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Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02070432
Recruitment Status : Unknown
Verified March 2016 by Luzitin SA.
Recruitment status was:  Recruiting
First Posted : February 25, 2014
Last Update Posted : March 3, 2016
Information provided by (Responsible Party):
Luzitin SA

Brief Summary:
This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: LUZ11 Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Investigate the Tolerability, Pharmacokinetics and Anti-tumour Effect Following Photodynamic Therapy (PDT) With Single-ascending Doses of LUZ11 in Patients With Advanced Head and Neck Cancer
Study Start Date : February 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LUZ11 PDT

Study consists of two phases, in each participant:

  1. Dose-finding phase with sequential periods in which single-ascending doses of LUZ11 will be titrated up to a dose that shows to be effective following photoirradiation of small spots of tumor surface.
  2. Final PDT session with the previously identified individual effective dose.
Drug: LUZ11
LUZ11 i.v. administration followed by laser light irradiation

Primary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session ]

Secondary Outcome Measures :
  1. Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy [ Time Frame: Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session ]

Other Outcome Measures:
  1. LUZ11 Maximum Plasma Concentration (Cmax), Area Under the Concentration-Time Curve (AUC), Elimination Half-Life (T½), Volume of Distribution (Vd) and Clearance (CL) [ Time Frame: 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Men or non-pregnant, non-breast feeding women
  • Karnofsky performance status of 60% or greater
  • Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck
  • Clearly visible tumor on the oral cavity or cutaneous surface

Exclusion Criteria:

  • Known hypersensitivity to any of the formulation ingredients
  • Known hypersensitivity to porphyrins
  • Porphyria or other diseases exacerbated by light
  • Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site
  • Planned skin phototherapy session(s) within the study timeframe
  • Planned surgical procedure within the study timeframe
  • Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe
  • Existing therapy with a photosensitizing agent
  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening
  • Myocardial infarction within 6 months prior to screening
  • Contraindication to MRI with gadolinium
  • Unacceptable laboratory abnormalities
  • Clinically relevant 12-lead ECG abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02070432

Hospital CUF Porto Recruiting
Porto, Portugal, 4100-180
Contact: Lucio Lara-Santos, MD, PhD   
Principal Investigator: Lucio Lara Santos, MD, PhD         
Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto) Recruiting
Porto, Portugal, 4200-072
Contact: Lucio Lara-Santos, MD, PhD    +351225084000   
Sponsors and Collaborators
Luzitin SA
Study Director: Luis Almeida, MD, PhD Luzitin SA

Responsible Party: Luzitin SA Identifier: NCT02070432     History of Changes
Other Study ID Numbers: LUZ11-CDU-001
2013-003133-14 ( EudraCT Number )
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Luzitin SA:
head and neck cancer
photodynamic therapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site