Trial Title:
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
NCT ID:
NCT06114004
Condition:
Sarcoma,Soft Tissue
Conditions: Official terms:
Sarcoma
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
each cohort (1 and 2) receives the same treatment.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor 20 MG
Description:
After having completed the Phase I part, the recommended dose for Phase II is 60mg
Selinexor
Arm group label:
gemcitabine + selinexor:
Other name:
KPT-330
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21
days.
Arm group label:
gemcitabine + selinexor:
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.
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)
Criteria for eligibility:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario de Canarias
Address:
City:
Tenerife
Zip:
38320
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Josefina MD Cruz
Email:
jcruzjurado@gmail.com
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ana MD Sebio
Email:
ASebio@santpau.cat
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Claudia MD Valverde
Email:
cmvalver@vhebron.net
Facility:
Name:
Hospital Universitario de Donostia
Address:
City:
Donostia
Zip:
20014
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ana MD Paisán
Email:
ana.paisanruiz@osakidetza.eus
Facility:
Name:
Hospital General Universitario Gregorio Marañón
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Rosa MD Álvarez
Email:
rosa.alvarez.al@gmail.com
Facility:
Name:
Hospital Clínico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Antonio MD Casado
Email:
antoniocasado6@gmail.com
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Javier MD Martín Broto
Email:
jmartin@atbsarc.org
Contact backup:
Last name:
Nadia Hindi
Email:
nhindi@atbsarc.org
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Andrés MD Redondo
Email:
aredondo12@gmail.com
Facility:
Name:
Hospital Clínico Universitario Virgen de la Arrixaca
Address:
City:
Murcia
Zip:
30120
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jerónimo MD Martínez
Email:
jeronimo@seom.org
Facility:
Name:
Hospital Clinico Universitario Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Alejandro MD Pérez Fidalgo
Email:
japfidalgo@msn.com
Facility:
Name:
Hospital Universitario Miguel Servet
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Javier MD Martínez Trufero
Email:
jmtrufero@seom.org
Start date:
September 28, 2023
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Agency class:
Other
Source:
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06114004
