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

NCT03193437 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2016-0622
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Keywords

Thymus; Selinexor; KPT-330

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Response Rate

  24 months

• 6 Month Progression Free Survival Rate

  6 months

• 24 Month Overall Survival Rate

  24 months

• Adverse Events

  24 months

Study Arms (1)

Selinexor

EXPERIMENTAL

Open Label Selinexor 40 mg

Drug: Open Label Selinexor

Interventions

Open Label Selinexor 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.

Also known as: KPT-330

Selinexor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Hackensack Meridian Health: collaborator
• Karyopharm Therapeutics Inc: collaborator

Study Sites (2)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

John Theurer Cancer Center - Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Thymoma

Interventions

selinexor

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Chul Kim, MD
• Organization: Georgetown University

Chul.Kim@gunet.georgetown.edu

(202) 444-2223

Study Officials

• Chul Kim, MD

  Georgetown University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 20, 2017
• Study Start: April 3, 2018
• Primary Completion: July 27, 2020
• Study Completion: January 31, 2022
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)