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

• ClinicalTrials.gov Identifier: NCT03193437
• Recruitment Status: Recruiting
• First Posted: June 20, 2017
• Last Update Posted: February 18, 2021
• Sponsor: Georgetown University
• Collaborators: Hackensack Meridian Health; Karyopharm Therapeutics Inc
• Information provided by (Responsible Party): Georgetown University

Tracking Information

• First Submitted Date: June 19, 2017
• First Posted Date: June 20, 2017
• Last Update Posted Date: February 18, 2021
• Actual Study Start Date: April 3, 2018
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 19, 2017)

Overall Response Rate [ Time Frame: 24 months ]

To determine the overall response rate according to RECIST 1.1

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 19, 2017)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy
• 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)

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Thymoma
• Advanced Thymic Epithelial Tumor

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.

Other Name: KPT-330

Study Arms

Experimental: Selinexor

Open Label Selinexor 40 mg

Intervention: Drug: Open Label Selinexor

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 19, 2017): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03193437
• Other Study ID Numbers: 2016-0622
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Georgetown University
• Study Sponsor: Georgetown University

Collaborators

• Hackensack Meridian Health
• Karyopharm Therapeutics Inc

Investigators

• Study Chair: Chul Kim, MD; Georgetown University

• PRS Account: Georgetown University
• Verification Date: January 2021