Clinical trial · Interventional
Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
NCT04812808CI-TRIAL-00056752BAZEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bazedoxifene 20 mg | Drug | Bazedoxifene | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bazedoxifene administered in addition to standard chemotherapy protocol
- interventionNames
- Drug: Bazedoxifene 20 mg
Primary outcomes (1)
- measure
- Change in IL-6/GP-130/STAT3 pathway expression (%)
- timeFrame
- 3 months
- description
- Assessment of IL-6 (GP130/STAT3) activity by immunohistochemistry on metastasis biopsy before and after treatment with bazedoxifene in addition to chemotherapy.
Secondary outcomes (18)
- measure
- Carbohydrate-Antigen 19-9 (CA 19-9) in U/ml
- timeFrame
- every 3 weeks for 3 months
- description
- The change in tumor marker CA 19-9 as a reflection of tumor progression. CA 19-9 will be measured on blood samples collected every 3 to 4 weeks throughout the trial and compared with the baseline prior to treatment initiation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.