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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003133-14 | EudraCT Number |
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This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.
LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients.
The primary objective of this study is to assess the tolerability of LUZ11 following single ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11 dose that has anti-tumor effect following photoactivation and to determine LUZ11 pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUZ11 PDT | Experimental | Study consists of two phases, in each participant:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUZ11 | Drug | LUZ11 i.v. administration followed by laser light irradiation |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session |
| Measure | Description | Time Frame |
|---|---|---|
| Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy | Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session |
| Measure | Description | Time Frame |
|---|---|---|
| LUZ11 Maximum Plasma Concentration (Cmax), Area Under the Concentration-Time Curve (AUC), Elimination Half-Life (T½), Volume of Distribution (Vd) and Clearance (CL) | Prior to dose, immediately after dose, and at 0.08, 0.5, 0.75, 1, 3, 6, 12, 24, 48 and 72 hours post-dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Almeida, MD, PhD | Luzitin SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital CUF Porto | Recruiting | Porto | 4100-180 | Portugal |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto) | Recruiting | Porto | 4200-072 | Portugal |
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