Clinical trial · Interventional
AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors
A CCLG/Cancer Research UK Phase I Trial of AT9283 (a Selective Inhibitor of Aurora Kinases) Given for 72 Hours Every 21 Days Via Intravenous Infusion in Children and Adolescents With Relapsed and Refractory Solid Tumors
NCT00985868CI-TRIAL-00041997completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: AT9283 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in children and adolescents with relapsed and refractory solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| multikinase inhibitor AT9283 | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Dose-limiting toxicities
- measure
- Maximum-tolerated dose
Secondary outcomes (3)
- measure
- Pharmacokinetic parameters and the correlation between them and toxicity and/or efficacy
- measure
- The magnitude and duration of biomarkers (M30 and M65 ELISA) change after AT9283 administration
- measure
- Objective tumor response according to RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor meeting 1 of the following criteria: * Refractory to conventional treatment * Disease for which no conventional therapy exists * Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for ≥ 1 week before study entry PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-2 OR Lansky Play PS 70-100% (\> 50% is acceptable if it is due to a stable neurological deficit or CNS tumor) * Life expectancy ≥ 12 weeks * ANC ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Serum bilirubin \< 1.5 times upper limit of normal (ULN) * Creatinine kinase normal * ALT or AST \< 2.5 times ULN (≤ 5 times ULN if due to tumor) * Creatinine clearance/EDTA-measured GFR ≥ 60 mL/min * Sufficient blood volume to undergo the blood-sampling regimen specified by the protocol that, in the opinion of the investigator, will not jeopardize patient's safety * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 6 months after completion of study therapy * Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection * Not known to be serologically positive for hepatitis B or C or HIV * Fractional shortening of \> 29% on echocardiogram * LVEF ≥ 50% * No history of allergy or auto-immune disease * No congenital heart disease * No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * More than 4 weeks since prior radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, or chemotherapy (6 weeks for investigational medicinal products, 2 weeks for vincristine) * More than 3 months since prior autologous stem cell transplantation * No prior allogenic bone marrow transplantation * No prior extensive radiotherapy to \> 25% of bone marrow * No prior Aurora kinase inhibitor * No prior major thoracic or abdominal surgery from which the patient has not yet recovered * No prior or concurrent participation in another interventional clinical trial * Participation in an observational study allowed * No other concurrent anticancer therapy or investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.