Sarcoma,Soft TissuePhase 2SeliSarcNCT06114004
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
A Phase 2 study testing Selinexor 20 MG and Gemcitabine in people with Sarcoma,Soft Tissue, run by Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas at 11 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sarcoma,Soft Tissue
- What is being tested?
- Selinexor 20 MG and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 11 sitesSpain
- Study dates
- 28 Sep 2023to 31 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age: 18-80 years.
- 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.
- Metastatic/advanced disease in progression in the last 6 months.
- Patients have previously received at least one previous line of systemic therapy.
- Measurable disease according to RECIST 1.1 criteria.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Adequate hepatic, renal, cardiac, and hematologic function.
- 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.
Who cannot join
- Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).
- Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.
- 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.
- Prior selinexor or another XPO1 inhibitor treatment.
- Administration of a previous gemcitabine-containing treatment.
- 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.
Show all 15Show fewer
- 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.
- Pregnant or breastfeeding females.
- Body surface area (BSA) <1.4 m2 at baseline, calculated by the Du Bois(25) or Mosteller(26) method.
- Life expectancy of less than 3 months.
- Major surgery within 4 weeks prior to C1D1.
- Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.
- 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).
- 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)
- Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites, 11 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Ana MD Sebio, ASebio@santpau.cat
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Claudia MD Valverde, cmvalver@vhebron.net
- Not yet recruiting
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014
Ana MD Paisán, ana.paisanruiz@osakidetza.eus
- Not yet recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Rosa MD Álvarez, rosa.alvarez.al@gmail.com
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Antonio MD Casado, antoniocasado6@gmail.com
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Javier MD Martín Broto, jmartin@atbsarc.org
Nadia Hindi, nhindi@atbsarc.org
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Andrés MD Redondo, aredondo12@gmail.com
- Not yet recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Jerónimo MD Martínez, jeronimo@seom.org
- Not yet recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320
Josefina MD Cruz, jcruzjurado@gmail.com
- Not yet recruiting
Hospital Clinico Universitario Valencia
Valencia, 46010
Alejandro MD Pérez Fidalgo, japfidalgo@msn.com
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Javier MD Martínez Trufero, jmtrufero@seom.org
About this study
Official title: Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas
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.
Read the detailed description
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)
- Conditions
- Sarcoma,Soft Tissue
- Being tested
- Selinexor 20 MG, Gemcitabine
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor 20 MGDrug
Also called KPT-330
After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor
GemcitabineDrug
Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine + selinexor: | Experimental | 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 Receives: Drug: Selinexor 20 MG; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival rate (PFSR)
To evaluate the efficacy of the selinexor plus gemcitabine combination as measured by the progression-free survival rate (PFSR) at 6 months in patients with selected advanced soft-tissue sarcomas.
Measured: 6 months
Secondary outcomes (5)
Overall survival (OS)
Overall survival (OS): OS is defined as the time between the date of first dose and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.
Measured: 6 months
Overall response rate (ORR) according to RECIST 1.1
Overall Response Rate (ORR): ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects.
Measured: 6 months
Evaluate the efficacy according to Choi response
Efficacy measured through tumor response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety profile of the experimental treatment, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests. Toxicity will be graded and tabulated by using CTCAE 5.0.
Measured: 6 months
Patients's quality of life (QoL)
Quality of life will be measured with European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire 30
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start28 Sep 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Sarcoma,Soft TissueStudies of the same condition, open and under way.
- 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
- each cohort (1 and 2) receives the same treatment.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier MD Martín Broto, Study director, Hospital Universitario Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114004
- Sponsor's protocol ID
- SELNET-7-1
- Acronym
- SeliSarc
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turner JG, Sullivan DM. CRM1-mediated nuclear export of proteins and drug resistance in cancer. Curr Med Chem. 2008;15(26):2648-55. doi: 10.2174/092986708786242859.
