CholangiocarcinomaPhase 2NCT00975039
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
A Phase 2 study testing WST11 in people with Cholangiocarcinoma, run by Steba Biotech S.A. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- WST11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma
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.
Read the 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- WST11
- Keywords
- Inoperable, Inoperable Cholangiocarcinoma, Non-resectable, Non-resectable Cholangiocarcinoma, Carcinoma
- Medical subject headings
- Cholangiocarcinoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WST11Drug
Also called WST11-mediated VTP
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.
| Study group | Role | What they receive |
|---|---|---|
| WST11 | Experimental | Treatment with WST11-mediated VTP Receives: Drug: WST11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Patient inclusion - Month 6
Secondary outcomes (4)
Evaluation of the antitumor efficacy of WST11-mediated VTP therapy by comparing the objective response rate on the tumor.
Measured: 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.
Measured: Month 1, Month 3 & Month 6
Evaluation of the effect of treatment on patient quality of life QLQ-C30.
Measured: Month 1, Month 3 & Month 6
Evaluation of the global survival after WST11-mediated VTP
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionSep 2012
Why it stopped: Early end of enrolment with regards to difficulty met to enrol patients .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Ben Soussan, MD, Principal investigator, Clinique de l'Alma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975039
- Sponsor's protocol ID
- CLIN904 CCM201
- Status last verified
- Apr 2016
- First submitted
- 10 Sep 2009
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT00975039
- Acronym / sponsor ID
- CLIN904 CCM201
- Conditions
- Cholangiocarcinoma
- Keywords
- Inoperable, Inoperable Cholangiocarcinoma, Non-resectable, Non-resectable Cholangiocarcinoma, Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early end of enrolment with regards to difficulty met to enrol patients .
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WST11 | Experimental | Drug: WST11Treatment with WST11-mediated VTP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WST11Also: WST11-mediated VTPWST11-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. | Drug | WST11 |
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
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Early end of enrolment with regards to difficulty met to enrol patients .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Ben Soussan, MD principal investigator
Clinique de l'Alma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WST11 in people with Cholangiocarcinoma, run by Steba Biotech S.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Early end of enrolment with regards to difficulty met to enrol patients .). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.