Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
CompletedPhase 2Results postedLast updated 5 February 2025
What this trial tests
Phase 2 trial testing Laboratory Biomarker Analysis in Advanced Malignant Solid Neoplasm in 21 participants. Completed in 31 December 2024.
Adults 12 Months to 21, any sex, with Advanced Malignant Solid Neoplasm or Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response RatePrimary· From enrollment to the end of treatment, up to 2 years
A responder is defined as a patient who achieves a best response of partial response (PR) or complete response (CR) on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. 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
Group
Value
95% CI
Treatment (Selumetinib)
0
Percentage of Participants With Treatment-related Adverse Events as Accessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0Secondary· From enrollment to the end of treatment, up to 2 years
A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
Group
Value
95% CI
Treatment (Selumetinib)
90
68.3 – 98.8
Progression Free Survival (PFS)Secondary· From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 5 years
Progression free survival will be defined as time from the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause. PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Selumetinib)
15
4.0 – 34.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From enrollment to 30 days after the end of treatment, up to 2 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Selumetinib)
Serious: 12/20 (60%)
Deaths: 5/20
Serious adverse events (21 terms)
Reaction
System
Treatment (Selumetinib)
Abdominal pain
Gastrointestinal disorders
—
Disease progression
General disorders
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Thromboembolic event
Vascular disorders
—
Papilledema
Eye disorders
—
Abdominal distension
Gastrointestinal disorders
—
Ileal obstruction
Gastrointestinal disorders
—
Rectal pain
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Death NOS
General disorders
—
Infections and infestations - Other, specify
Infections and infestations
—
CPK increased
Investigations
—
Dehydration
Metabolism and nutrition disorders
—
Hyponatremia
Metabolism and nutrition disorders
—
Bone pain
Musculoskeletal and connective tissue disorders
—
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Headache
Nervous system disorders
—
Hydrocephalus
Nervous system disorders
—
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
—
Surgical and medical procedures - Other, specify
Surgical and medical procedures
—
Hematoma
Vascular disorders
—
Other adverse events (119 terms — click to expand)
This phase II Pediatric MATCH trial studies how well selumetinib sulfate works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib sulfate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 5 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03213691.