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
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
Drug | Synonyms | Arms |
---|
Open Label Selinexor | KPT-330 | Selinexor |
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
Name | Type | Description | Interventions |
---|
Selinexor | Experimental | Open Label Selinexor 40 mg | |
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
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: | Active, not recruiting |
Lead Sponsor: | Georgetown University |
Trial Keywords
Last Updated
August 13, 2021