Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
NCT ID: NCT06114004
Last Updated: 2025-06-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-28
Study Completion Date
2026-05-31
Brief Summary
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Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial.
Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.
Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.
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Detailed Description
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Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial.
Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.
In the Phase I part safety and toxicity of the combination will be assessed using a 3+3 design. The recommended dose for the Phase II will be determined.
In the Phase II part there will be 2 different cohorts:
Cohort 1: Leiomyosarcoma (LMS) Cohort 2: Malignant peripheral nerve sheath tumor (MPNST)
Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.
In the Phase I part safety and toxicity of the combination will be assessed using a 3+3 design. The recommended dose for the Phase II will be determined.
In the Phase II part there will be 2 different cohorts:
Cohort 1: Leiomyosarcoma (LMS) Cohort 2: Malignant peripheral nerve sheath tumor (MPNST)
Conditions
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Sarcoma,Soft Tissue
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
each cohort (1 and 2) receives the same treatment.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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gemcitabine + selinexor:
Selinexor will be given at 60 mg once per week orally days 1, 8 and 15 every 21 days
Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days
Group Type
EXPERIMENTAL
Selinexor 20 MG
Intervention Type
DRUG
After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor
Gemcitabine
Intervention Type
DRUG
Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days.
Interventions
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Selinexor 20 MG
After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor
Intervention Type
DRUG
Gemcitabine
Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days.
Intervention Type
DRUG
Other Intervention Names
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KPT-330
Eligibility Criteria
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Inclusion Criteria
1. Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. imaging tests), obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
2. Age: 18-80 years.
3. Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior to enrolment with an archive tumor sample. A fresh paraffin embedded tumor tissue block must be provided for all subjects for biomarker analysis before and (when feasible) after treatment with investigational products.
4. Metastatic/advanced disease in progression in the last 6 months.
5. Patients have previously received at least one previous line of systemic therapy.
6. Measurable disease according to RECIST 1.1 criteria.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
8. Adequate hepatic, renal, cardiac, and hematologic function.
9. Laboratory tests as follows:
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan.
11\. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and agree to use birth control measures during study treatment and for 3 months after its completion. Patients must not be pregnant or nursing at study entry. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
2. Age: 18-80 years.
3. Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior to enrolment with an archive tumor sample. A fresh paraffin embedded tumor tissue block must be provided for all subjects for biomarker analysis before and (when feasible) after treatment with investigational products.
4. Metastatic/advanced disease in progression in the last 6 months.
5. Patients have previously received at least one previous line of systemic therapy.
6. Measurable disease according to RECIST 1.1 criteria.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
8. Adequate hepatic, renal, cardiac, and hematologic function.
9. Laboratory tests as follows:
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan.
11\. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and agree to use birth control measures during study treatment and for 3 months after its completion. Patients must not be pregnant or nursing at study entry. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
Exclusion Criteria
1. Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).
2. Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.
3. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 5 years prior to randomization. Cancer treated with curative intent for \>5 years previously and without evidence of recurrence will be allowed.
4. Prior selinexor or another XPO1 inhibitor treatment.
5. Administration of a previous gemcitabine-containing treatment.
6. Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
8. Pregnant or breastfeeding females.
9. Body surface area (BSA) \<1.4 m2 at baseline, calculated by the Du Bois(25) or Mosteller(26) method.
10. Life expectancy of less than 3 months.
11. Major surgery within 4 weeks prior to C1D1.
12. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.
13. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia/cachexia (palliative care).
14. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. 15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
2. Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.
3. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 5 years prior to randomization. Cancer treated with curative intent for \>5 years previously and without evidence of recurrence will be allowed.
4. Prior selinexor or another XPO1 inhibitor treatment.
5. Administration of a previous gemcitabine-containing treatment.
6. Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
8. Pregnant or breastfeeding females.
9. Body surface area (BSA) \<1.4 m2 at baseline, calculated by the Du Bois(25) or Mosteller(26) method.
10. Life expectancy of less than 3 months.
11. Major surgery within 4 weeks prior to C1D1.
12. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.
13. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia/cachexia (palliative care).
14. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. 15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Javier MD Martín Broto
Role: STUDY_DIRECTOR
Hospital Universitario Fundación Jiménez Díaz
Locations
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Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Site Status
NOT_YET_RECRUITING
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitario de Donostia
Donostia / San Sebastian, , Spain
Site Status
NOT_YET_RECRUITING
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Clínico San Carlos
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario La Paz
Madrid, , Spain
Site Status
RECRUITING
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Clinico Universitario Valencia
Valencia, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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SELNET-7-1
Identifier Type: -
Identifier Source: org_study_id
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