Clinical Trials /

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

NCT03193437

Description:

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

Related Conditions:
  • Thymic Carcinoma
  • Thymoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 2016-0622
  • NCT ID: NCT03193437

Conditions

  • Thymoma
  • Advanced Thymic Epithelial Tumor

Interventions

DrugSynonymsArms
Open Label SelinexorKPT-330Selinexor

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
SelinexorExperimentalOpen Label Selinexor 40 mg
  • Open Label Selinexor

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed advanced TET (thymoma or thymic carcinoma)

          -  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 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

               -  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 3 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

          -  Any other cancer (excluding radically operated localised squamous skin cancer) with
             clinical activity within the last 2 years

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate
Time Frame:24 months
Safety Issue:
Description:To determine the overall response rate according to RECIST 1.1

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:24 months
Safety Issue:
Description:To determine the overall response rate to according to modified ITMIG response criteria
Measure:Progression Free Survival
Time Frame:6 months
Safety Issue:
Description:To determine six months progression free survival of patients with TET treated with selinexor
Measure:Overall Survival
Time Frame:24 months
Safety Issue:
Description:To determine overall survival of patients with TET treated with selinexor
Measure:Adverse Events
Time Frame:24 months
Safety Issue:
Description:The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Georgetown University

Trial Keywords

  • Thymus
  • Selinexor
  • KPT-330

Last Updated

March 6, 2019