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2022-02-01
2024-01-31
2024-05-31
10
NCT04812808
Hôpital Fribourgeois
Hôpital Fribourgeois
INTERVENTIONAL
Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-03-12 | N/A | 2022-02-09 |
2021-03-22 | N/A | 2022-02-25 |
2021-03-24 | N/A | 2022-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Bazedoxifene administered in addition to standard chemotherapy protocol | DRUG: Bazedoxifene 20 mg
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | every 3 weeks for 3 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Claudia Mellenthin, MD Phone Number: +41 26 306 22 60 Email: dr.mellenthin@hin.ch |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
