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

Georgetown University

Status and phase

Terminated

Phase 2

Conditions

Thymoma

Advanced Thymic Epithelial Tumor

Treatments

Drug: Open Label Selinexor

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03193437

2016-0622

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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