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Home > "S" Clinical Trials Conditions > Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma  Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
For Condition: Liver Neoplasms
Status: Recruiting
Sponsor(s): LEO Pharma ,
Synopsis: The purpose of the study is to determine whether Seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma).
Details: -
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Expanded Access Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: Hospital in- or out patients, either sex, aged 18-75 years, with hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation. Patients must have measurable disease, and be classifiable as to BCLC stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67. Exclusion criteria: Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1, patients with another primary tumor, except basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years, a history of renal stone(s), a life expectancy < 3 months, WHO performance status 3 or 4, Okuda stage III. Patients with hypercalcemia, other clinically important laboratory abnormalities, previous/current calcium metabolic disease, taking calcium-lowering therapy or medication known to affect systemic calcium metabolism are also excluded. All patients must give their signed informed consent to join the study.
Total Enrollment: 700
Location and Contact Information:
Overall Study Official:
HanneHvidberg, Study Director, LEO Pharma
E.g. Heritage Medical Research Clinic (numerous facilities are recruiting in Canada) *Recruiting*
Calgary, Alberta, T2N4N1
Canada
Recruiting Kelly Burak 4032208457
E.g. St. Georges Hospital (numerous facilities are recruiting in UK) *Recruiting*
London, , SW17 0QT
United Kingdom
Recruiting Agnieszka Michael +44 181 725 2955
E.g. Hopital Beaujon, department of Hepato-gastro-enterologie 2 (numerous facilities are recruiting in France) *Recruiting*
Clichy, , F-92110 Clichy
France
Recruiting Francoise Degos +33 140 87 55 27
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain) *Recruiting*
Barcelona, , E-08036
Spain
Recruiting Jordi Bruix +34 93 227 5400
E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy) *Recruiting*
Milano, , I-20 122
Italy
Recruiting Massimo Colombo +39 2 55 03 54 32
Additional Information:
Study ID Numbers: EBC 9801 INT; EBC 9801 INT
Study Start Date: September 1999
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051532
Other Liver Neoplasms Studies:
1. A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) with Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver
2. Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
3. Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma.
4. Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
5. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
Related Studies:
Other Liver Neoplasms Clinical Trials
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Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
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