Trial · NCT04320888
Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial
NCT04320888, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial. Trials, record NCT04320888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04320888
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial
- NCT number
- NCT04320888
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Hematopoietic and Lymphatic System Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Histiocytic and Dendritic Cell Neoplasm, Recurrent Langerhans Cell Histiocytosis, Recurrent Lymphoma, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent WHO Grade 2 Glioma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Histiocytic and Dendritic Cell Neoplasm, Refractory Langerhans Cell Histiocytosis, Refractory Lymphoma, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory WHO Grade 2 Glioma, Wilms Tumor
- Interventions
- Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Radionuclide Imaging, Selpercatinib, X-Ray Imaging
- First posted
- 2020-03-25
- Last updated
- 2026-10-09
- Results first posted
- 2025-11-06
- Limitations and caveats
- This study had significant limitations as it did not reach the target number of participants.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Selpercatinib (LOXO-292) | Up to 2 years from study entry | A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system \[CNS\] tumors). |
| Secondary | Progression-free Survival (PFS) | Up to 6 months from study entry | The Kaplan-Meier method will be used to estimate the 6 month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact. |
| Secondary | Percentage of Patients Experiencing Grade 3 or 4 Adverse Events | Up to 2 years from study entry | Evaluated by Common Terminology Criteria for Adverse Events version 5. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity. |
| Other | Profiling Changes in Tumor Genomics | Up to time of disease progression or end of protocol therapy | Will explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Selpercatinib (LOXO-292) | Up to 2 years from study entry | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Up to 6 months from study entry | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Experiencing Grade 3 or 4 Adverse Events | Up to 2 years from study entry | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Profiling Changes in Tumor Genomics | Up to time of disease progression or end of protocol therapy |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Selpercatinib (LOXO-292) | Treatment (Selpercatinib) | 100 | percentage of participants | ||
| Progression-free Survival (PFS) | Treatment (Selpercatinib) | 100 | percentage of participants | ||
| Percentage of Patients Experiencing Grade 3 or 4 Adverse Events | Treatment (Selpercatinib) | 0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Selpercatinib) | 1 | |
| Overall Study | COMPLETED | Treatment (Selpercatinib) | 1 | |
| Overall Study | NOT COMPLETED | Treatment (Selpercatinib) | 0 |
Source ClinicalTrials.gov
Adverse events15
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 | Treatment (Selpercatinib) | 1 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Selpercatinib) | 1 | 1 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Selpercatinib) | 1 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Selpercatinib) | 1 | 1 | |
| other | Dry mouth | Gastrointestinal disorders | Treatment (Selpercatinib) | 1 | 1 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Selpercatinib) | 1 | 1 | |
| other | Stomach pain | Gastrointestinal disorders | Treatment (Selpercatinib) | 1 | 1 | |
| other | Fatigue | General disorders | Treatment (Selpercatinib) | 1 | 1 | |
| other | Infections and infestations - Other, specify | Infections and infestations | Treatment (Selpercatinib) | 1 | 1 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment (Selpercatinib) | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Selpercatinib) | 0 | 1 |
| Total, other adverse events | Treatment (Selpercatinib) | 1 | 1 |
| Total, serious adverse events | Treatment (Selpercatinib) | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42867148 | 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 |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
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/NCT04320888
GET https://conductscience.org/api/trials/v1/NCT04320888/registered