Clinical Trial: Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma

Brief Summary: The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy with WST11 in patients with non-resectable or inoperable biliary carcinoma.

Detailed Summary:

This is an open-label, prospective, multicentre, phase IIa study, evaluating a new therapeutic agent in the management of patients suffering from inoperable or non resectable biliary carcinoma. The patients will receive the dose of WST11 according to order of inclusion. The first 3 patients will receive 2.5 mg/kg. In the absence of toxicity, the following 9 patients will receive the dose of 5 mg/kg.

The patient is to receive anesthesia. WST11-mediated therapy will consist of the combination of single IV administration of WST11 at doses of 2.5mg/kg or 5mg/kg, using 753nm laser light at a fixed power of (150mW/cm) and light energy (200 J/cm) delivered through a diffusing fiber. The fiber is introduced in a transparent standard ERCP catheter and positioned under radioscopy in front of the lesion.


Sponsor: Steba Biotech S.A.

Current Primary Outcome: Evaluation of the safety based on analysis of adverse events , clinical laboratory tests, electrocardiogram, physical examination, absence of local or general complications and phototoxicity of WST11 in inoperable or non resectable cholangiocarcinoma [ Time Frame: Patient inclusion - Month 6 ]

Original Primary Outcome: Evaluation of the safety based on analysis of adverse events (clinical laboratory tests, electrocardiogram, physical examination, absence of local or general complications and phototoxicity) of WST11 in inoperable or non resectable cholangiocarcinoma [ Time Frame: Patient inclusion - Month 6 ]

Current Secondary Outcome:

  • Evaluation of the antitumor efficacy of WST11-mediated VTP therapy by comparing the objective response rate on the tumor. [ Time Frame: Month 1, Month 3 & Month 6 ]
  • Evaluation of the effect of WST11-mediated VTP therapy on cholestasis and on the incidence of biliary complications of obstructive origin. [ Time Frame: Month 1, Month 3 & Month 6 ]
  • Evaluation of the effect of treatment on patient quality of life QLQ-C30. [ Time Frame: Month 1, Month 3 & Month 6 ]
  • Evaluation of the global survival after WST11-mediated VTP [ Time Frame: Month 6 ]


Original Secondary Outcome:

  • Evaluation of the antitumor efficacy of WST11-mediated VTP therapy by comparing the objective response rate on the tumor. [ Time Frame: Month 1, Month 3 & Month 6 ]
  • Evaluation of the effect of WST11-mediated VTP therapy on cholestasis and on the incidence of biliary complications of obstructive origin. [ Time Frame: Month 1, Month 3 & Month 6 ]
  • Evaluation of the effect of treatment on patient quality of life QLQ-C30. [ Time Frame: Month 1, Month 3 & Month 6 ]


Information By: Steba Biotech S.A.

Dates:
Date Received: September 10, 2009
Date Started: September 2009
Date Completion:
Last Updated: April 14, 2016
Last Verified: April 2016