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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

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

NCT ID

NCT03193437

First Posted

June 19, 2017

Last Updated

February 10, 2023

Sponsor

Georgetown University

Collaborators

Hackensack Meridian Health, Karyopharm Therapeutics Inc

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

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Overall Response Rate

Description

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

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

Learn more about this trial

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

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