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最高研发阶段临床1/2期 |
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A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma
The current phase I/IIa trial is a multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX. Each dose cohort will consist of 4 subjects. Each subject will receive up to 7 doses of ODX, given at 2-week intervals, until unacceptable toxicity or disease progression. A follow-up visit will be conducted 2 weeks after the last dose.
Primary objectives:
• To determine the safety and tolerability of ODX in subjects with relapsed/refractory multiple myeloma.
Secondary objectives:
* To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma.
* To evaluate the efficacy of ODX on serum biomarkers (M-protein, FLC, CTX, osteocalcin, and bone-specific S-ALP) in subjects with relapsed/refractory multiple myeloma.
Exploratory objective
• To evaluate time to progression by following M-protein and FLC levels as per clinical routine
A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma
A randomized, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases
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