Inecalcitol-CT1
First clinical trial with inecalcitol administered orally. Up to 320 microgrammes of the inecalcitol were administered orally in a randomized double blind phase 1 trial against placebo on 54 healthy volunteers. No side-effects were observed. In particular, no hypocalcaemia or high level of calcium in the urine appeared, these disruptions of the calcic metabolism being the usual specific signs of the toxicity of the synthetic or natural derivatives of vitamin D. This observation is consistent with the low toxicity of the inecalcitol shown in preclinical trials, which were compared to calcitriol, the active natural metabolite of vitamin D3.
Inecalcitol-CT2
A phase 2 trial with the main purpose of determining the maximum tolerated dose of the inecalcitol in combination with the Taxotere® in patients suffering from a hormone resistant prostate cancer.
This trial began in November 2007 and was held in the medical oncology departments at the Georges Pompidou Hospital and the Institut Curie in Paris.
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The first patient has been treated in France on November 7, 2007 at the European Hospital Georges Pompidou in Paris. |
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