Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

Sponsor
Morten Mau-Soerensen
Study ID
NCT03466827
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Thymic Epithelial Tumour
  • Thymoma

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Selinexor 60 mg oral tablets will be administered twice weekly, either Monday/Wednesday or on Tuesday/Thursday or on Wednesday/Friday in a 3-weeks-on and 1-week-off Schedule.

Study Details

The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (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
Oct 12, 2017
Status verified
Mar 2018
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020

Study Design

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

Primary Outcome Measure

Overall Response Rate [ Time Frame: 24 months ]

Central Contacts

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