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

Tracking Information
First Submitted Date ICMJE	September 10, 2009
First Posted Date ICMJE	September 11, 2009
Last Update Posted Date	April 18, 2016
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 14, 2016)	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; (submitted: September 10, 2009)	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; (submitted: March 2, 2011)	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; (submitted: September 10, 2009)	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: None (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
Actual Enrollment ICMJE; (submitted: April 14, 2016)	8
Original Estimated Enrollment ICMJE; (submitted: September 10, 2009)	12
Actual Study Completion Date	September 2012
Actual 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	No
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No
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