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

Primary Purpose

Thymoma, Advanced Thymic Epithelial Tumor

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Open Label Selinexor
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma focused on measuring Thymus, Selinexor, KPT-330

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown Lombardi Comprehensive Cancer Center
  • John Theurer Cancer Center - Hackensack University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selinexor

Arm Description

Open Label Selinexor 40 mg

Outcomes

Primary Outcome Measures

Overall Response Rate
To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.

Secondary Outcome Measures

Overall Response Rate
To determine the overall response rate to according to modified ITMIG response criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
6 Month Progression Free Survival Rate
To determine six months progression free survival of patients with TET treated with selinexor
24 Month Overall Survival Rate
To determine overall survival of patients with TET treated with selinexor
Adverse Events
The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Full Information

First Posted
June 19, 2017
Last Updated
February 10, 2023
Sponsor
Georgetown University
Collaborators
Hackensack Meridian Health, Karyopharm Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03193437
Brief Title
Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy
Acronym
SELECT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
July 27, 2020 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
Hackensack Meridian Health, Karyopharm Therapeutics Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Advanced Thymic Epithelial Tumor
Keywords
Thymus, Selinexor, KPT-330

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selinexor
Arm Type
Experimental
Arm Description
Open Label Selinexor 40 mg
Intervention Type
Drug
Intervention Name(s)
Open Label Selinexor
Other Intervention Name(s)
KPT-330
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To determine the overall response rate to according to modified ITMIG response criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
24 months
Title
6 Month Progression Free Survival Rate
Description
To determine six months progression free survival of patients with TET treated with selinexor
Time Frame
6 months
Title
24 Month Overall Survival Rate
Description
To determine overall survival of patients with TET treated with selinexor
Time Frame
24 months
Title
Adverse Events
Description
The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul Kim, MD
Organizational Affiliation
Georgetown University
Official's Role
Study Chair
Facility Information:
Facility Name
Georgetown Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
John Theurer Cancer Center - Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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