At a glance
ClinicalIndex Comparison Record- ✓Pathologically proven DSRCT in any stage OR SySa IRS III metastatic/relapsed disease
- ✓High SSTR2/3/5 mRNA expression by RNA sequencing
- ✓Stable disease, partial or complete response after standard treatment
- ✓Age 13 to 50 years
- ✕Hypersensitivity to investigational product or similar agents
- ✕Concurrent participation in other interventional trials within 30 days
- ✕Uncontrolled concurrent disease, particularly diabetes mellitus
- ✕Bleeding disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pasireotide as Maintenance Treatment With Monthly Deep Intramuscular Injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
In Brief
A Phase 2 clinical trial evaluating Signifor for Desmoplastic Small Round Cell Tumor and Synovial Sarcoma. Currently recruiting, targeting 28 participants across 4 sites.
Detailed Summary
PAMSARC is a non-commercial interventional Phase 2 clinical trial of academic research institutions, with its primary goal being to improve medical treatment of fusion driven Desmoplastic small round cell tumor (DSRCT) and Synovial sarcoma (SySa) in young adults and adolsecents with male predominance. Current management of DSRCT and SySa includes chemotherapy, radiation and aggressive cytoreductive surgery. Despite advances in multimodal therapy, outcomes remain poor with frequent disease recurrence and very limited options for patients with advanced disease. Selected somatostatin receptor (SSTR) family members, i.e., SSTR2, SSTR3 and SSTR5, are frequently overexpressed in DSRCT and SySa, providing the rationale for treatment with somatostatin analogues (SSA). Pasireotide is a SSA with high affinity for SSTR1, -2, -3, and -5 and is approved for the treatment of Cushing's disease and acromegaly and has also shown activity in other cancers. In patients with advanced stage DSRCT and SySa, conventional chemotherapeutic approaches frequently lead to disease response, however, the duration of progression-free time after chemotherapy is short. The targeted approach with pasireotide after initial intensive multimodal treatment may have the potential to significantly improve outcome.
Study Details
Timeline
Interventions
Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate). Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).