Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy (NCT03193437) | Clinical Trial Compass
TerminatedPhase 2
Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy
Stopped: Slow Accrual
United States8 participantsStarted 2018-04-03
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.