Pancreas CancerBAZENCT04812808
Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
A study testing Bazedoxifene 20 mg in people with Pancreas Cancer, run by Hôpital Fribourgeois at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Bazedoxifene 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 31 May 2024
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
HFR Fribourg - cantonal hospital
Fribourg, 1708
Lucie Vignot, MD, +41 26 306 22 60, lucie.vignot@h-fr.ch
About this study
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.
Read the 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 adenocarcinoma who will undergo palliative treatment with standard first line chemotherapy (Gemcitabine +/- Nab-paclitaxel). Diagnosis must be confirmed by biopsy and metastasis must be accessible for percutaneous biopsy using imaging guidance. Further, only patients with an IL-6 (GP130/STAT3)-pathway activity of more than 5% on diagnostic biopsy will be included .
In addition to chemotherapy, patients will receive 20 mg bazedoxifene (Conbriza®) orally per day, subject to good clinical tolerance and in the absence of a biological contraindication.
Patients will receive bazedoxifene once a day at any time, with or without meals. Initiation of treatment will be simultaneous to the initiation of chemotherapy. Bazedoxifene (Conbriza®) will be prescribed and administered for the duration of the study. To minimize the risk of thrombo-embolic events, prophylactic rivaroxaban (Xarelto®) 10 mg orally once per day will be added for the duration of the bazedoxifene (Conbriza®) intake. Pantoprazole 20 mg once per day will be added in selected patients to minimize gastric complications according to the physician's appreciation. Participants will receive bazedoxifene (Conbriza®) and rivaroxaban (Xarelto®) for the entire study duration from a subinvestigator at treatment initiation visit.
Physical examination with vital parameters, laboratory testing (blood count, liver enzymes, creatinine) and tumor marker (CA 19-9) will be conducted in order to determine the baseline prior to the initiation of the treatment. The quality of life using the EORTC core quality of life questionnaire (QLQ-C30) will also be assessed at that point. Furthermore, the IL-6 pathway activity (GP130/STAT3) will be assessed immunohistochemically on metastasis biopsy before administration of bazedoxifene (Conbriza®). The tissue will be obtained by percutaneous biopsy using imaging guidance. A biopsy performed before study inclusion can be used as baseline to avoid a second biopsy.
Study enrollment and follow-up will be performed by the consultant physician at the HFR Fribourg in the department of oncology. The follow-up will be carried out every 3 to 4 weeks and will consist of a physical examination, vital parameters, laboratory testing (blood count, liver enzymes, creatinine, electrolytes) and tumor marker (CA 19-9). Plasma samples will be collected before and after treatment for storage and samples will be analyzed through next generation sequencing NGS. Quality-of-life will be assessed during the follow-ups and drug adherence will be monitored through patient survey.
After 3 months of treatment, the primary endpoint will be assessed. Thoraco-abdominal CT scan or PET-CT will be performed, and a biopsy of metastasis tissue will be repeated (percutaneous under radiological guidance) for immunohistochemical IL-6 pathway activity (GP130/STAT3) analysis. The activity of bazedoxifene (Conbriza®) on inflammatory pathways and tumor progression will be evaluated by comparing the modification in expression of the IL-6 pathway (GP130/STAT3) from baseline.
Patients will be instructed by the investigator to report the occurrence of any adverse event.
The expected duration of the study for each participant will be 12 to 16 weeks.
- Conditions
- Pancreas Cancer
- Being tested
- Bazedoxifene 20 mg
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bazedoxifene 20 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Bazedoxifene administered in addition to standard chemotherapy protocol | Experimental | Not described Receives: Drug: Bazedoxifene 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (18)
Carbohydrate-Antigen 19-9 (CA 19-9) in U/ml
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.
Measured: every 3 weeks for 3 months
Change in Quality of life measured by EORTC QLQ-C30
Quality of life using the quality-of-life questionnaire EORTC QLQ-C30. This variable will be measured every 3 to 4 weeks throughout the trial and compared with the baseline prior to treatment initiation. Score ranging from 0 to 100. High scale score represents a higher response level.
Measured: every 3 weeks for 3 months
Heart rate (bpm)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
Blood pressure (mmHg)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
Oxygen saturation (%)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
weight (kg)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
body temperature (°Celcius)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
liver enzymes (GOT/ASAT in U/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
liver enzymes (GPT/ALAT in U/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
liver enzymes (GGT in U/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
liver enzymes (alkaline phosphatase in U/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
liver enzymes (bilirubine in umol/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
renal parameters (creatinine in umol/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
electrolytes (sodium in mmol/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
electrolytes (potassium in mmol/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
electrolytes (phosphate in mmol/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
electrolytes (calcium in mmol/l)
Assess toxicity of bazedoxifene in combination with chemotherapy. Physical examination will be performed and blood samples, including renal and hepatic parameters, will be analyzed every 3 to 4 weeks.
Measured: every 3 weeks for 3 months
Number of patients with adverse events
Assess the number of patients with adverse events (according to CTCAE v5.0)
Measured: every 3 weeks for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Feb 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vignot Lucie, Hôpital Fribourgeois
- Investigators
- Lucie Vignot, MD, Principal investigator, Hôpital Fribourgeois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812808
- Sponsor's protocol ID
- Grant-2104
- Acronym
- BAZE
- Status last verified
- Feb 2022
- First submitted
- 12 Mar 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04812808
- Acronym / sponsor ID
- BAZE / Grant-2104
- Conditions
- Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 24 Mar 2021 (actual)
- 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.
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.
