Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma
NCT ID: NCT03466827
Last Updated: 2018-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2017-10-12
2020-07-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Selinexor
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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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
Morten Mau-Soerensen
OTHER
Responsible Party
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Morten Mau-Soerensen
Chief Physician, MD, PhD
Principal Investigators
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Morten Mau-Soerensen, MD, PhD
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Hospices Civils de Lyon
Lyon, , France
Intitut Curie
Paris, , France
Intitut Gustave Roussy
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TET-SEL
Identifier Type: -
Identifier Source: org_study_id
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