Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma

Who is this study for? Patients with selected advanced soft-tissue sarcoma and osteosarcoma
What treatments are being studied? Selinexor
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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/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

⁃ 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.

Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
ACTIVE_NOT_RECRUITING
Barcelona
HU Vall d'Hebron
RECRUITING
Barcelona
H. Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Patricio Ledesma
ensayos@sofpromed.com
971 439 900
Backup
Gabriel Joan Viver Llompart
gviver@sofpromed.com
971 439 900
Time Frame
Start Date: 2020-09-02
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 14
Treatments
Experimental: Selinexor + Gemcitabine
Dose escalation levels (Phase I):~All included patients will take both drugs:~Selinexor weekly (given on days 1,8 and 15 of each cycle) will be dispensed at different dose levels: dose level 1:60 mg, dose level 2: 60 mg, dose level 3: 60 mg, and dose level 4: 80 mg).~Gemcitabine weekly (given on days 1, 8 of each cycle) will be administered at different dose levels: (dose level 1:1000 mg/m2 (30 min), dose level 2:1000 mg/m2 (10 mg/m2/min), dose level 3:1200 mg/m2 (10 mg/m2/min) and dose level 4: 1200 mg/m2 (10 mg/m2/min)).~Selinexor: tablet (20 mg tablets) Oral use.~Gemcitabine: Concentrate for solution for infusion. Intravenous use.
Related Therapeutic Areas
Sponsors
Leads: Grupo Espanol de Investigacion en Sarcomas

This content was sourced from clinicaltrials.gov