Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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 IL-6 (GP130/STAT3)-pathway modification on metastasis biopsy of patients with metastatic pancreatic adenocarcinoma before and after treatment with bazedoxifene in addition to chemotherapy.

This study is a single-center, prospective, nonrandomized trial.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hôpital Fribourgeois; Vignot Lucie
• Treatments: Bazedoxifene

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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