Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy (SELECT)
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ClinicalTrials.gov Identifier: NCT03193437 |
Recruitment Status :
Recruiting
First Posted : June 20, 2017
Last Update Posted : August 5, 2020
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Selinexor
Open Label Selinexor 40 mg
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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 |
- Overall Response Rate [ Time Frame: 24 months ]To determine the overall response rate according to RECIST 1.1
- Overall Response Rate [ Time Frame: 24 months ]To determine the overall response rate to according to modified ITMIG response criteria
- Progression Free Survival [ Time Frame: 6 months ]To determine six months progression free survival of patients with TET treated with selinexor
- Overall Survival [ Time Frame: 24 months ]To determine overall survival of patients with TET treated with selinexor
- Adverse Events [ Time Frame: 24 months ]The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

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
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 |
Study Chair: | Chul Kim, MD | Georgetown University |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Thymus Selinexor KPT-330 |
Thymoma Thymus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Complex and Mixed Neoplasms by Histologic Type |
Neoplasms Thoracic Neoplasms Neoplasms by Site Lymphatic Diseases |