Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT03193437
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Thymic Epithelial Tumor
  • Thymoma

Eligibility Criteria

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

Interventions

  • Open Label Selinexor — DRUG
    Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.

Study Details

The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (25 patients): There are two study arms: Arm A: Thymoma * Stage 1: 15 patients * Stage 2: 10 patients Arm B: Thymic carcinoma * Stage 1: 15 patients * Stage 2: 10 patients

Key Dates

Start date
Apr 3, 2018
Status verified
Apr 2022
Primary completion
Jul 27, 2020
Completion
Jan 31, 2022

Study Design

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

Arms

  • Experimental: Selinexor
    Open Label Selinexor 40 mg

Primary Outcome Measure

Overall Response Rate [ Time Frame: 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
John Theurer Cancer Center - Hackensack University Medical CenterHackensackNew Jersey07601-

Find similar trials in Washington D.C., DC

By research site
Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCJohn Theurer Cancer Center - Hackensack University Medical Center· Hackensack, NJ

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