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SST0001 (Roneparstat) in Advanced Multiple Myeloma

NCT01764880 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-10-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

SST0001 (Roneparstat)

SST0001 once daily for 5 or 10 days in a cycle of 28 days.

Sponsors & Collaborators

  • Sigma Tau Research Switzerland SA

    lead INDUSTRY

Principal Investigators

  • Alessandro Rambaldi, MD · USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy

  • Arnon Nagler, MD · Division of Hematology, Chaim Sheba Medical Center, Tel Hashomer, Israel

  • Manik Chatterjee, MD · Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik II (ZIM), Würzburg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Germany
  • Israel
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764880 on ClinicalTrials.gov