Desmoplastic Small Round Cell TumorPhase 2PAMSARCNCT06456359
Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
A Phase 2 study testing Signifor in people with Desmoplastic Small Round Cell Tumor and Synovial Sarcoma, run by University Hospital Heidelberg at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Desmoplastic Small Round Cell Tumor, Synovial Sarcoma
- What is being tested?
- Signifor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesGermany
- Study dates
- 19 Dec 2024to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients meeting all of the following criteria are considered for enrolment into the trial:
- 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
- For patients (≥16 years): Karnofsky-Index ≥ 80% For patients (<16 years): Lansky-Index ≥ 80%
Show all 30Show fewer
- No curative treatment option
- Bodyweight ≥ 30kg and BSA ≥ 1.1m²
- Time from last chemotherapy (at least 2 chemotherapy cycles) to enrollment <8 weeks
- Ability of patient to understand character and individual consequences of the clinical trial
- Written informed consent (for individuals <18 years of age an ICF for adolescents and their parents is needed)
- 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
- Evidence of childbearing potential is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile
- Postmenopausal or evidence of non-childbearing status is defined as:
- Amenorrhea for 1 year or more without an alternative medical cause following cessation of exogenous hormonal treatments plus follicle stimulating hormone (FSH) levels in the postmenopausal range in women not using hormonal contraception or hormonal replacement therapy.
- Chemotherapy-induced menopause
- Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, total hysterectomy or tubal ligation at least 6 weeks before IMP treatment)
- A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
- 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:
- Hemoglobin ≥ 10 g/dl
- Neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/µl
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- ALT and AST ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- PT-INR/PTT ≤ 1.5 x ULN
- Albumin ≥ 25 g/l
- Creatine kinase ≤ 2.5 x ULN
- Serum creatinine < or = 1.5 mg/dl or creatinine clearance = or > 51 ml/min (calculation according to Crockroft-Gault)
Who cannot join
- Patients presenting with any of the following criteria are not included in the trial:
- 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
- Therapeutic anticoagulation which cannot be paused temporarily in order to ensure safe intramuscular injection
Show all 13Show fewer
- Is taking or requiring any of the prohibited medication listed in Table 5 (6.4.2)
- Heart rate at rest < 60/min
- fasting glucose level > 110mg/dl
- Severe neurologic or psychiatric disorder
- Pregnancy/lactation
- Prior treatment with somatostatin analog
- -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Not yet recruiting
Universitätsklinikum Essen Pädiatrische Hämatologie und Onkologie
Essen, North Rhine-Westphalia, 45147
Katrin Menke, +49 201 / 723-2361, Katrin.Menke@uk-essen.de
ewing@uk-essen.de
- Recruiting
National Center for Tumour Diseases, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Editha Gnutzmann, M.A., +49 6221 5636235, e.gnutzmann@nct-heidelberg.de
pamsarc@nct-heidelberg.de
- Not yet recruiting
Klinikum Stuttgart- Olga Hospital Zentrum für Kinder-, Jugend und Frauenmedizin
Stuttgart, Baden-Wurttemberg, 70174
Katrin Apel, +49 711/278-72514, k.apel@klinikum-stuttgart.de
Monika Sparber-Sauer, Prof. Dr. med.
- Not yet recruiting
Klinikum Stuttgart Studienzentrale Stuttgart Cancer Center, Tumorzentrum Eva-Mayr-Stihl
Stuttgart, Baden-Wurttemberg, 70175
Stephanie Waldvogel, +49 711/ 278-54984, s.waldvogel@klinikum-stuttgart.de
Elke Valk, Doctor, +49 711/ 278 30414, e.valk@klinikum-stuttgart.de
About this study
Official title: Pasireotide as Maintenance Treatment With Monthly Deep Intramuscular Injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
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.
Read more
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.
Read the detailed description
Desmoplastic small round cell tumor (DSRCT) is an extremely rare, aggressive sarcoma. It originates from the serosal surface of the abdominal cavity and the hallmark characteristic of DSRCT is the EWSR1-WT1 gene fusion. Synovial sarcoma (SySa) is also a rare fusion-gene driven (SS18-SSX1, SS18-SSX2, or rarely, SS18-SSX4) soft-tissue sarcoma.
Selected somatostatin receptor (SSTR) family members, i.e., SSTR2, SSTR3 and SSTR5, were highly expressed in patients with available transcriptome data, providing the basis for treatment with a somatostatin analog such as pasireotide with high affinity for SSTR1, 2, 3, and 5.