PubMed 18991627Das A, Wei G, Parikh K, Liu D. Selective inhibitors of nuclear export (SINE) in hematological malignancies. Exp Hematol Oncol. 2015 Mar 1;4:7. doi: 10.1186/s40164-015-0002-5. eCollection 2015.
PubMed 25745591Yao Y, Dong Y, Lin F, Zhao H, Shen Z, Chen P, Sun YJ, Tang LN, Zheng SE. The expression of CRM1 is associated with prognosis in human osteosarcoma. Oncol Rep. 2009 Jan;21(1):229-35.
PubMed 19082467Gravina GL, Senapedis W, McCauley D, Baloglu E, Shacham S, Festuccia C. Nucleo-cytoplasmic transport as a therapeutic target of cancer. J Hematol Oncol. 2014 Dec 5;7:85. doi: 10.1186/s13045-014-0085-1.
PubMed 25476752Abdul Razak AR, Mau-Soerensen M, Gabrail NY, Gerecitano JF, Shields AF, Unger TJ, Saint-Martin JR, Carlson R, Landesman Y, McCauley D, Rashal T, Lassen U, Kim R, Stayner LA, Mirza MR, Kauffman M, Shacham S, Mahipal A. First-in-Class, First-in-Human Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Dec;34(34):4142-4150. doi: 10.1200/JCO.2015.65.3949. Epub 2016 Oct 31.
PubMed 26926685Gounder MM, Zer A, Tap WD, Salah S, Dickson MA, Gupta AA, Keohan ML, Loong HH, D'Angelo SP, Baker S, Condy M, Nyquist-Schultz K, Tanner L, Erinjeri JP, Jasmine FH, Friedlander S, Carlson R, Unger TJ, Saint-Martin JR, Rashal T, Ellis J, Kauffman M, Shacham S, Schwartz GK, Abdul Razak AR. Phase IB Study of Selinexor, a First-in-Class Inhibitor of Nuclear Export, in Patients With Advanced Refractory Bone or Soft Tissue Sarcoma. J Clin Oncol. 2016 Sep 10;34(26):3166-74. doi: 10.1200/JCO.2016.67.6346. Epub 2016 Jul 25.
PubMed 27458288Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Groschel S, Hatcher H, Duffaud F, Herraez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Gotze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.
PubMed 35394800Ishizawa J, Kojima K, Hail N Jr, Tabe Y, Andreeff M. Expression, function, and targeting of the nuclear exporter chromosome region maintenance 1 (CRM1) protein. Pharmacol Ther. 2015 Sep;153:25-35. doi: 10.1016/j.pharmthera.2015.06.001. Epub 2015 Jun 3.
PubMed 26048327De Cesare M, Cominetti D, Doldi V, Lopergolo A, Deraco M, Gandellini P, Friedlander S, Landesman Y, Kauffman MG, Shacham S, Pennati M, Zaffaroni N. Anti-tumor activity of selective inhibitors of XPO1/CRM1-mediated nuclear export in diffuse malignant peritoneal mesothelioma: the role of survivin. Oncotarget. 2015 May 30;6(15):13119-32. doi: 10.18632/oncotarget.3761.
PubMed 25948791Nakayama R, Zhang YX, Czaplinski JT, Anatone AJ, Sicinska ET, Fletcher JA, Demetri GD, Wagner AJ. Preclinical activity of selinexor, an inhibitor of XPO1, in sarcoma. Oncotarget. 2016 Mar 29;7(13):16581-92. doi: 10.18632/oncotarget.7667.
PubMed 26918731Moysan E, Bastiat G, Benoit JP. Gemcitabine versus Modified Gemcitabine: a review of several promising chemical modifications. Mol Pharm. 2013 Feb 4;10(2):430-44. doi: 10.1021/mp300370t. Epub 2012 Oct 8.
PubMed 22978251Plunkett W, Huang P, Gandhi V. Preclinical characteristics of gemcitabine. Anticancer Drugs. 1995 Dec;6 Suppl 6:7-13. doi: 10.1097/00001813-199512006-00002.
