Phase I-II, randomized, open-label, multicenter, international clinical trial Patients with advanced soft-tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft-part sarcoma) and osteosarcoma will receive selinexor in combination with gemcitabine.
Phase I-II, randomized, open-label, multicenter, international clinical trial Patients with advanced soft-tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft-part sarcoma) and osteosarcoma 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 4 different cohorts: Cohort 1: Undifferentiated pleomorphic sarcoma (UPS) Cohort 2: Leiomyosarcoma (LMS) Cohort 3: Alveolar soft-part sarcoma (ASPS) Cohort 4: Osteosarcoma Patients will be randomized for phase II part only (except in cohort 3) in an open-label way to receive selinexor in combination with gemcitabine versus gemcitabine alone
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
For both interventional ( Selinexor and Gencitabine) Dose-limiting toxicity (DLT) will be applied only to either of the following toxicities occurring during the first treatment cycle (days 1-21).
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
ACTIVE_NOT_RECRUITINGHU Vall d'Hebron
Barcelona, Spain
RECRUITINGH. Fundación Jiménez Díaz
Madrid, Spain
RECRUITINGMaximum tolerated dose (MTD)
To determine the maximum tolerated dose (MTD) or the recommended dose for phase II of Selinexor plus gemcitabine.
Time frame: 6 months
Safety profile according to CTCAE 5.0.
Safety profile of the experimental treatment, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests.
Time frame: 6 months
Objective response rate (ORR).
Objective Response Rate (ORR): ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects (according to RECIST 1.1 criteria).
Time frame: 6 months
Evaluate efficacy according to Choi response
Efficacy measured through tumor response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
Time frame: 6 months
Patients's quality of life (QoL)
Quality of life will be measured with European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire 30
Time frame: 6 months
Pharmacokinetic values in blood analysis
Impact of pharmacokinetics. interactions between selinexor in gemcitabine
Time frame: 6 months
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Hospital Clínico San Carlos
Madrid, Spain
RECRUITINGHospital Universitario La Paz
Madrid, Spain
RECRUITINGHospital Universitario Miguel Servet
Zaragoza, Spain
RECRUITING