dc.contributor.author | Jones, RL | |
dc.contributor.author | Chawla, SP | |
dc.contributor.author | Attia, S | |
dc.contributor.author | Schöffski, P | |
dc.contributor.author | Gelderblom, H | |
dc.contributor.author | Chmielowski, B | |
dc.contributor.author | Le Cesne, A | |
dc.contributor.author | Van Tine, BA | |
dc.contributor.author | Trent, JC | |
dc.contributor.author | Patel, S | |
dc.contributor.author | Wagner, AJ | |
dc.contributor.author | Chugh, R | |
dc.contributor.author | Heyburn, JW | |
dc.contributor.author | Weil, SC | |
dc.contributor.author | Wang, W | |
dc.contributor.author | Viele, K | |
dc.contributor.author | Maki, RG | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-09-02T13:54:50Z | |
dc.date.available | 2022-09-02T13:54:50Z | |
dc.date.issued | 2019-07-15 | |
dc.identifier.citation | Cancer, 2019, 125 (14), pp. 2445 - 2454 | en_US |
dc.identifier.issn | 0008-543X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5394 | |
dc.identifier.eissn | 1097-0142 | |
dc.identifier.eissn | 1097-0142 | |
dc.identifier.doi | 10.1002/cncr.32084 | |
dc.description.abstract | BACKGROUND: Ontuxizumab, a humanized monoclonal antibody, targets endosialin (tumor endothelial marker 1 [TEM-1] or CD248), which is expressed on sarcoma cells and is believed to be involved in tumor angiogenesis. This is the first trial to evaluate ontuxizumab in patients with sarcoma. METHODS: Part 1 was an open-label, dose-finding, safety lead-in: 4, 6, or 8 mg/kg with gemcitabine and docetaxel (G/D; 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8). In part 2, patients were randomized in a double-blind fashion in 2:1 ratio to ontuxizumab (8 mg/kg) or a placebo with G/D. Randomization was stratified by 4 histological cohorts. RESULTS: In part 2 with 209 patients, no significant difference in progression-free survival between ontuxizumab plus G/D (4.3 months; 95% confidence interval [CI], 2.7-6.3 months) and the placebo plus G/D (5.6 months; 95% CI, 2.6-8.3 months) was observed (P = .67; hazard ratio [HR], 1.07; 95% CI, 0.77-1.49). Similarly, there was no significant difference in median overall survival between the 2 groups: 18.3 months for the ontuxizumab plus G/D group (95% CI, 16.2-21.1 months) and 21.1 months for the placebo plus G/D group (95% CI, 14.2 months to not reached; P = .32; HR, 1.23; 95% CI, 0.82-1.82). No significant differences between the treatment groups occurred for any efficacy parameter by sarcoma cohort. The combination of ontuxizumab plus G/D was generally well tolerated. CONCLUSIONS: Ontuxizumab plus G/D showed no enhanced activity over chemotherapy alone in soft-tissue sarcomas, whereas the safety profile of the combination was consistent with G/D alone. | |
dc.format | Print-Electronic | |
dc.format.extent | 2445 - 2454 | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | WILEY | en_US |
dc.relation.ispartof | Cancer | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.subject | MORAb-004 | |
dc.subject | endosialin | |
dc.subject | ontuxizumab | |
dc.subject | sarcomas | |
dc.subject | tumor endothelial marker 1 (TEM-1) | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Antibodies, Monoclonal, Humanized | |
dc.subject | Antigens, CD | |
dc.subject | Antigens, Neoplasm | |
dc.subject | Antimetabolites, Antineoplastic | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Biomarkers, Tumor | |
dc.subject | Cohort Studies | |
dc.subject | Deoxycytidine | |
dc.subject | Docetaxel | |
dc.subject | Double-Blind Method | |
dc.subject | Female | |
dc.subject | Humans | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Progression-Free Survival | |
dc.subject | Sarcoma | |
dc.subject | Young Adult | |
dc.title | A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2019-02-11 | |
dc.date.updated | 2022-09-02T13:54:28Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1002/cncr.32084 | en_US |
rioxxterms.licenseref.startdate | 2019-07-15 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/31034598 | |
pubs.issue | 14 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones)/Sarcoma Clinical Trials (R Jones) (hon.) | |
pubs.publication-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1002/cncr.32084 | |
pubs.volume | 125 | |
dc.contributor.icrauthor | Jones, Robin | |
icr.provenance | Deposited by Mr Arek Surman on 2022-09-02. Deposit type is initial. No. of files: 1. Files: A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel.pdf | |