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| ID | Type | Description | Link |
|---|---|---|---|
| EBC 9801 INT |
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The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seocalcitol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, defined as the time from start of treatment to death |
| Measure | Description | Time Frame |
|---|---|---|
| HCC-specific survival from start of treatment | ||
| Time to response from start of treatment (complete or partial response) | ||
| Proportion of patients who achieve partial/complete response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne Hvidberg, MSc Pharm, PhD | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada) | Toronto | Alberta | M5G2C4 | Canada |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C078903 | seocalcitol |
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| Time to progression measured from start of treatment |
| Duration of complete response in patients showing a complete response, measured from the first date when absence of disease was recorded until the first date of disease progression was recorded |
| Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed |
| Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed |
| Change(s) in tumour size |
| Change in tumour marker |
| Number of days of hospitalisation (in-patient care) |
| Quality of life |
| Adverse events |
| Change in laboratory values |
| Dose of seocalcitol (seocalcitol treated patients) |
| E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France) | Metz | F-57038 Metz Cedex | France |
| E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy) | Milan | I-20 122 | Italy |
| E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain) | Barcelona | E-08036 | Spain |
| E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK) | Edinburgh | EH39YW | United Kingdom |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |