EUCTR2017-002762-44-NL
Active, not recruiting
Phase 1
A phase I/II study evaluating the safety and activity of Pegylated recombinant human Arginase (BCT-100) in Relapsed/refractory cancers of Children and young adults - (duplicate) PARC for international XM
ConditionsRelpased/refractory paeditaric cancers:LeukaemiasSarcomaNeuroblastomaHigh grade glioma (brain cancers)MedDRA version: 21.0Level: PTClassification code 10000830Term: Acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relpased/refractory paeditaric cancers:LeukaemiasSarcomaNeuroblastomaHigh grade glioma (brain cancers)
- Sponsor
- niversity of Birmingham
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 1\- \<25 years old
- •Histologically confirmed disease in one of the following four cohorts. Patients with and without metastatic lesions are eligible.
- •oCohort 1 \- Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML)
- •oCohort 2 \- Neuroblastoma
- •oCohort 3 \- Sarcoma
- •oCohort 4 \- High grade glioma (as defined by 2016 WHO CNS classification)
- •Radiological or laboratory evidence of disease progression (during or after completion of first line treatment) or any subsequent recurrence
- •Measurable bone marrow disease (cohort 1\) or at least one evaluable radiological site of disease (cohort 2, 3 and 4\)
- •Adequate liver function defined as a total bilirubin \<1\.5x the upper limit of normal for age and ALT \<3x the upper limit of normal for age
- •Normal ECG
Exclusion Criteria
- •Previous treatment with another therapeutic arginine depleting drug (bacterial or human) or arginase inhibitor
- •Presence of any \= CTCAE grade 3 clinically significant treatment\-related toxicity from prior therapies
- •Pregnant or lactating female
- •Evidence of uncontrolled infection
Outcomes
Primary Outcomes
Not specified
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