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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03193437
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Hackensack Meridian Health
Karyopharm Therapeutics Inc
Information provided by (Responsible Party):
Georgetown University

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Thymoma Advanced Thymic Epithelial Tumor Drug: Open Label Selinexor Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumor (TET) Progressing After Primary Chemotherapy (SELECT)
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Selinexor
Open Label Selinexor 40 mg
 Drug: Open Label Selinexor
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.
Other Name: KPT-330


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 24 months ]
    To determine the overall response rate according to RECIST 1.1


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 24 months ]
    To determine the overall response rate to according to modified ITMIG response criteria

  2. Progression Free Survival [ Time Frame: 6 months ]
    To determine six months progression free survival of patients with TET treated with selinexor

  3. Overall Survival [ Time Frame: 24 months ]
    To determine overall survival of patients with TET treated with selinexor

  4. Adverse Events [ Time Frame: 24 months ]
    The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed advanced TET (thymoma)
  • Progression after Primary Chemotherapy
  • No more than two previous lines (Neoadjuvant or chemoradiotherapy will count as one line if disease progression has occurred within 6 months)
  • Inoperable per local Investigator (Masaoka Stage III or IV)
  • Progression after treatment with least one platinum containing chemotherapy regimen
  • 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 or five half lives 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; Hemoglobin > 9.0 gm/dL
    • 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 7 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
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193437


Locations
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United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Jenny Crawford, RN    202-687-0893    crawfojg@georgetown.edu   
Contact: Tisdrey Torres, RN    202-687-9861    tt665@georgetown.edu   
Principal Investigator: Chul Kim, MD         
Sub-Investigator: Deepa Subramaniam, MD         
Sub-Investigator: Stephen Liu, MD         
United States, New Jersey
John Theurer Cancer Center - Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Allison Abate    551-996-8066    allison.abate@hackensackmeridian.org   
Principal Investigator: Martin E. Gutierrez, MD         
Sponsors and Collaborators
Georgetown University
Hackensack Meridian Health
Karyopharm Therapeutics Inc
Investigators
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Study Chair: Chul Kim, MD Georgetown University
More Information
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03193437    
Other Study ID Numbers: 2016-0622
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgetown University:
Thymus
Selinexor
KPT-330
Additional relevant MeSH terms:
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Thymoma
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
 Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases