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Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
Phase 1 trial testing Laboratory Biomarker Analysis in Childhood Solid Neoplasm in 30 participants. Completed in 31 March 2021.
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 27 February 2017 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 March 2021 |
| Sites | 21 locations across United States |
Children's Oncology Group — full company profile →
Adults 12 Months to 21, any sex, with Childhood Solid Neoplasm or Recurrent Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum tolerated dose or recommended phase 2 dose of prexasertib assessed by national Cancer Institute (NCI) CTCAE version 4.0 defined as the maximum dose at which fewer that one-third of patients experience a dose limiting toxicity in cycle 1
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Prexasertib) | 150 |
Number of patients with DLT to Prexasertib by dose level and study part.
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 0 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 0 | |
| Part A Dose Level 4: 150 mg/m^2 | 0 | |
| Part PK Dose Level 4: 150 mg/m^2 | 0 |
Median (min, max) area under the concentration by time curve for prexasertib assessed at 1, 1.5, 2, 4, and 8 hours on day 1 post infusion by dose level and study part
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 1718.7 | 1215.2 – 2168.6 |
| Part A Dose Level 2: 100 mg/m^2 | 2285.5 | 1658.4 – 3529.0 |
| Part A Dose Level 3: 125 mg/m^2 | 2534.4 | 2080.0 – 3535.6 |
| Part A Dose Level 4: 150 mg/m^2 | 4206.6 | 2164.9 – 5357.9 |
| Part PK Dose Level 4: 150 mg/m^2 | 3097.7 | 2443.2 – 4282.5 |
Number of response evaluable patients with response (CR/PR) using the RECIST guideline version 1.1 including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in the sum of the diameters of target lesions by dose level and study part
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 0 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 0 | |
| Part A Dose Level 4: 150 mg/m^2 | 0 | |
| Part PK Dose Level 4: 150 mg/m^2 | 0 |
Number of patients with CHK1/2 expression by percent of tumor cells with CHK1/2 expression defined by quartiles.
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 2 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 1 | |
| Part A Dose Level 4: 150 mg/m^2 | 0 | |
| Part PK Dose Level 4: 150 mg/m^2 | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 0 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 0 | |
| Part A Dose Level 4: 150 mg/m^2 | 1 | |
| Part PK Dose Level 4: 150 mg/m^2 | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 1 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 1 | |
| Part A Dose Level 4: 150 mg/m^2 | 0 | |
| Part PK Dose Level 4: 150 mg/m^2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 2 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 1 | |
| Part A Dose Level 4: 150 mg/m^2 | 1 | |
| Part PK Dose Level 4: 150 mg/m^2 | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 1 | |
| Part A Dose Level 2: 100 mg/m^2 | 1 | |
| Part A Dose Level 3: 125 mg/m^2 | 0 | |
| Part A Dose Level 4: 150 mg/m^2 | 3 | |
| Part PK Dose Level 4: 150 mg/m^2 | 0 |
Number of patients with TP53 deletion and/or mutation of Trp53 by percent of tumor cells with TP53 deletion and/or mutation of Trp53 defined by quartiles.
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 1 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 1 | |
| Part A Dose Level 4: 150 mg/m^2 | 0 | |
| Part PK Dose Level 4: 150 mg/m^2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 0 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 0 | |
| Part A Dose Level 4: 150 mg/m^2 | 2 | |
| Part PK Dose Level 4: 150 mg/m^2 | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 1 | |
| Part A Dose Level 2: 100 mg/m^2 | 1 | |
| Part A Dose Level 3: 125 mg/m^2 | 0 | |
| Part A Dose Level 4: 150 mg/m^2 | 0 | |
| Part PK Dose Level 4: 150 mg/m^2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 2 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 1 | |
| Part A Dose Level 4: 150 mg/m^2 | 1 | |
| Part PK Dose Level 4: 150 mg/m^2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Dose Level 1: 80 mg/m^2 | 2 | |
| Part A Dose Level 2: 100 mg/m^2 | 0 | |
| Part A Dose Level 3: 125 mg/m^2 | 1 | |
| Part A Dose Level 4: 150 mg/m^2 | 2 | |
| Part PK Dose Level 4: 150 mg/m^2 | 3 |
Time frame: Up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part A Dose Level 1: 80 mg… | Part A Dose Level 2: 100 m… | Part A Dose Level 3: 125 m… | Part A Dose Level 4: 150 m… | Part PK Dose Level 4: 150 … |
|---|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — | — |
| Apnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Buttock pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Catheter related infection | Infections and infestations | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — |
| Confusion | Psychiatric disorders | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Delirium | Psychiatric disorders | — | — | — | — | — |
| Depressed level of consciousness | Nervous system disorders | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — |
| Gait disturbance | General disorders | — | — | — | — | — |
| Hydrocephalus | Nervous system disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Infusion related reaction | General disorders | — | — | — | — | — |
| Lung infection | Infections and infestations | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Reaction | System | Part A Dose Level 1: 80 mg… | Part A Dose Level 2: 100 m… | Part A Dose Level 3: 125 m… | Part A Dose Level 4: 150 m… | Part PK Dose Level 4: 150 … |
|---|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — | — |
| Electrocardiogram QT corrected interval prolonged | Investigations | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Dysarthria | Nervous system disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Paresthesia | Nervous system disorders | — | — | — | — | — |
| Urinary retention | Renal and urinary disorders | — | — | — | — | — |
| Abducens nerve disorder | Nervous system disorders | — | — | — | — | — |
| Activated partial thromboplastin time prolonged | Investigations | — | — | — | — | — |
| Agitation | Psychiatric disorders | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Ataxia | Nervous system disorders | — | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — | — | — | — |
Most-reported serious reactions: Abdominal pain, Acute kidney injury, Apnea, Back pain, Buttock pain, Catheter related infection, Chills, Confusion.
Data from ClinicalTrials.gov NCT02808650 adverse events section.
This phase I trial studies the side effects and best dose of prexasertib in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1 inhibitor LY2606368 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT02808650.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing