NL-OMON49172CompletedPhase 2
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 - PARC
Cancer Research UK Clinical Trials Unit0 sites4 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 4
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 99 (—)
Inclusion Criteria
- •Inclusion Criteria
- •* Aged 1- <25 years old at the time of study registration
- •* Histologically confirmed disease in one of the following four groups:
- •o Group 1 - Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia
- •o Group 2 - Neuroblastoma
- •o Group 3 - Sarcoma
- •o Group 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 (biopsy at
- •relapse is not mandated).
- •* Measurable bone marrow disease (group 1) or at least one evaluable
- •radiological site of disease (group 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
- •* Documented negative pregnancy test for female patients of childbearing
- •potential within 7 days of trial entry
- •* Sexually active patients must agree to use adequate and appropriate
- •contraception while on study drug and for 12 months following treatment
- •discontinuation (see section 5.3 for details)
- •* Written informed consent given by patient and/or parents/legal
- •representative*
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
Investigators
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