Trial · NCT04811196
A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients
NCT04811196, Phase 1, Completed, University Health Network, Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients. Trials, record NCT04811196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04811196
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients
- NCT number
- NCT04811196
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 56 participants, actual
- Lead sponsor
- University Health Network, Toronto
- Conditions
- Soft Tissue Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Leiomyosarcoma, Endometrial Stromal Sarcoma
- Interventions
- Selinexor
- First posted
- 2021-03-23
- Last updated
- 2025-05-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of toxicity and safety of Selinexor given on either a metronomic (Arm A) or split dosing (Arm B) schedule: Adverse Events | Up to 14 days after completion of study treatment | Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Analyses will be performed using descriptive statistics. |
| Primary | Recommended phase 2 dose of Selinexor given metronomically | Up to 28 days | Toxicity will be assessed using the NCI CTCAE, version 5.0. Adverse events will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. |
| Secondary | Progression-Free Survival (PFS) of metronomic Selinexor | From date of first dose of selinexor until the date of first documented progression, assessed up to 12 months. | The Kaplan-Meier product limit method will be used to estimate PFS of the median PFS and PFS rates at clinically relevant time point will be provided with the 95% CI. |
| Secondary | Objective Response Rate (ORR) of metronomic Selinexor | From date of first dose of selinexor until the date of first documented progression, assessed up to 12 months. | Defined as the proportion of patients who achieved a complete response (disappearance of all target tumors) or a partial response (PR) (≥30% decrease in the sum of longest diameters of target tumors) based on RECIST Version 1.1. The ORR, along with exact two-sided 95% confidence intervals based on binomial distribution will be reported. |
| Secondary | Clinical Benefit Rate (CBR) of metronomic Selinexor | From date of first dose of selinexor until the date of first documented progression, assessed up to 12 months. | Defined as the proportion of patients who achieved a complete response (disappearance of all target tumors) or a partial response (≥30% decrease in the sum of the longest diameters of target tumors) or stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) for greater than 16 weeks based on RECIST Version 1.1. The CBR, along with exact two-sided 95% confidence intervals based on binomial distribution will be reported. |
| Secondary | Peak Plasma Concentration (Cmax) of metronomic Selinexor | Prior to dose on day 1, and at 1, 2, 4, and 24 hours post dose of Cycle 1, and prior to dose on Day 1 of Cycle 2 (each cycle is 28 days). | Descriptive statistics will be used to summarize Selinexor concentration at each sampling time point and Cmax. Only the first 3 patients per dose level will be included for Cmax analysis. |
| Secondary | Area under the plasma concentration versus time curve (AUC) of metronomic Selinexor | Prior to dose on day 1, and at 1, 2, 4, and 24 hours post dose of Cycle 1, and prior to dose on Day 1 of Cycle 2 (each cycle is 28 days). | Descriptive statistics will be used to summarize AUC of Selinexor. Only the first 3 patients per dose level will be included for AUC analysis. |
| Secondary | Characterization of the toxicity of metronomic Selinexor | Up to 14 days after completion of study treatment | Analyses will be performed for all patients having received at least one dose of study drug. The study will use the NCI CTCAE v5.0. Serious adverse events, AEs, AEs leading to withdrawal/dose interruptions/dose modification will be summarized using descriptive statistics. |
| Secondary | Quality of life assessment using Quality of Life Questionnaire | Screening and then pre-dose Cycles 1, 6, and 12 (each cycle is 28 days). | To better define the toxicity of Selinexor, patient reported outcomes using 'European Organization for Research and Treatment of Cancer' (EORTC) 'Quality of Life Questionnaire' (QLQ-C30) will be investigated. The score ranges from 1 to 4, with 1 being the worst outcome and 4 being the best. Mean score of individual item numbers of interest will be analyzed with descriptive and mixed effect model methods. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04811196
GET https://conductscience.org/api/trials/v1/NCT04811196/registered