Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    14
  • sponsor
    Grupo Espanol de Investigacion en Sarcomas
Updated on 25 November 2021
platelet count
systemic therapy
measurable disease
anthracyclines
neutrophil count
gemcitabine
soft tissue sarcoma
undifferentiated pleomorphic sarcoma
leiomyosarcoma
alveolar soft part sarcoma

Summary

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.

Description

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

Details
Condition Sarcoma (Pediatric), Sarcoma, Soft Tissue Sarcoma
Treatment Selinexor
Clinical Study IdentifierNCT04595994
SponsorGrupo Espanol de Investigacion en Sarcomas
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft part sarcoma) or osteosarcoma 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/mm
Platelet count 100,000/mm
Bilirubin 1.5 mg/dL
AST and ALT 2.5 times upper limit of normal
Creatinine 1.5 mg/dL
Left ventricular ejection fraction 50% by echocardiogram or MUGA scan
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

Three or more previous lines of chemotherapy
Prior selinexor or another XPO1 inhibitor treatment
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
Administration of a previous gemcitabine-containing treatment
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
Pregnant or breastfeeding females
Life expectancy of less than 3 months
Body surface area (BSA) <1.4 m2 at baseline, calculated by the Du Bois(31) or osteller(32) method
Major surgery within 4 weeks prior to C1D1
Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment
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)
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
Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
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