Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma

NCT04812808 | Unknown DMC

• 1 other identifier: Grant-2104
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Change in IL-6/GP-130/STAT3 pathway expression (%)

  Assessment of IL-6 (GP130/STAT3) activity by immunohistochemistry on metastasis biopsy before and after treatment with bazedoxifene in addition to chemotherapy.

  3 months

Secondary Outcomes (18)

• Carbohydrate-Antigen 19-9 (CA 19-9) in U/ml

  every 3 weeks for 3 months

• Change in Quality of life measured by EORTC QLQ-C30

  every 3 weeks for 3 months

• Heart rate (bpm)

  every 3 weeks for 3 months

• Blood pressure (mmHg)

  every 3 weeks for 3 months

• Oxygen saturation (%)

  every 3 weeks for 3 months

Study Arms (1)

Bazedoxifene administered in addition to standard chemotherapy protocol

EXPERIMENTAL

Drug: Bazedoxifene 20 mg

Interventions

Bazedoxifene 20 mg DRUG

Bazedoxifene will be administered during the duration of the study in the experimental arm together with chemotherapy. Prophylactic rivaroxaban (Xarelto®) 10 mg per day orally will be added to avoid thromboembolic events.

Bazedoxifene administered in addition to standard chemotherapy protocol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Fribourgeois: lead

Study Sites (1)

HFR Fribourg - cantonal hospital

Fribourg, 1708, Switzerland

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Lucie Vignot, MD

  Hôpital Fribourgeois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Mellenthin, MD

CONTACT

+41 26 306 22 60; dr.mellenthin@hin.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, Department of Oncology, Principal Investigator

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 24, 2021
• Study Start: February 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: May 31, 2024
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)