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RECRUITING
NCT06456359
PHASE2

Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor

Sponsor: University Hospital Heidelberg

View on ClinicalTrials.gov

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.

Official title: Pasireotide as Maintenance Treatment With Monthly Deep Intramuscular Injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor

Key Details

Gender

All

Age Range

13 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2024-12-19

Completion Date

2028-10

Last Updated

2025-01-13

Healthy Volunteers

No

Interventions

DRUG

Signifor

Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate). Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).

Locations (4)

National Center for Tumour Diseases, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Klinikum Stuttgart- Olga Hospital Zentrum für Kinder-, Jugend und Frauenmedizin

Stuttgart, Baden-Wurttemberg, Germany

Klinikum Stuttgart Studienzentrale Stuttgart Cancer Center, Tumorzentrum Eva-Mayr-Stihl

Stuttgart, Baden-Wurttemberg, Germany

Universitätsklinikum Essen Pädiatrische Hämatologie und Onkologie

Essen, North Rhine-Westphalia, Germany