Pasireotide for Synovial sarcoma | Desmoplastic small round cell tumor

Inclusion criteria

• {"criterion_text":"- Reference pathological proven diagnosis of DSRCT in any stage; or Reference pathological proven diagnosis of SySa, IRS III, metastatic or relapsed disease\n- High SSTR2/3/5 mRNA expression, as determined by RNA sequencing within DKFZ/NCT/DKTK MASTER program\n- Stable disease, partial or complete response after completion of standard treatment\n- Age from 13 to 50 years\n- Bodyweight ≥ 30 kg\n- Lansky-Index ≥ 80% in patients < 16 years of age and Karnofsky-Index ≥ 80% in patients ≥ 16 years of age (including adults).\n- No curative treatment option\n- Time from last chemotherapy (at least 2 chemotherapy cycles) to enrollment <8 weeks\n- For women of childbearing potential negative urine pregnancy test at screening as well as highly effective forms of contraception have to be in place thereafter\n- Female patients of childbearing potential and male patients with partners of childbearing potential who are sexually active must agree to the use of two forms of contraception in combination (male condom and one highly effective method). These should be started immediately after signing the informed consent form and continued throughout the period of study treatment plus 3 months for female and male patients. Male patients should refrain from fathering a child or donating sperm during the trial and for at least 3 months following the last dose.\n- Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment (for details refer to protocol)"}

Exclusion criteria

• {"criterion_text":"- 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\n- Concurrent or previous treatment within 30 days in another interventional clinical trial / Participation in other ongoing clinical trials\n- Uncontrolled concurrent disease, in particular diabetes mellitus\n- Bleeding disorder\n- Therapeutic anticoagulation which cannot be paused temporarily in order to ensure safe intramuscular injection\n- Is taking or requiring any of the prohibited medication listed in 6.4.2\n- Heart rate at rest < 60/min\n- fasting glucose level > 110mg/dl\n- Severe neurologic or psychiatric disorder\n- Pregnancy/lactation\n- Prior treatment with somatostatin analog"}

Primary endpoints

• {"endpoint_text":"- Progression free survival (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 (censoring of patients without an event at date of last follow-up)","definition_or_measurement_approach":"Measured from study registration to radiologically confirmed disease progression according to RECIST v1.1, or death from any cause; patients without an event are censored at date of last follow-up."}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS), measured from study registration to death from any cause (censoring of patients without an event at date of last follow-up)","definition_or_measurement_approach":"Measured from study registration to death from any cause; patients without an event are censored at date of last follow-up."}

Germany

Earliest CTIS Part Ii Submission Date

31-10-2024

Latest Decision Or Authorization Date

03-02-2025

Processing Time Days

95

Number Of Sites

4

Number Of Participants

28

Primary sponsor

Full Name

Universitaetsklinikum Heidelberg AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany