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

A Phase 2, Open-label Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumor (TET) Progressing After Primary Chemotherapy (SELECT)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03193437

Acronym

SELECT

Enrollment

Registered

2017-06-20

Start date

2018-04-03

Completion date

2022-01-31

Last updated

2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Thymic Epithelial Tumor, Thymoma

Keywords

Thymus, Selinexor, KPT-330

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

Interventions

DRUGOpen 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Response Rate	24 months	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

Measure	Time frame	Description
Overall Response Rate	24 months	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	6 months	To determine six months progression free survival of patients with TET treated with selinexor
24 Month Overall Survival Rate	24 months	To determine overall survival of patients with TET treated with selinexor
Adverse Events	24 months	The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Countries

United States

Participant flow

Participants by arm

Arm	Count
Selinexor Open Label Selinexor 40 mg 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.	8
Total	8

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	4
Overall Study	Disease Progression	2
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Selinexor
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	2 Participants
Age, Categorical Between 18 and 65 years	6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	5 Participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 8
other Total, other adverse events	8 / 8
serious Total, serious adverse events	5 / 8

Arm	Measure	Value (NUMBER)
Selinexor	Overall Response Rate	0 percent of participants

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026