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

Sponsor
Grupo Espanol de Investigacion en Sarcomas
Study ID
NCT04595994
Phase
PHASE1
Status
Unknown

Conditions

  • Sarcoma,Soft Tissue

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    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).

Study Details

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.

Key Dates

Start date
Sep 2, 2020
Status verified
Jan 2024
Primary completion
Nov 30, 2025
Completion
May 31, 2026

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 6 months ]

Central Contacts

Related Studies