NCT02070432

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

2.4 years

First QC Date

February 20, 2014

Last Update Submit

March 1, 2016

Conditions

Head and Neck Cancer

Keywords

LUZ11head and neck cancerphotodynamic therapyRedaporfin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • 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

Study Arms (1)

LUZ11 PDT

EXPERIMENTAL

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

Interventions

LUZ11DRUG

LUZ11 i.v. administration followed by laser light irradiation

LUZ11 PDT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital CUF Porto

Porto, 4100-180, Portugal

RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)

Porto, 4200-072, Portugal

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Luis Almeida, MD, PhD

    Luzitin SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 25, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

PT(2)