TET-SEL: Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

Sponsor

Morten Mau-Soerensen (Other)

Overall Status

Unknown status

CT.gov ID

NCT03466827

Collaborator

Institut Curie (Other), Gustave Roussy, Cancer Campus, Grand Paris (Other), Hospices Civils de Lyon (Other), GSO Global Clinical Research BV (Other), Karyopharm Therapeutics Inc (Industry)

Enrollment

Locations

32.6

Anticipated Duration (Months)

6.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Thymoma Advanced Thymic Epithelial Tumour	Drug: Selinexor	Phase 2

Detailed Description

Not provided

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.

Actual Study Start Date :

Oct 12, 2017

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Outcome Measures

Primary Outcome Measures

Overall Response Rate [24 months]
To determine the overall response rate according to RECIST 1.1

Secondary Outcome Measures

Progression Free Survival [6 months]
To determine six months progression free survival of patients with TET treated with selinexor
Adverse Events [24 months]
The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Rigshospitalet	Copenhagen	Denmark	2100
2	Hospices Civils de Lyon	Lyon	France
3	Intitut Curie	Paris	France
4	Intitut Gustave Roussy	Paris	France

Sponsors and Collaborators

Morten Mau-Soerensen
Institut Curie
Gustave Roussy, Cancer Campus, Grand Paris
Hospices Civils de Lyon
GSO Global Clinical Research BV
Karyopharm Therapeutics Inc

Investigators

Study Director: Morten Mau-Soerensen, MD, PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morten Mau-Soerensen, Chief Physician, MD, PhD, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT03466827

Other Study ID Numbers:

TET-SEL

First Posted:

Mar 15, 2018

Last Update Posted:

Mar 15, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thymoma

Thymus Neoplasms

Neoplasms, Glandular and Epithelial

Study Results

No Results Posted as of Mar 15, 2018