Table · dataset · 2026
Table_1_RETRACTED: PARC: 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.docx
Listed in figshare and Loughborough Research Repository — shown once because both records carry DOI 10.3389/fonc.2024.1296576.s001
Background<p>The survival for many children with relapsed/refractory cancers remains poor despite advances in therapies.
Description
Arginine metabolism plays a key role in the pathophysiology of a number of pediatric cancers. We report the first in child study of a recombinant human arginase, BCT-100, in children with relapsed/refractory hematological, solid or CNS cancers.</p>Procedure<p>PARC was a single arm, Phase I/II, international, open label study.
BCT-100 was given intravenously over one hour at weekly intervals. The Phase I section utilized a modified 3 + 3 design where escalation/de-escalation was based on both the safety profile and the complete depletion of arginine (defined as adequate arginine depletion; AAD <8μM arginine in the blood after 4 doses of BCT-100). The Phase II section was designed to further evaluate the clinical activity of BCT-100 at the pediatric RP2D determined in the Phase I section, by recruitment of patients with pediatric cancers into 4 individual groups.
Read the rest (2 more)
A primary evaluation of response was conducted at eight weeks with patients continuing to receive treatment until disease progression or unacceptable toxicity.</p>Results<p>49 children were recruited globally. The Phase I cohort of the trial established the Recommended Phase II Dose of 1600U/kg iv weekly in children, matching that of adults. BCT-100 was very well tolerated.
No responses defined as a CR, CRi or PR were seen in any cohort within the defined 8 week primary evaluation period. However a number of these relapsed/refractory patients experienced prolonged radiological SD.</p>Conclusion<p>Arginine depletion is a clinically safe and achievable strategy in children with cancer. The RP2D of BCT-100 in children with relapsed/refractory cancers is established at 1600U/kg intravenously weekly and can lead to sustained disease stability in this hard to treat population.</p>Clinical trial registration<p>EudraCT, 2017-002762-44; ISRCTN, 21727048; and ClinicalTrials.gov, NCT03455140.</p>
Links
Where it is published
- DOI doi.org/10.3389/fonc.2024.1296576.s001 ↗
DOI / persistent id · from figshare com
Catalogue records · 1
- OAI-PMH record api.figshare.com/v2/oai?verb=GetRecord&metadataPrefix=oai_dc&identifier=oai%3Af… ↗
metadata API · from figshare com
Topics
- From keywords
- Astronomy & Astrophysics · Cancer · Cancer · Cancer cell biology · Cancer cell biology · Cancer diagnosis · Cancer diagnosis · Cancer genetics · Cancer genetics · Chemistry · Chemistry · Chemotherapy · Chemotherapy · Computer Science & AI · Computer Science & AI · Earth & Environmental Science · Earth & Environmental Science · Economics & Finance · Economics & Finance · Engineering · Engineering · Haematological tumours · Haematological tumours · Humanities · Humanities · Life Sciences · Life Sciences · Materials Science · Mathematics & Statistics · Medicine & Health · Medicine & Health · Molecular targets · Molecular targets · Ocean & Atmospheric Science · Psychology & Behavioral Science · Radiation therapy · Radiation therapy · Social Science · Social Science · Solid tumours · Solid tumours
- Inferred from text
- Disease 75%
Provenance · 2 source records, 47 field assertions
| Source | Key | Last seen | Raw |
|---|---|---|---|
| figshare | oai:figshare.com:article/33972685 | 4 d ago | JSON v1 |
| Loughborough Research Repository | oai:figshare.com:article/33972685 | 4 d ago | JSON v1 |
| Field | Assertion | Extractor | Evidence |
|---|---|---|---|
| access_level | source · figshare com | connector:figshare_com@1.0.0 | |
| concepts[disease].local:disease:cancer | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Cancer'] |
| concepts[disease].local:disease:cancer | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Cancer'] |
| concepts[disease].local:disease:disease | enrichment · figshare com | keyword-concept-rules@1.0.0 | title+description (75%) |
| concepts[field].anzsrc:field:321101 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Cancer Cell Biology'] |
| concepts[field].anzsrc:field:321101 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Cancer Cell Biology'] |
| concepts[field].anzsrc:field:321102 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Cancer Diagnosis'] |
| concepts[field].anzsrc:field:321102 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Cancer Diagnosis'] |
| concepts[field].anzsrc:field:321103 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Cancer Genetics'] |
| concepts[field].anzsrc:field:321103 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Cancer Genetics'] |
| concepts[field].anzsrc:field:321105 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Chemotherapy'] |
| concepts[field].anzsrc:field:321105 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Chemotherapy'] |
| concepts[field].anzsrc:field:321106 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Haematological Tumours'] |
| concepts[field].anzsrc:field:321106 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Haematological Tumours'] |
| concepts[field].anzsrc:field:321108 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Molecular Targets'] |
| concepts[field].anzsrc:field:321108 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Molecular Targets'] |
| concepts[field].anzsrc:field:321110 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Radiation Therapy'] |
| concepts[field].anzsrc:field:321110 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Radiation Therapy'] |
| concepts[field].anzsrc:field:321111 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Solid Tumours'] |
| concepts[field].anzsrc:field:321111 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Solid Tumours'] |
| concepts[field].local:field:astronomy | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:chemistry | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:chemistry | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:computer-science-ai | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:computer-science-ai | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:earth-environmental | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:earth-environmental | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:economics-finance | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:economics-finance | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:engineering | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:engineering | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:humanities | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:humanities | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:life-sciences | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:life-sciences | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:materials-science | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:mathematics-statistics | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:medicine-health | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:medicine-health | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:ocean-atmospheric | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:psychology-behavioral | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:social-science | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:social-science | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| description | source · figshare com | connector:figshare_com@1.0.0 | /metadata/dc/description |
| license | source · figshare com | connector:figshare_com@1.0.0 | /metadata/dc/rights |
| publication_date | source · figshare com | connector:figshare_com@1.0.0 | |
| title | source · figshare com | connector:figshare_com@1.0.0 | /metadata/dc/title |