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

This study has been terminated.

(Early end of enrolment with regards to difficulty met to enrol patients .)

Sponsor:

Information provided by (Responsible Party):

Steba Biotech S.A.

ClinicalTrials.gov Identifier:

NCT00975039

First received: September 10, 2009

Last updated: April 14, 2016

Last verified: April 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2009

Last Updated Date

April 14, 2016

Start Date ^ICMJE

September 2009

Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00975039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cholangiocarcinoma

Intervention ^ICMJE

Drug: WST11

WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2.5 and 5 mg/kg, using 753nm laser light at a fixed power (150 mW/cm) and light energy (200 J/cm). Illumination in the bile duct is performed by inserting a diffusing fiber, with cylindrical uniform light distribution, in a transparent standard ERCP catheter and by positioning, under radioscopy, the illumination tip of the diffusing fiber in front of the lesion.

Other Name: WST11-mediated VTP

Study Arms

Experimental: WST11

Treatment with WST11-mediated VTP

Intervention: Drug: WST11

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

September 2012

Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient having signed the consent form to take part in the study
Patient aged over 18 years, with no upper age limit
Patient with histologically proven cholangiocarcinoma
Patient with cholangiocarcinoma, inoperable or non resectable owing to extension, age or concomitant diseases
Bilirubin level decrease of more than 50% after stent insertion compared to base level
Patient with a WHO Performance Scale ≤ 2
Patient in whom efficient drainage is performed by means of a plastic biliary stent endoscopically or radiologically
Patient capable of completing the quality of life questionnaires
Women of child-bearing potential must have a negative pregnancy test, and must thereafter prove to be using acceptable contraception (oral contraceptive pill, hormone patches, or IUD)

Exclusion Criteria:

Absence of consent to take part in the study
Patient with operable biliary carcinoma
Class ASA IV patients
Patients presenting clinical and laboratory signs of biliary infection
Absence of bilirubin decrease after stent insertion
Patients with extrinsic biliary compression
Patients already having received or currently receiving radiotherapy or chemotherapy for cholangiocarcinoma or needing to be treated during the first month of the follow-up
Known metastatic lesions
Patients having received immediate treatment by insertion of a metal stent
Patients with porphyria or known hypersensitivity to porphyrins (contraindication to WST11)
Patient receiving prohibited treatment at the time of inclusion in the study
Pregnant or breast-feeding women
Non-menopausal women not using effective contraception
Majors under protection as per the French Public Health Code
Persons not registered with or covered by a social security system
Persons in an exclusion period relative to other biomedical study

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00975039

Other Study ID Numbers ^ICMJE

CLIN904 CCM201

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

IPD Description

Not Provided

Responsible Party

Steba Biotech S.A.

Study Sponsor ^ICMJE

Steba Biotech S.A.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Emmanuel Ben Soussan, MD

Clinique de l'Alma

PRS Account

Steba Biotech S.A.

Verification Date

April 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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