Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma
TET-SEL
A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.
1 other identifier
interventional
25
2 countries
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2017
CompletedFirst Submitted
Initial submission to the registry
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedMarch 15, 2018
March 1, 2018
2.7 years
March 9, 2018
March 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
To determine the overall response rate according to RECIST 1.1
24 months
Secondary Outcomes (2)
Progression Free Survival
6 months
Adverse Events
24 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed advanced TET (thymoma or thymic carcinoma)
- Inoperable per local Investigator (Masaoka Stage III or IV)
- Progression after treatment with least one platinum containing chemotherapyregimen
- Measurable disease (RECIST 1.1)
- Age ≥18 years
- ECOG PS \<2
- Patients must have recovered from the toxic effects of prior therapy at the time of initiation of the study drug unless toxicity is stable.
- A 4 weeks interval from any investigational agents or cytotoxic chemotherapy to start of study is required
- Signed informed consent
- Adequate bone marrow function and organ function:
- Hematopoietic function: total white blood cell count (WBC) ≥ 3000/mm³, absolute neutrophil count (ANC) ≥ 1500/mm³, platelet count ≥ 100,000/mm²
- Hepatic function: bilirubin \< 1.5 times the upper limit of normal (ULN), ALT \< 2.5 times ULN or ALT \< 5.0 times ULN in the presence of liver metastases
- Creatinine clearance \> 30 ml/min according to Cockcroft-Gault
- Patients of childbearing potential must agree to use adequate birth control during and for 3 months after participation in this study
You may not qualify if:
- No significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy, including
- Unstable cardiovascular function
- Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
- Markedly decreased visual acuity
- Active infection requiring intravenous antibiotics
- Pregnancy or breast-feeding
- Symptomatic brain metastasis requiring corticosteroids
- Uncontrolled autoimmune disorders. Patients with autoimmune disorders under control on medication may be included. Patients with pure red cell aplasia may be included if haemoglobin levels are relatively stable on transfusions or medication
- Any other cancer (excluding radically operated localised squamous skin cancer) with clinical activity within the last 2 years
- Significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications
- No dehydration of NCI-CTCAE grade ≥ 1
- Serious psychiatric or medical conditions that could interfere with treatment.
- No history of organ allograft
- No concurrent therapy with approved or investigational anticancer therapeutics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morten Mau-Soerensenlead
- Institut Curiecollaborator
- Gustave Roussy, Cancer Campus, Grand Pariscollaborator
- Hospices Civils de Lyoncollaborator
- GSO Global Clinical Research BVcollaborator
- Karyopharm Therapeutics Inccollaborator
Study Sites (4)
Rigshospitalet
Copenhagen, 2100, Denmark
Hospices Civils de Lyon
Lyon, France
Intitut Curie
Paris, France
Intitut Gustave Roussy
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Morten Mau-Soerensen, MD, PhD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician, MD, PhD
Study Record Dates
First Submitted
March 9, 2018
First Posted
March 15, 2018
Study Start
October 12, 2017
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
March 15, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share