PubMed 8718419Siena L, Pace E, Ferraro M, Di Sano C, Melis M, Profita M, Spatafora M, Gjomarkaj M. Gemcitabine sensitizes lung cancer cells to Fas/FasL system-mediated killing. Immunology. 2014 Feb;141(2):242-55. doi: 10.1111/imm.12190.
PubMed 24128051Garcia-Del-Muro X, Lopez-Pousa A, Maurel J, Martin J, Martinez-Trufero J, Casado A, Gomez-Espana A, Fra J, Cruz J, Poveda A, Meana A, Pericay C, Cubedo R, Rubio J, De Juan A, Lainez N, Carrasco JA, de Andres R, Buesa JM; Spanish Group for Research on Sarcomas. Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study. J Clin Oncol. 2011 Jun 20;29(18):2528-33. doi: 10.1200/JCO.2010.33.6107. Epub 2011 May 23.
PubMed 21606430Sonnenblick A, Eleyan F, Peretz T, Ospovat I, Merimsky O, Sella T, Peylan-Ramu N, Katz D. Gemcitabine in combination with paclitaxel for advanced soft-tissue sarcomas. Mol Clin Oncol. 2015 Jul;3(4):829-832. doi: 10.3892/mco.2015.545. Epub 2015 Apr 16.
PubMed 26171190
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas
- ClinicalTrials.gov ID
- NCT06114004
- Acronym / sponsor ID
- SeliSarc / SELNET-7-1
- Conditions
- Sarcoma,Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Asociación Europea y Latinoamericana SELNET para la Investigación en SarcomasUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 2 Nov 2023 (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.
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.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- each cohort (1 and 2) receives the same treatment.
| Arm | Type | Receives |
|---|---|---|
| gemcitabine + selinexor: | Experimental | Drug: Selinexor 20 MG, Drug: GemcitabineSelinexor 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Age: 18-80 years.
- 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.
- Metastatic/advanced disease in progression in the last 6 months.
- Patients have previously received at least one previous line of systemic therapy.
Key exclusion criteria (15 listed)
- Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).
- Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.
- 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.
- Prior selinexor or another XPO1 inhibitor treatment.
- Administration of a previous gemcitabine-containing treatment.
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 |
|---|---|---|
| Selinexor 20 MGAlso: KPT-330After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor | Drug | gemcitabine + selinexor: |
| GemcitabineGemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days. | Drug | gemcitabine + selinexor: |
Primary outcome
progression-free survival rate (PFSR)
Time frame: 6 months
To evaluate the efficacy of the selinexor plus gemcitabine combination as measured by the progression-free survival rate (PFSR) at 6 months in patients with selected advanced soft-tissue sarcomas.
5 secondary outcomes
Overall survival (OS)
Time frame: 6 months
Overall response rate (ORR) according to RECIST 1.1
Time frame: 6 months
Evaluate the efficacy according to Choi response
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 6 months
Patients's quality of life (QoL)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 18991627Turner JG, Sullivan DM. CRM1-mediated nuclear export of proteins and drug resistance in cancer. Curr Med Chem. 2008;15(26):2648-55. doi: 10.2174/092986708786242859.
- Background: PubMed 25745591Das A, Wei G, Parikh K, Liu D. Selective inhibitors of nuclear export (SINE) in hematological malignancies. Exp Hematol Oncol. 2015 Mar 1;4:7. doi: 10.1186/s40164-015-0002-5. eCollection 2015.
- Background: PubMed 19082467Yao Y, Dong Y, Lin F, Zhao H, Shen Z, Chen P, Sun YJ, Tang LN, Zheng SE. The expression of CRM1 is associated with prognosis in human osteosarcoma. Oncol Rep. 2009 Jan;21(1):229-35.