The primary aim of the study is to assess the clinical efficacy of pasireotide maintenance therapy for prolonging progression-free (PFS) and overall survival (OS) in patients with SSTR2/3/5-expressing advanced SySa and DSRCT. Furthermore measurable residual disease (MRD) before, during, and after pasireotide maintenance therapy are assessed. Pasireotide is applied in adults with 60 mg and in adolescents 60 mg (body surface area [BSA] >1.6 m²) or 40 mg (BSA 1.1-1.6 m²) via intragluteal via intragluteal depot injection every 28±3 days. The sample size is planned for the entire study population with subsequent sensitivity analysis in two subgroups, i.e., adolescents and adults. The primary efficacy analysis is be based on a two-sided, one-sample log-rank test using a significance level of 5%. The sample size was calculated assuming exponential data, planning for a power of 90% to detect a hazard ratio of 0.5. With a sample size of n=28, the expected number of events during the study is 22. Safety is assessed continuously according to CTCAE v5.0. The recruitment period is planned for 2 years starting in 2024 followed by a minimal follow-up of the last patient of 6 months leading to estimated trial completion in 2027.
- Being tested
- Signifor
- Keywords
- SSTR, somatostatin receptor, SSTR2, SSTR3, SSTR5, somatostatin analog, pasireotide, fusion-gene driven, SS18-SSX1, SS18-SSX2, SS18-SSX4, EWSR1-WT1, extremely rare, aggressive sarcoma, maintaince therapy
- Medical subject headings
- Desmoplastic Small Round Cell Tumor, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SigniforDrug
Also called ATC-Code: H01CB05
Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate). Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).
| Study group | Role | What they receive |
|---|---|---|
| Pasireotid treatment single arm | Experimental | Adults receive 60 mg via intragluteal depot injection every 28±3 days, adolescents 60 mg (body surface area [BSA] >1.6 m²) or 40 mg (BSA 1.1-1.6 m2) via intragluteal depot injection every 28±3 days. Receives: Drug: Signifor |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Assessment of clinical efficacy of pasireotide maintenance therapy
Measured: 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 years
Secondary outcomes (1)
overall survival (OS)
Assessment of clinical efficacy of pasireotide maintenance therapy
Measured: 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 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start19 Dec 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Desmoplastic Small Round Cell TumorStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm prospective, open label, multi-centre phase II study of pasireoide maintenance therapy in patients with advanced/metastatic DSRCT and SySa. According to the staggered approach during a run-in phase feasibility is assessed in 3 (or, if necessary, more) adult patients before initiating recruitment in adolescents. Adults receive 60 mg via intragluteal depot injection every 28±3 days, adolescents 60 mg (body surface area \[BSA\] \>1.6 m²) or 40 mg (BSA 1.1-1.6 m2) via intragluteal depot injection every 28±3 days.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Richard F Schlenk, University Hospital Heidelberg
- Investigators
- Richard F. Schlenk, Professor, Principal investigator, National Center for Tumour Diseases, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456359
- Sponsor's protocol ID
- PAMSARC
- Acronym
- PAMSARC
- Status last verified
- Jan 2025
- First submitted
- 22 May 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heilig CE, Heining C, Gnutzmann E, Roldan S, Heiligenthal L, Sparber-Sauer M, Hahn D, Dirksen U, Hamacher R, Florcken A, Thorwarth A, Deinzer CKW, Gaidzik VI, Pfaff E, Hubschmann D, Arndt K, Pfister SM, Glimm H, Frohling S, Schlenk RF. Rationale and design of the PAMSARC (pasireotide as maintenance treatment with monthly deep intramuscular injection in SSTR2/3/5-expressing synovial sarcoma and desmoplastic small round cell tumor) multicenter phase 2 trial. Cancer Treat Res Commun. 2025;45:100986. doi: 10.1016/j.ctarc.2025.100986. Epub 2025 Sep 3.
