SeliSarc

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

Agent: Selinexor (KPT-330) in
combination with gemcitabine
Phase I/II
Status Recruiting
Sponsor SELNET

 

For further information please also consult https://www.clinicaltrials.gov/study/NCT06114004

This is a Phase I-II trial, assessing safety and toxicity as well as early efficacy data of a combination therapy with Selinexor (KPT-330) and gemcitabine, in patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor).

The trial is open-label and not randomized (all patients will receive the same treatment).

 

WHO is the trial for?
  • Adult patients with good overall health status (ECOG 0-1)
  • Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor).
  • Metastatic/advanced disease in progression in the last 6 months.
  • 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.
  • Excluded is a history of three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease.
  • Additional medical eligibility criteria apply and are reviewed by the study team

WHAT is the key question that this trial is attempting to answer?

 This trial evaluates the safety and toxicity of the combination therapy (selinexor/gemcitabine) and the determination of the best tolerable dose, in patients with advanced soft tissue sarcomas.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is currently being conducted in Spain. For further information check here.

Contact:
Name: Patricio Ledesma
Phone Number: 971 439 900 ext +34
Email: ensayos@sofpromed.com

Name: Inés Torrens
Phone Number: 971 439 900 ext +34
Email: itorrens@sofpromed.com

STUDY DESIGN: What does the study look like?

 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 is 60 mg Selinexor.

In the Phase II part there are 2 different cohorts:

Cohort 1: Leiomyosarcoma (LMS)
Cohort 2: Malignant peripheral nerve sheath tumor (MPNST)

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

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken