AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors

NCT00985868 | Completed Phase 1

• 5 other identifiers: CDR0000653387UKM-ICRF-CR0708-11CRUK-CR0708-11EUDRACT-2008-005542-23EU-20980
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

Brief Summary

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

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities

• Maximum-tolerated dose

Secondary Outcomes (3)

• Pharmacokinetic parameters and the correlation between them and toxicity and/or efficacy

• The magnitude and duration of biomarkers (M30 and M65 ELISA) change after AT9283 administration

• Objective tumor response according to RECIST criteria

Interventions

multikinase inhibitor AT9283 DRUG

enzyme-linked immunosorbent assay OTHER

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (5)

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Leeds General Infirmary

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Great North Children's Hospital, Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Interventions

Enzyme-Linked Immunosorbent Assay; Immunohistochemistry

Intervention Hierarchy (Ancestors)

Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunosorbent Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Study Officials

• Darren Hargrave, MD

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2009
• First Posted: September 29, 2009
• Study Start: September 1, 2009
• Primary Completion: January 25, 2016
• Study Completion: November 20, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

GB (5)