currently breast-feeding.

Study & Design

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