Status:
UNKNOWN
Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
Hôpital Fribourgeois
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Bazedoxifene, a selective estrogen receptor modulator is thought to have effective anti-tumoral properties for pancreatic cancer via IL-6 pathway (GP130/STAT3) inhibition. The objective is to measure...
Detailed Description
This study is a single-center, prospective, non-randomized trial. The population studied will consist of 10 patients of both sexes, aged 18 to 85 years, with a newly diagnosed metastatic pancreatic ad...
Eligibility Criteria
Inclusion
- Adults aged from 18 to 85,
- Newly diagnosed metastatic pancreatic adenocarcinoma (stage IV according to AJCC)
- Accessible metastasis for percutaneous biopsy using imaging guidance
- IL-6 (GP130/STAT3)-pathway activity of more than 5% on diagnostic biopsy will be included
- Palliative chemotherapy planned,
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion
- No treatment for pancreatic adenocarcinoma,
- Curative treatment of pancreatic adenocarcinoma,
- No accessible metastasis for biopsy,
- Previous thrombo-embolic events,
- Known hypersensibility or allergy to bazedoxifene or one of the Conbriza excipient,
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Inability to give informed consent,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04812808
Start Date
February 1 2022
End Date
May 31 2024
Last Update
February 25 2022
Active Locations (1)
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1
HFR Fribourg - cantonal hospital
Fribourg, Switzerland, 1708