Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario de Donostia
NOT_YET_RECRUITING
Donostia / San Sebastian
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clínico Universitario Virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Hospital Universitario de Canarias
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Hospital Clinico Universitario Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Patricio Ledesma
ensayos@sofpromed.com
971 439 900
Backup
Inés Torrens
itorrens@sofpromed.com
971 439 900
Time Frame
Start Date: 2023-09-28
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 88
Treatments
Experimental: 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
Sponsors
Leads: Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas

This content was sourced from clinicaltrials.gov

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