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Pasireotide as Maintenance Treatment with monthly deep intramuscular injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor (PAMSARC)
EU CTIS ID: 2024-511935-86-00
What this study is testing
To assess the clinical efficacy of pasireotide maintenance therapy for prolonging progression-free survival (PFS) in patients with SSTR2/3/5-expressing synovial sarcoma (SySa) and desmoplastic small round cell tumor (DSRCT)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Reference pathological proven diagnosis of DSRCT in any stage; or Reference pathological proven diagnosis of SySa, IRS III, metastatic or relapsed disease
- 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.
- Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment (for details refer to protocol)
- High SSTR2/3/5 mRNA expression, as determined by RNA sequencing within DKFZ/NCT/DKTK MASTER program
- Stable disease, partial or complete response after completion of standard treatment
- Age from 13 to 50 years
You likely can't join if
- 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
- Pregnancy/lactation
- Prior treatment with somatostatin analog
- 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
See the full eligibility criteria
- Reference pathological proven diagnosis of DSRCT in any stage; or Reference pathological proven diagnosis of SySa, IRS III, metastatic or relapsed disease
- 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.
- Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment (for details refer to protocol)
- High SSTR2/3/5 mRNA expression, as determined by RNA sequencing within DKFZ/NCT/DKTK MASTER program
- Stable disease, partial or complete response after completion of standard treatment
- Age from 13 to 50 years
- Bodyweight ≥ 30 kg
- Lansky-Index ≥ 80% in patients < 16 years of age and Karnofsky-Index ≥ 80% in patients ≥ 16 years of age (including adults).
- No curative treatment option
- Time from last chemotherapy (at least 2 chemotherapy cycles) to enrollment <8 weeks
- 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
- 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
- Pregnancy/lactation
- Prior treatment with somatostatin analog
- 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
- Therapeutic anticoagulation which cannot be paused temporarily in order to ensure safe intramuscular injection
- Is taking or requiring any of the prohibited medication listed in 6.4.2
- Heart rate at rest < 60/min
- fasting glucose level > 110mg/dl
- Severe neurologic or psychiatric disorder
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.