CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 14 target
Drug / intervention
Selinexordrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Histologically confirmed soft tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft part sarcoma) or osteosarcoma
  • ✓Metastatic or advanced disease with progression in last 6 months
  • ✓Prior systemic therapy required (at least one line)
  • ✓Measurable disease by RECIST 1.1
Key exclusion· 10
  • ✕Three or more previous lines of chemotherapy
  • ✕Prior selinexor or XPO1 inhibitor treatment
  • ✕Prior gemcitabine-containing treatment
  • ✕Uncontrolled active infection requiring systemic antimicrobials within 1 week prior to treatment start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04595994
NCT04595994Phase 1RecruitingUpdate OverdueUpdated 29mo ago · Completion was 7mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Grupo Espanol de Investigacion en Sarcomas·interventional·Posted Oct 22, 2020·Updated Jan 23, 2024

In Brief

A Phase 1 clinical trial evaluating Selinexor for Sarcoma,Soft Tissue. Currently recruiting, targeting 14 participants across 6 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma,Soft Tissue
CountriesSpain
Collaborators--

Timeline

Phase 1RecruitingOverdue
202120222023202420252026
First PostedOct 22, 2020
Enrollment StartSep 2, 2020
Primary CompletionNov 30, 2025
Study CompletionMay 31, 2026
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 5.7 years ago

Interventions

Selinexordrug

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).