Overview

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)

Status:
Recruiting
Trial end date:
2026-05-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Treatments:
Gemcitabine
Criteria
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.

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)