PubMed 40934647
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pasireotide as Maintenance Treatment With Monthly Deep Intramuscular Injection in SSTR2/3/5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
- ClinicalTrials.gov ID
- NCT06456359
- Acronym / sponsor ID
- PAMSARC / PAMSARC
- Keywords
- SSTR, somatostatin receptor, SSTR2, SSTR3, SSTR5, somatostatin analog, pasireotide, fusion-gene driven, SS18-SSX1, SS18-SSX2, SS18-SSX4, EWSR1-WT1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Desmoplastic small round cell tumor (DSRCT) is an extremely rare, aggressive sarcoma. It originates from the serosal surface of the abdominal cavity and the hallmark characteristic of DSRCT is the EWSR1-WT1 gene fusion. Synovial sarcoma (SySa) is also a rare fusion-gene driven (SS18-SSX1, SS18-SSX2, or rarely, SS18-SSX4) soft-tissue sarcoma.
Selected somatostatin receptor (SSTR) family members, i.e., SSTR2, SSTR3 and SSTR5, were highly expressed in patients with available transcriptome data, providing the basis for treatment with a somatostatin analog such as pasireotide with high affinity for SSTR1, 2, 3, and 5.
The primary aim of the study is to assess the clinical efficacy of pasireotide maintenance therapy for prolonging progression-free (PFS) and overall survival (OS) in patients with SSTR2/3/5-expressing advanced SySa and DSRCT. Furthermore measurable residual disease (MRD) before, during, and after pasireotide maintenance therapy are assessed. Pasireotide is applied in adults with 60 mg and in adolescents 60 mg (body surface area [BSA] >1.6 m²) or 40 mg (BSA 1.1-1.6 m²) via intragluteal via intragluteal depot injection every 28±3 days. The sample size is planned for the entire study population with subsequent sensitivity analysis in two subgroups, i.e., adolescents and adults. The primary efficacy analysis is be based on a two-sided, one-sample log-rank test using a significance level of 5%. The sample size was calculated assuming exponential data, planning for a power of 90% to detect a hazard ratio of 0.5. With a sample size of n=28, the expected number of events during the study is 22. Safety is assessed continuously according to CTCAE v5.0. The recruitment period is planned for 2 years starting in 2024 followed by a minimal follow-up of the last patient of 6 months leading to estimated trial completion in 2027.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm prospective, open label, multi-centre phase II study of pasireoide maintenance therapy in patients with advanced/metastatic DSRCT and SySa. According to the staggered approach during a run-in phase feasibility is assessed in 3 (or, if necessary, more) adult patients before initiating recruitment in adolescents. Adults receive 60 mg via intragluteal depot injection every 28±3 days, adolescents 60 mg (body surface area [BSA] >1.6 m²) or 40 mg (BSA 1.1-1.6 m2) via intragluteal depot injection every 28±3 days.
| Arm | Type | Receives |
|---|---|---|
| Pasireotid treatment single arm | Experimental | Drug: SigniforAdults receive 60 mg via intragluteal depot injection every 28±3 days, adolescents 60 mg (body surface area [BSA] >1.6 m²) or 40 mg (BSA 1.1-1.6 m2) via intragluteal depot injection every 28±3 days. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (30 listed)
- Patients meeting all of the following criteria are considered for enrolment into the trial:
- 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
Key exclusion criteria (13 listed)
- 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
- Therapeutic anticoagulation which cannot be paused temporarily in order to ensure safe intramuscular injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SigniforAlso: ATC-Code: H01CB05Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate). Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate). | Drug | Pasireotid treatment single arm |
Primary outcome
progression-free survival (PFS)
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 years
Assessment of clinical efficacy of pasireotide maintenance therapy
1 secondary outcome
overall survival (OS)
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 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 40934647Heilig CE, Heining C, Gnutzmann E, Roldan S, Heiligenthal L, Sparber-Sauer M, Hahn D, Dirksen U, Hamacher R, Florcken A, Thorwarth A, Deinzer CKW, Gaidzik VI, Pfaff E, Hubschmann D, Arndt K, Pfister SM, Glimm H, Frohling S, Schlenk RF. Rationale and design of the PAMSARC (pasireotide as maintenance treatment with monthly deep intramuscular injection in SSTR2/3/5-expressing synovial sarcoma and desmoplastic small round cell tumor) multicenter phase 2 trial. Cancer Treat Res Commun. 2025;45:100986. doi: 10.1016/j.ctarc.2025.100986. Epub 2025 Sep 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard F. Schlenk, Professor principal investigator
National Center for Tumour Diseases, University Hospital Heidelberg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Signifor in people with Desmoplastic Small Round Cell Tumor and Synovial Sarcoma, run by University Hospital Heidelberg at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard F. Schlenk, Professor (+49 (0)6221 56 6228, richard.schlenk@nct-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (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 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.