- Background: PubMed 25476752Gravina GL, Senapedis W, McCauley D, Baloglu E, Shacham S, Festuccia C. Nucleo-cytoplasmic transport as a therapeutic target of cancer. J Hematol Oncol. 2014 Dec 5;7:85. doi: 10.1186/s13045-014-0085-1.
- Background: PubMed 26926685Abdul Razak AR, Mau-Soerensen M, Gabrail NY, Gerecitano JF, Shields AF, Unger TJ, Saint-Martin JR, Carlson R, Landesman Y, McCauley D, Rashal T, Lassen U, Kim R, Stayner LA, Mirza MR, Kauffman M, Shacham S, Mahipal A. First-in-Class, First-in-Human Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Dec;34(34):4142-4150. doi: 10.1200/JCO.2015.65.3949. Epub 2016 Oct 31.
- Background: PubMed 27458288Gounder MM, Zer A, Tap WD, Salah S, Dickson MA, Gupta AA, Keohan ML, Loong HH, D'Angelo SP, Baker S, Condy M, Nyquist-Schultz K, Tanner L, Erinjeri JP, Jasmine FH, Friedlander S, Carlson R, Unger TJ, Saint-Martin JR, Rashal T, Ellis J, Kauffman M, Shacham S, Schwartz GK, Abdul Razak AR. Phase IB Study of Selinexor, a First-in-Class Inhibitor of Nuclear Export, in Patients With Advanced Refractory Bone or Soft Tissue Sarcoma. J Clin Oncol. 2016 Sep 10;34(26):3166-74. doi: 10.1200/JCO.2016.67.6346. Epub 2016 Jul 25.
- Background: PubMed 35394800Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Groschel S, Hatcher H, Duffaud F, Herraez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Gotze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.
- Background: PubMed 26048327Ishizawa J, Kojima K, Hail N Jr, Tabe Y, Andreeff M. Expression, function, and targeting of the nuclear exporter chromosome region maintenance 1 (CRM1) protein. Pharmacol Ther. 2015 Sep;153:25-35. doi: 10.1016/j.pharmthera.2015.06.001. Epub 2015 Jun 3.
- Background: PubMed 25948791De Cesare M, Cominetti D, Doldi V, Lopergolo A, Deraco M, Gandellini P, Friedlander S, Landesman Y, Kauffman MG, Shacham S, Pennati M, Zaffaroni N. Anti-tumor activity of selective inhibitors of XPO1/CRM1-mediated nuclear export in diffuse malignant peritoneal mesothelioma: the role of survivin. Oncotarget. 2015 May 30;6(15):13119-32. doi: 10.18632/oncotarget.3761.
- Background: PubMed 26918731Nakayama R, Zhang YX, Czaplinski JT, Anatone AJ, Sicinska ET, Fletcher JA, Demetri GD, Wagner AJ. Preclinical activity of selinexor, an inhibitor of XPO1, in sarcoma. Oncotarget. 2016 Mar 29;7(13):16581-92. doi: 10.18632/oncotarget.7667.
- Background: PubMed 22978251Moysan E, Bastiat G, Benoit JP. Gemcitabine versus Modified Gemcitabine: a review of several promising chemical modifications. Mol Pharm. 2013 Feb 4;10(2):430-44. doi: 10.1021/mp300370t. Epub 2012 Oct 8.
- Background: PubMed 8718419Plunkett W, Huang P, Gandhi V. Preclinical characteristics of gemcitabine. Anticancer Drugs. 1995 Dec;6 Suppl 6:7-13. doi: 10.1097/00001813-199512006-00002.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Javier MD Martín Broto study director
Hospital Universitario Fundación Jiménez Díaz
11 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 Selinexor 20 MG and Gemcitabine in people with Sarcoma,Soft Tissue, run by Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas at 11 sites in Spain.
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 15 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricio Ledesma (971 439 900 ext. +34, ensayos@sofpromed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival rate (PFSR) (time frame: 6 months). 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 NCT06114004, which also lists 48 linked publications.
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 25 Jun 2025.