Last reviewed · How we verify
Study of MEK162 for Children With Low-Grade Gliomas
Phase 1, PHASE2 trial testing MEK162 in Low-Grade Gliomas in 105 participants. Completed in 1 August 2025.
| Lead sponsor | Children's Hospital Los Angeles |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 4 May 2016 |
| Primary completion | 2 November 2022 |
| Estimated completion | 1 August 2025 |
| Sites | 15 locations across United States |
Children's Hospital Los Angeles
Adults 1 to 18, any sex, with Low-Grade Gliomas or Malignant Neoplasms, Brain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
For each stratum, the percentage of patients achieving at least a minor response (defined as greater than or equal to 25% decrease in maximal two dimensional measurements compared to baseline) during the first 12 cycles (nominally 48 weeks) of treatment will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Stratum 1 | 15 | |
| Phase II Stratum 2 | 12 |
Progression free and overall survival will be reported as Kaplan-Meier estimate who are alive without disease progression, alive with disease progression, deceased without disease progression, and deceased with disease progression 12 cycles (48 weeks) after treatment initiation.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Stratum 1 | 59.1 | 37.1 – 75.7 |
| Phase II Stratum 2 | 90.0 | 65.6 – 97.4 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II Stratum 1 | 95.8 | 73.9 – 99.4 |
| Phase II Stratum 2 | 100 | NA – NA |
Time frame: From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase I Dose Level 1 | Phase I Dose Level 2 | Phase I Dose Level 3 | Phase I Dose Level 4 | Phase I Dose Level 5 | Phase II Stratum 1 | Phase II Stratum 2 | Phase II Stratum 3 | Phase II Stratum 4 (Surgic… |
|---|---|---|---|---|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Lung infection | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — | — | — | — | — |
| Flu like symptoms | General disorders | — | — | — | — | — | — | — | — | — |
| Gait disturbance | General disorders | — | — | — | — | — | — | — | — | — |
| Pain | General disorders | — | — | — | — | — | — | — | — | — |
| Skin infection | Infections and infestations | — | — | — | — | — | — | — | — | — |
| CPK increased | Investigations | — | — | — | — | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Hydrocephalus | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — | — | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Dental caries | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Edema face | General disorders | — | — | — | — | — | — | — | — | — |
| Edema limbs | General disorders | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — |
| Reaction | System | Phase I Dose Level 1 | Phase I Dose Level 2 | Phase I Dose Level 3 | Phase I Dose Level 4 | Phase I Dose Level 5 | Phase II Stratum 1 | Phase II Stratum 2 | Phase II Stratum 3 | Phase II Stratum 4 (Surgic… |
|---|---|---|---|---|---|---|---|---|---|---|
| CPK increased | Investigations | — | — | — | — | — | — | — | — | — |
| Weight gain | Investigations | — | — | — | — | — | — | — | — | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Edema limbs | General disorders | — | — | — | — | — | — | — | — | — |
| Paronychia | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — |
| Left ventricular systolic dysfunction | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Optic nerve disorder | Eye disorders | — | — | — | — | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Edema trunk | General disorders | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — | — | — | — | — |
| Flu like symptoms | General disorders | — | — | — | — | — | — | — | — | — |
| Irritability | General disorders | — | — | — | — | — | — | — | — | — |
| Papulopustular rash | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Peritoneal infection | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Pharyngitis | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Rash pustular | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Pharyngeal anastomotic leak | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — |
| Wound dehiscence | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — |
| Activated partial thromboplastin time prolonged | Investigations | — | — | — | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — | — | — | — | — | — |
| Ejection fraction decreased | Investigations | — | — | — | — | — | — | — | — | — |
| Investigations - Other, specify | Investigations | — | — | — | — | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Vomiting, Lung infection, Generalized muscle weakness, Gastrointestinal disorders - Other, specify, Fever, Flu like symptoms, Gait disturbance, Pain.
Data from ClinicalTrials.gov NCT02285439 adverse events section.
The goal of this clinical trial is to study the drug MEK162 in children with a brain tumor call low-grade glioma, as well as in children with other tumors in which a specific growth signal is abnormally turned on. The main questions it aims to answer are: What is the correct dose of MEK162 in children? What are the side effects of MEK162 in children? Is MEK162 effective in children with low-grade glioma? Participants on the study receive MEK162 by mouth twice daily for up to 2 years.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Trials by the same sponsor.
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/NCT02285439.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing