Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-28 @ 2:08 AM
Study NCT ID:
NCT06114004
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2023-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
Sponsor:
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Organization:
Study Overview
Official Title:
Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SeliSarc
Brief 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.
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: