Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13-50
SponsorUniversity Hospital Heidelberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Reference pathological proven diagnosis of DSRCT in any stage; or Reference pathological proven diagnosis of SySa, IRS III, metastatic or relapsed disease
High SSTR2/3/5 mRNA expression, as determined by RNA sequencing in the DKFZ/NCT/DKTK MASTER (ClinicalTrials.gov ID: NCT05852522) or INFORM programs.
Stable disease, partial or complete response after completion of standard treatment
Age from 13 to 50 years
Disqualifiers
History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
Concurrent or previous treatment within 30 days in another interventional clinical trial / Participation in other ongoing clinical trials.
Uncontrolled concurrent disease, in particular diabetes mellitus
Bleeding disorder
Trial design
Design model
Single group
Treatments tested in this trial
Signifor
DrugSignifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate). Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Pasireotid treatment single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
progression-free survival (PFS)
Assessment of clinical efficacy of pasireotide maintenance therapy
Time frame
PFS, measured from study registration to radiologically confirmed disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first up to 4 yearsSecondary outcomes
1
overall survival (OS)
Assessment of clinical efficacy of pasireotide maintenance therapy
Time frame
OS, measured from study registration to death from any cause (censoring of patients without an event at date of last follow-up) up to 4 yearsOther outcomes
1
measurable residual disease (MRD)
Assessment of MRD and identify resistance mechanisms in liquid biopsies before, during, and after pasireotide maintenance therapy
Time frame
MRD before, during, and after pasireotide maintenance therapy up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov