The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
158
LSTA1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC
Chemotherapy drug provided as solution to be administered via IV infusion.
Chemotherapy drug provided as solution to be administered via IV infusion.
Border Medical Oncology
Albury, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Monash Medical Centre
Clayton, New South Wales, Australia
Lake Macquarie Private Hospital
Gateshead, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Newcastle Private Hospital
Newcastle, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
...and 14 more locations
Progression Free Survival
Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause
Time frame: From date of randomization to 18 months later, or death
Overall Survival
Period of time from randomization to date of death from any cause, or the date of last known follow-up alive
Time frame: From date of randomization to 18 months later, or death
Objective Tumour Response Rate
The number of participants with documented partial or complete response (PR or CR) divided by the number of participants evaluable for response as defined as per the RECIST version 1.1 criteria
Time frame: From date of randomization to 18 months later, or death
Patient-reported Outcomes
Completion of the EORTC QLQ-C30 questionnaire. 30 questions; 28 on a 1-4 scale (Higher scores indicative of poorer quality of life), 2 on a 1-7 scale (higher scores indicative of better health/quality of life).
Time frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Patient-reported Outcomes
Completion of the QLQ-PAN26 questionnaire. 26 questions on a 1-4 scale (Higher scores indicative of poorer quality of life)
Time frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Incidence of Treatment-Emergent Adverse Events (Patient Safety)
Record of all adverse events (including SAEs) that patients experience
Time frame: From date of randomization until 30 days after final treatment visit
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