Maintenance With Selinexor/Placebo After Combination Chemotherapy in Endometrial Cancer [SIENDO] (SIENDO)
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|ClinicalTrials.gov Identifier: NCT03555422|
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : January 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Selinexor Drug: Placebo||Phase 3|
Expanded Access : Karyopharm Therapeutics Inc has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||double blind placebo controlled study|
|Official Title:||A Randomized, Double-Blind, Phase 3 Trial of Maintenance With Selinexor/ Placebo After Combination Chemotherapy for Patients With Advanced or Recurrent Endometrial Cancer|
|Actual Study Start Date :||January 5, 2018|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
oral selinexor 80 mg once weekly 60 mg if BMI <20 kg/m²
Placebo Comparator: Placebo
oral placebo once weekly
- Progression Free Survival (PFS) [ Time Frame: 30 months after FPI ]Compare progression free survival (PFS) of the two treatment arms as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- PFS, as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1 [ Time Frame: 30 months after FPI ]Time from randomization until documented Progression of Disease (PD) or death due to any cause, whichever occurs first. Documented PD will be based on BICR assessments.
- Disease specific survival (DSS) [ Time Frame: 30 months after FPI ]Time from randomization until date of death from endometrial cancer.
- Overall survival (OS) [ Time Frame: 30 months after FPI ]Time from randomization until date of death from any cause.
- Time to first subsequent treatment (TFST) [ Time Frame: 30 months after FPI ]Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first.
- Progression-free survival after consecutive treatment (PFS2) [ Time Frame: 30 months after FPI ]Time from randomization until the second documented disease progression or death due to any cause by any cause on any subsequent line of anticancer therapy.
- Time to Second Subsequent Treatment (TSST) [ Time Frame: 30 months after FPI ]Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first.
- Disease Control Rate (DCR) [ Time Frame: 30 months after FPI ]Best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among patients with PR as best response to prior chemotherapy.
- Health-Related Quality of Life (HR-QoL) as measured by EORTC QLQ30 [ Time Frame: 30 months after FPI ]Patient-reported outcomes will be measured by the EORTC QLQ30 questionnaire.
- Health-Related Quality of Life (HR-QoL) as measured by EORTC QLQ-EN24 [ Time Frame: 30 months after FPI ]Patient-reported outcomes will be measured by the EORTC QLQ-EN24 questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555422
|Contact: Michael Kauffman, MD, PhD||(617) firstname.lastname@example.org|
|Contact: Sharon Shacham, PhD, MBA||(617) email@example.com|
|Study Director:||Michael Kauffman, MD, PhD||Karyopharm Therapeutics Inc|