Multiple Myeloma Clinical Trial
Official title:
Phase I Dose Finding Study Assessing Safety and Tolerability of SST0001 in Advanced Multiple Myeloma.
Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating, among other activities, cell invasion associated with cancer metastasis, angiogenesis, and inflammation. The heparanase enzyme is a promising target for development of new anticancer drugs. HS and the structurally related heparin are present in most animal species. As an analogue of the natural substrate of heparanase HS, heparin is considered to be a potent inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity and are strictly related to the anti-heparanase activity. In preclinical murine models SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models, with a significant reduction of subcutaneous growth of different multiple myeloma cell lines, when SST0001 was administered either alone or in combination with dexamethasone. The purpose of this study is to determine the safety and tolerability of escalating doses of SST0001 in the treatment of advanced refractory multiple myeloma.
Multicenter, open label, uncontrolled Phase I First In Man trial in advanced refractory
multiple myeloma, to determine the Maximum Tolerated Dose (MTD) of SST0001 given
subcutaneously (sc) once daily for 5 or 10 days, in a cycle of 28 days. A starting dose of 25
mg (flat dose) is given once daily for 5 days (from Day 1 to Day 5). In the subsequent cohort
25 mg are administered once daily for 10 days (from Day 1 to 5 and from Day 8 to 12). Dose
escalation with SST0001 administered for 10 days is performed in subsequent cohorts,
depending on toxicities observed.
Indirect pharmacokinetics based on Activated Partial Thromboplastin Time (aPTT) modifications
in all patients (minimum of 3 patients in each cohort) during the first cycle of treatment
and direct SST0001 concentrations measurements.
Pharmacodynamics in all patients during the first cycle of treatment, based on modifications
of coagulation parameters.
During the study any hints of anti-tumor activity will also be evaluated based on use of
surrogate parameters (monoclonal serum and urine protein modifications).
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