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

Thymoma Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03193437
• Other study ID #: 2016-0622
• Status: Terminated
• Phase: Phase 2
• Start date: April 3, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 31, 2022
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Thymic Epithelial Tumor
• Neoplasms, Glandular and Epithelial
• Thymoma
• Thymus Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	John Theurer Cancer Center - Hackensack University Medical Center	Hackensack	New Jersey
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	Hackensack Meridian Health, Karyopharm Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

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