Data · dataset · 2015
The tumour-targeting immunocytokine F16-IL2 in combination with doxorubicin: dose escalation in patients with advanced solid tumours and expansion into patients with metastatic breast cancer
Listed in DataCite
Description
.A phase Ib/II trial was performed to evaluate safety, tolerability, recommended dose (RD) and efficacy of F16-IL2, a recombinant antibody-cytokine fusion protein, in combination with doxorubicin in patients with solid tumours (phase Ib) and metastatic breast cancer (phase II).Six patient cohorts with progressive solid tumours (n = 19) received escalating doses of F16-IL2 [5-25 Million International Units (MIU) of IL2 equivalent dose] in combination with escalating doses of doxorubicin (0-25mg/m 2 ) on day 1, 8 and 15 every 4 weeks.
Subsequently, patients with metastatic breast cancer (n = 10) received the drug combination at the RD. Clinical data and laboratory findings were analysed for safety, tolerability, and activity.F16-IL2 could be administered up to 25 MIU, in combination with the RD of doxorubicin (25mg/m 2 ). No human anti-fusion protein antibodies (HAFA) response was detected.
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Pharmacokinetics of F16-IL2 was dose-dependent over the tested range, with half-lives of ca. 13 and ca. 8 hours for cohorts dosed at lower and higher levels, respectively.Toxicities were controllable and reversible, with no combination treatment-related death. After 8 weeks, 57% and 67% disease control rates were observed for Phase I and II, respectively (decreasing to 43% and 33% after 12 weeks), considering 14 and 9 patients evaluable for efficacy.
One patient experienced a long lasting partial response (45 weeks), still on-going at exit of study.F16-IL2 can be safely and repeatedly administered at the RD of 25 Mio I.U. in combination with 25mg/m 2 doxorubicin; its safety and activity are currently being investigated in combination with other chemotherapeutics, in order to establish optimal therapy settings.
Links
Where it is published
- Repository landing page tandf.figshare.com/articles/dataset/The_tumour_targeting_immunocytokine_F16_IL2_i… ↗
landing page · from DataCite
- DOI doi.org/10.6084/m9.figshare.1285024.v1 ↗
DOI / persistent id · from DataCite
Documentation and papers
- Creative Commons Attribution 4.0 International creativecommons.org/licenses/by/4.0/legalcode ↗
license · from DataCite
- IsSupplementTo 10.4161/19336918.2014.983785 doi.org/10.4161/19336918.2014.983785 ↗
publication · from DataCite
Catalogue records · 2
- DataCite API api.datacite.org/dois/10.6084/m9.figshare.1285024.v1 ↗
metadata API · from DataCite
- DataCite Commons commons.datacite.org/doi.org/10.6084/m9.figshare.1285024.v1 ↗
catalogue entry · from DataCite
Topics
- Stated by source
- Biological sciences · Clinical medicine · Health sciences
- From keywords
- Cancer · Chemistry · Life Sciences · Medicine & Health
- Inferred from text
- Disease 75%
Related
Provenance · 1 source records, 16 field assertions
| Source | Key | Last seen | Raw |
|---|---|---|---|
| DataCite | 10.6084/m9.figshare.1285024.v1 | 13 d ago | JSON v1 |
| Field | Assertion | Extractor | Evidence |
|---|---|---|---|
| access_level | source · DataCite | connector:datacite@1.0.0 | /data/attributes/rightsList |
| byte_size | source · DataCite | connector:datacite@1.0.0 | |
| concepts[disease].local:disease:cancer | mapping · DataCite | vocabulary-mapper@1.0.0 | keywords['Cancer'] |
| concepts[disease].local:disease:disease | enrichment · DataCite | keyword-concept-rules@1.0.0 | title+description (75%) |
| concepts[field].fos:biological-sciences | source · DataCite | connector:datacite@1.0.0 | |
| concepts[field].fos:clinical-medicine | source · DataCite | connector:datacite@1.0.0 | |
| concepts[field].fos:health-sciences | source · DataCite | connector:datacite@1.0.0 | |
| concepts[field].local:field:chemistry | mapping · DataCite | vocabulary-mapper@1.0.0 | keywords['Chemistry'] |
| concepts[field].local:field:life-sciences | mapping · DataCite | vocabulary-mapper@1.0.0 | keywords['Biological Sciences'] |
| concepts[field].local:field:medicine-health | mapping · DataCite | vocabulary-mapper@1.0.0 | keywords['Medicine'] |
| created_date | source · DataCite | connector:datacite@1.0.0 | |
| description | source · DataCite | connector:datacite@1.0.0 | /data/attributes/descriptions |
| license | source · DataCite | connector:datacite@1.0.0 | /data/attributes/rightsList |
| publication_date | source · DataCite | connector:datacite@1.0.0 | /data/attributes/dates |
| title | source · DataCite | connector:datacite@1.0.0 | /data/attributes/titles/0/title |
| updated_date | source · DataCite | connector:datacite@1.0.0 |