Advanced head and neck cancer. MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Redaporfin
Product Code: LUZ11
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Redaporfin
Other descriptive name: LUZ11
Concentration unit: mg/ml milligra
Sponsors
Luzitin, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of Redaporfin following single ascending doses of Redaporfin activated with a dose of 50 J/cm2 of laser light at 749±3 nm.;Secondary Objective: To explore the Redaporfin dose that has anti-tumour effect following activation with a dose of 50 J/cm2 of laser light at 749±3 nm. To measure the plasma concentrations of Redaporfin and its metabolites and to determine the corresponding pharmacokinetic parameters. ;Primary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics (PK): Cmax, AUC0-t, AUC0-8, AUC0- t/AUC0-8, Tmax, t½, ?z, Vd and CL Depth of tumour necrosis, as assessed by diffusion-weighted and perfusion MRI with gadolinium. ;Timepoint(s) of evaluation of this end point: PK: before infusion start; at infusion completion; and at 0.08 (5 minutes), 0.5 (30 minutes), 0.75 (45 minutes), 1, 3, 6, 12, 24, 48 and 72 h post-infusion completion. Depth of tumour necrosis: at admission, day 7, day 21 of each PDT treatment period and at the end of follow-up phase. | — |
Countries
Portugal
Contacts
Public ContactBlueclinical, Ltd.
Blueclinical - Investigacao e Desenvolvimento em Saude, Lda
Outcome results
None listed