Spots Global Cancer Trial Database for ACCENT: AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer
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Trial Identification
Brief Title: ACCENT: AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer
Official Title: A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination With Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients
Study ID: NCT05355298
Study Description
Brief Summary: This is a multicentre, open label, two-part study to determine whether the focal adhesion kinase (FAK) inhibitor AMP945, when given prior to dosing with gemcitabine and nab-paclitaxel, improves response to therapy in first-line patients with unresectable or metastatic pancreatic cancer. Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each of 4 dose-level cohorts, to determine the RP2D of AMP945 to be explored in Part B. Part B will determine the efficacy of the AMP945 regimen at the RP2D, and will be run as a Simon Two-stage design; Stage 1 will enrol 26 participants. If ≤5 of the 26 participants show an objective response, then recruitment will be paused and a detailed analysis of futility will be performed. If the study is deemed futile, recruitment will cease. If the study is determined to be not futile or \>5 of the 26 participants show an objective response, recruitment will continue, and an additional 24 participants will be enrolled in Stage 2.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GenesisCare, St Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Gallipolli Medical Research Foundation, Greenslopes, Queensland, Australia
Epworth Healthcare, Box Hill, Victoria, Australia
Monash Health, Clayton, Victoria, Australia
Epworth Healthcare, Richmond, Victoria, Australia
Western Health, St Albans, Victoria, Australia
National Cancer Centre, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Severence Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Centre, Seoul, , Korea, Republic of
Contact Details
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