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 adenocarcinoma who will undergo palliative treatment with standard first line chemotherapy (Gemcitabine +/- Nab-paclitaxel). Diagnosis must be confirmed by biopsy and metastasis must be accessible for percutaneous biopsy using imaging guidance. Further, only patients with an IL-6 (GP130/STAT3)-pathway activity of more than 5% on diagnostic biopsy will be included .
In addition to chemotherapy, patients will receive 20 mg bazedoxifene (Conbriza®) orally per day, subject to good clinical tolerance and in the absence of a biological contraindication.
Patients will receive bazedoxifene once a day at any time, with or without meals. Initiation of treatment will be simultaneous to the initiation of chemotherapy. Bazedoxifene (Conbriza®) will be prescribed and administered for the duration of the study. To minimize the risk of thrombo-embolic events, prophylactic rivaroxaban (Xarelto®) 10 mg orally once per day will be added for the duration of the bazedoxifene (Conbriza®) intake. Pantoprazole 20 mg once per day will be added in selected patients to minimize gastric complications according to the physician's appreciation. Participants will receive bazedoxifene (Conbriza®) and rivaroxaban (Xarelto®) for the entire study duration from a subinvestigator at treatment initiation visit.
Physical examination with vital parameters, laboratory testing (blood count, liver enzymes, creatinine) and tumor marker (CA 19-9) will be conducted in order to determine the baseline prior to the initiation of the treatment. The quality of life using the EORTC core quality of life questionnaire (QLQ-C30) will also be assessed at that point. Furthermore, the IL-6 pathway activity (GP130/STAT3) will be assessed immunohistochemically on metastasis biopsy before administration of bazedoxifene (Conbriza®). The tissue will be obtained by percutaneous biopsy using imaging guidance. A biopsy performed before study inclusion can be used as baseline to avoid a second biopsy.
Study enrollment and follow-up will be performed by the consultant physician at the HFR Fribourg in the department of oncology. The follow-up will be carried out every 3 to 4 weeks and will consist of a physical examination, vital parameters, laboratory testing (blood count, liver enzymes, creatinine, electrolytes) and tumor marker (CA 19-9). Plasma samples will be collected before and after treatment for storage and samples will be analyzed through next generation sequencing NGS. Quality-of-life will be assessed during the follow-ups and drug adherence will be monitored through patient survey.
After 3 months of treatment, the primary endpoint will be assessed. Thoraco-abdominal CT scan or PET-CT will be performed, and a biopsy of metastasis tissue will be repeated (percutaneous under radiological guidance) for immunohistochemical IL-6 pathway activity (GP130/STAT3) analysis. The activity of bazedoxifene (Conbriza®) on inflammatory pathways and tumor progression will be evaluated by comparing the modification in expression of the IL-6 pathway (GP130/STAT3) from baseline.
Patients will be instructed by the investigator to report the occurrence of any adverse event.
The expected duration of the study for each participant will be 12 to 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bazedoxifene administered in addition to standard chemotherapy protocol | Experimental | Drug: Bazedoxifene 20 mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
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 |
|---|---|---|
| Bazedoxifene 20 mgBazedoxifene 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. | Drug | Bazedoxifene administered in addition to standard chemotherapy protocol |
Primary outcome
Change in IL-6/GP-130/STAT3 pathway expression (%)
Time frame: 3 months
Assessment of IL-6 (GP130/STAT3) activity by immunohistochemistry on metastasis biopsy before and after treatment with bazedoxifene in addition to chemotherapy.
18 secondary outcomes
Carbohydrate-Antigen 19-9 (CA 19-9) in U/ml
Time frame: every 3 weeks for 3 months
Change in Quality of life measured by EORTC QLQ-C30
Time frame: every 3 weeks for 3 months
Heart rate (bpm)
Time frame: every 3 weeks for 3 months
Blood pressure (mmHg)
Time frame: every 3 weeks for 3 months
Oxygen saturation (%)
Time frame: every 3 weeks for 3 months
weight (kg)
Time frame: every 3 weeks for 3 months
body temperature (°Celcius)
Time frame: every 3 weeks for 3 months
liver enzymes (GOT/ASAT in U/l)
Time frame: every 3 weeks for 3 months
liver enzymes (GPT/ALAT in U/l)
Time frame: every 3 weeks for 3 months
liver enzymes (GGT in U/l)
Time frame: every 3 weeks for 3 months
liver enzymes (alkaline phosphatase in U/l)
Time frame: every 3 weeks for 3 months
liver enzymes (bilirubine in umol/l)
Time frame: every 3 weeks for 3 months
renal parameters (creatinine in umol/l)
Time frame: every 3 weeks for 3 months
electrolytes (sodium in mmol/l)
Time frame: every 3 weeks for 3 months
electrolytes (potassium in mmol/l)
Time frame: every 3 weeks for 3 months
electrolytes (phosphate in mmol/l)
Time frame: every 3 weeks for 3 months
electrolytes (calcium in mmol/l)
Time frame: every 3 weeks for 3 months
Number of patients with adverse events
Time frame: every 3 weeks for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- 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.
Lucie Vignot, MD principal investigator
Hôpital Fribourgeois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bazedoxifene 20 mg in people with Pancreas Cancer, run by Hôpital Fribourgeois at 1 site in Switzerland.
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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Feb 2022. 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 Switzerland. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Mellenthin, MD (+41 26 306 22 60, dr.mellenthin@hin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IL-6/GP-130/STAT3 pathway expression (%) (time frame: 3 months). 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 25 Feb 2022.