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DC Field | Value | Language |
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dc.contributor.author | Dean A.P. | - |
dc.contributor.author | Price T.J. | - |
dc.contributor.author | Sjoquist K.M. | - |
dc.contributor.author | Gebski V. | - |
dc.contributor.author | Mumford J. | - |
dc.contributor.author | Day F. | - |
dc.contributor.author | Yip S. | - |
dc.contributor.author | Bradshaw N. | - |
dc.contributor.author | Jackson C.G.C.A. | - |
dc.contributor.author | Padinharakam S. | - |
dc.contributor.author | Lee B. | - |
dc.contributor.author | Burge M.E. | - |
dc.contributor.author | Tebbutt N.C. | - |
dc.contributor.author | Steer C.B. | - |
dc.contributor.author | Lomma C. | - |
dc.contributor.author | Lam L. | - |
dc.contributor.author | Lee J. | - |
dc.contributor.author | Chantrill L.A. | - |
dc.contributor.author | Harris M. | - |
dc.date.accessioned | 2025-01-06T02:50:43Z | - |
dc.date.available | 2025-01-06T02:50:43Z | - |
dc.date.copyright | 2023 | - |
dc.date.issued | 2024-11-19 | en |
dc.identifier.citation | Journal of Clinical Oncology. Conference: 2023 American Society of Clinical Oncology Annual Meeting, ASCO. Chicago, IL United States. 41(16 Supplement) (pp PS4197), 2023. Date of Publication: June 2023. | - |
dc.identifier.uri | https://repository.monashhealth.org/monashhealthjspui/handle/1/52825 | - |
dc.description.abstract | Background: LSTA1 is a novel cyclic peptide with high tumor vascular endothelium specificity that activates an endocytotic/exocytotic transport pathway on stroma and tumor. LSTA1 potentiates greater intratumoral access for co-administered or tethered anti-cancer agents, including small molecules, antibodies, and nanoparticles, leading to increased anti-neoplastic activity. Preclinical studies in solid tumor models have shown co-administrating LSTA1 is effective in augmenting the delivery and activity of multiple anti-cancer agents. LSTA1 has been evaluated in 31 patients in a Phase I study in metastatic pancreatic ductal adenocarcinoma (mPDAC) demonstrating an objective response in 59% of patients, a 79% disease control rate at 16 weeks with a median progression free survival (PFS) of ~9.9 months. No dose limiting toxicities were observed. The ASCEND study will determine whether LSTA1 when added to SOC chemotherapy is active and safe as first-line treatment of mPDAC, and whether an additional dose of LSTA1 administered approximately 4 hours after chemotherapy further improves anti-cancer activity. Method(s): ASCEND is a randomized, double-blind, placebo-controlled phase II trial evaluating the safety and efficacy of LSTA1 3.2 mg/kg in combination with standard of care chemotherapy (nab-paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on days 1, 8, and 15, every 28 days) in patients with histologically proven, previously untreated mPDAC. A total of 155 subjects will be randomized 2:1 in favor of study intervention in two cohorts and stratified by age, ECOG status, presence of liver metastasis, and study site. Patients in cohort A receive single doses of LSTA1 or placebo, and for cohort B, two doses of LSTA1 or placebo spaced 4 hours apart. Tumour assessment occurs every 8-weeks from randomization until disease progression or commencement of a new anticancer therapy. The primary endpoint is PFS. Secondary endpoints include objective tumour response safety, overall survival, and patient reported outcomes. At 14 Feb 2023, 70 participants have been enrolled from Australian sites. Sites in Ireland and New Zealand are anticipated to open this year. | - |
dc.relation.ispartof | Journal of Clinical Oncology | - |
dc.subject.mesh | antineoplastic activity | - |
dc.subject.mesh | cancer inhibition | - |
dc.subject.mesh | electrocorticography | - |
dc.subject.mesh | liver metastasis | - |
dc.subject.mesh | pancreas metastasis | - |
dc.title | ASCEND: a randomised, double-blinded, phase II study of gemcitabine and nab-paclitaxel with cend-1/lsta1 or placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma. | - |
dc.type | Conference Abstract | - |
dc.identifier.affiliation | Oncology | - |
dc.description.conferencename | 2023 American Society of Clinical Oncology Annual Meeting, ASCO | - |
dc.description.conferencelocation | Chicago, IL, United States | - |
dc.type.studyortrial | Clinical trial | - |
local.date.conferencestart | 2023-06-02 | - |
dc.identifier.institution | (Dean, Price, Sjoquist, Gebski, Mumford, Day, Yip, Bradshaw, Jackson, Padinharakam, Lee, Burge, Tebbutt, Steer, Lomma, Lam, Lee, Chantrill, Harris) St. John of God Hospital Subiaco, Subiaco, Australia; Queen Elizabeth Hospital, University of Adelaide, Adelaide, Woodville, Australia; St. George Hospital, Kogarah, Australia; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia; Australasian Gastro-Intestinal Trials Group, Sydney, NSW, Australia; Calvary Mater Newcastle, Waratah, Australia; NHMRC Clinical Trials Centre, Camperdown, Australia; University of Otago, Dunedin, New Zealand; Chevron Place, Riverside, Australia; Northern Health, Peter MacCallum Cancer Centre, Walter and Eliza Hall Institute of Medical Research, University of Melbourne, Melbourne, VIC, Australia; Royal Brisbane and Women's Hospital, Herston, Australia; Austin Health, Heidelberg, VIC, Australia; Border Medical Oncology Research Unit, East Albury, NSW, Australia; Fiona Stanley Hospital, Murdoch, Australia; NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, Australia; University of Sydney, Sydney, Australia, Camperdown, Australia; Wollongong Hospital, NSW, Wollongong NSW, NSW, Australia; Monash Health, Bentleigh East, VIC, Australia | - |
local.date.conferenceend | 2023-06-06 | - |
item.fulltext | No Fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.grantfulltext | none | - |
item.cerifentitytype | Publications | - |
item.openairetype | Conference Abstract | - |
crisitem.author.dept | Oncology | - |
Appears in Collections: | Conferences |
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