Study of Selinexor and Doxorubicin in Advanced Soft Tissue Sarcomas

Sponsor
University Health Network, Toronto
Study ID
NCT03042819
Phase
PHASE1
Status
Completed

Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor is a Selective Inhibitor of Nuclear Export (SINE) compound that binds and inactivates Exportin 1 (XPO1), thereby forcing the nuclear retention of key tumor suppressor proteins (TSPs).
  • Doxorubicin — DRUG
    Doxorubicin is currently approved for various cancers. Doxorubicin inhibits DNA synthesis and repair by inhibiting topoisomerase II and also by intercalation between base pairs on the DNA helix. These actions result in the blockade of DNA and RNA synthesis and fragmentation of DNA.

Study Details

This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study is to determine how safe and tolerable the combination is, as well as the best dose of the study drugs in this patient population. Selinexor (also called KPT-330), works by trapping "tumor suppressor proteins" within the cell and thus causing the cancer cells to die or stop growing.

Key Dates

Start date
May 16, 2017
Status verified
Nov 2021
Primary completion
Nov 30, 2019
Completion
Jun 30, 2021

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor plus Doxorubicin
    Selinexor will be given by mouth (orally) once a week: Dose Level -1 = 40 mg Dose Level 1 (Starting Dose) = 60 mg Dose Level 2 = 80 mg Doxorubicin will be given by vein (intravenously) at a dose of 75 mg/m2 once every 3 weeks.

Primary Outcome Measure

To evaluate the Incidence of Treatment-Emergent Adverse Events, graded and categorized according to the CTCAE v4.0. [ Time Frame: 3 years ]

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