Trial · NCT02323880
Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
NCT02323880, Phase 1, Completed, Children's Oncology Group; results first posted 2024-01-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas. Trials, record NCT02323880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02323880
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
- NCT number
- NCT02323880
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 59 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
Malignant Glioma, Recurrent Brain Neoplasm, Recurrent Childhood Central Nervous System Neoplasm, Recurrent Childhood Glioblastoma, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Primary Central Nervous System Neoplasm, WHO Grade 3 Glioma
- Interventions
- Pharmacological Study, Selinexor
- First posted
- 2014-12-24
- Last updated
- 2025-01-14
- Results first posted
- 2024-01-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Dose Limiting Toxicities of Selinexor | Up to 28 days | The number of toxicity evaluable patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level. |
| Primary | Number of Adverse Events of Selinexor | Up to 6 years 11 months | The number of patients experiencing adverse events at least possibly attributable to selinexor by study part, schema, and dose level. |
| Primary | Area Under the Drug Concentration Curve of Selinexor | Up to 2 days | The median (min, max) of the area under the drug concentration curve evaluated at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose on day 1 for Selinexor by study part, schema, and dose level. |
| Secondary | Antitumor Effect of Selinexor | Up to 6 years 11 months | Number of patients with best response using RECIST 1.1 criteria of partial response (at least a 30% decrease in the sum of the diameters of target lesions) or complete response (disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm). |
| Secondary | Pharmacodynamics of Selinexor | Up to 28 days | Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose |
| Secondary | Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients | Up to 28 days | Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose |
| Secondary | Radiographic Response of Selinexor in High-grade Glioma (HGG) Patients | Up to 6 years 11 months | Number of HGG patients with radiographic response by study part, schema, and dose level. |
| Secondary | Progression-free Survival of Selinexor in Surgical High-grade Glioma (HGG) Patients | Up to 6 months | Number of surgical HGG patients with 6-month progression-free survival using the Response Evaluation Criteria in solid tumors criteria (RECIST v1.1) defining best response of progressive disease including at least 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and no prior stable disease, partial response, or complete response. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Dose Limiting Toxicities of Selinexor | Up to 28 days | Toxicity evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Adverse Events of Selinexor | Up to 6 years 11 months | Toxicity evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Area Under the Drug Concentration Curve of Selinexor | Up to 2 days | All eligible patients | h*ng/ml | MEDIAN |
| SECONDARY | Antitumor Effect of Selinexor | Up to 6 years 11 months | Responsive patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacodynamics of Selinexor | Up to 28 days | There were 0 (zero) patients from Part A: Dose Level 1 (Pre-amendment #1). Participation in the PD studies was optional. The subjects who had matched pre- and post-treatment blood samples were analyzed; not all the subjects had samples collected for PD analysis. | Ratio of XPO1 mRNA expression | MEDIAN |
| SECONDARY | Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients | Up to 28 days | high-grade glioma (HGG) patients with data available | Ratio of XPO1 mRNA expression | MEDIAN |
| SECONDARY | Radiographic Response of Selinexor in High-grade Glioma (HGG) Patients | Up to 6 years 11 months | high-grade glioma (HGG) patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival of Selinexor in Surgical High-grade Glioma (HGG) Patients | Up to 6 months | high-grade glioma (HGG) patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Dose Limiting Toxicities of Selinexor | Part A: Dose Level 1 | 0 | Participants | ||
| Number of Dose Limiting Toxicities of Selinexor | Part A: Dose Level 1 (DL 1) | 4 | Participants | ||
| Number of Dose Limiting Toxicities of Selinexor | Part A: Dose Level -1 (DL -1) | 1 | Participants | ||
| Number of Dose Limiting Toxicities of Selinexor | Part A: Weekly Dose Level 1 (WDL 1) | 2 | Participants | ||
| Number of Dose Limiting Toxicities of Selinexor | Part A: Weekly Dose Level -1 (WDL -1) | 1 | Participants | ||
| Number of Dose Limiting Toxicities of Selinexor | Part B: Weekly Dose Level -1 (WDL -1) | 0 | Participants | ||
| Number of Dose Limiting Toxicities of Selinexor | Part PK: Dose Level -1 (DL -1) | 2 | Participants | ||
| Number of Dose Limiting Toxicities of Selinexor | Part PK: Weekly Dose Level -1 (WDL -1) | 0 | Participants | ||
| Number of Adverse Events of Selinexor | Part A: Dose Level 1 | 6 | Participants | ||
| Number of Adverse Events of Selinexor | Part A: Dose Level 1 (DL 1) | 12 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Dose Level 1 | 6 | |
| Overall Study | STARTED | Part A: Dose Level 1 (DL 1) | 13 | |
| Overall Study | STARTED | Part A: Dose Level -1 (DL -1) | 6 | |
| Overall Study | STARTED | Part A: Weekly Dose Level 1 (WDL 1) | 6 | |
| Overall Study | STARTED | Part A: Weekly Dose Level -1 (WDL -1) | 6 | |
| Overall Study | STARTED | Part B: Weekly Dose Level -1 (WDL -1) | 10 | |
| Overall Study | STARTED | Part PK: Dose Level -1 (DL -1) | 6 | |
| Overall Study | STARTED | Part PK: Weekly Dose Level -1 (WDL -1) | 6 | |
| Overall Study | COMPLETED | Part A: Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Part A: Dose Level 1 (DL 1) | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,568
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Part A: Dose Level 1 | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A: Dose Level 1 (DL1)(Amendment 1) | 0 | 13 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A: Dose Level -1 (DL-1) | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A: Weekly Dose Level 1 (WDL 1) | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A: Weekly Dose Level -1 (WDL -1) | 1 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part B: Weekly Dose Level -1 (WDL -1) | 0 | 10 | |
| other | Abdominal distension | Gastrointestinal disorders | Part PK: Dose Level -1 (DL -1) | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part PK: Weekly Dose Level -1 (DL -1) | 0 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A: Dose Level 1 | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A: Dose Level 1 (DL1)(Amendment 1) | 1 | 13 |
1 to 10 of 2,568Source ClinicalTrials.gov
See all 2,568 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Dose Level 1 | 0 | 6 |
| Total, all-cause mortality | Part A: Dose Level 1 (DL1)(Amendment 1) | 1 | 13 |
| Total, all-cause mortality | Part A: Dose Level -1 (DL-1) | 0 | 6 |
| Total, all-cause mortality | Part A: Weekly Dose Level 1 (WDL 1) | 0 | 6 |
| Total, all-cause mortality | Part A: Weekly Dose Level -1 (WDL -1) | 0 | 6 |
| Total, all-cause mortality | Part B: Weekly Dose Level -1 (WDL -1) | 2 | 10 |
| Total, all-cause mortality | Part PK: Dose Level -1 (DL -1) | 0 | 6 |
| Total, all-cause mortality | Part PK: Weekly Dose Level -1 (DL -1) | 0 | 6 |
| Total, other adverse events | Part A: Dose Level 1 | 6 | 6 |
| Total, other adverse events | Part A: Dose Level 1 (DL1)(Amendment 1) | 13 | 13 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39998852 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA097452 | Pediatric Phase 1/Pilot Consortium | WEIGEL, BRENDA J. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2009 to 2018 |
Source NIH RePORTER
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/NCT02323880
GET https://conductscience.org/api/trials/v1/NCT02323880/results?page=2