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

NCT ID: NCT03193437

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2022-01-31

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

Conditions

Thymoma; Advanced Thymic Epithelial Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selinexor

Open Label Selinexor 40 mg

Group Type: EXPERIMENTAL

Open Label Selinexor

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

KPT-330

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: collaborator

Karyopharm Therapeutics Inc

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chul Kim, MD

Role: STUDY_CHAIR

Georgetown University

Locations

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

John Theurer Cancer Center - Hackensack University Medical Center

Hackensack, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-0622

Identifier Type: -

Identifier Source: org_study_id