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2025-08-18
2029-07
2029-07
67
NCT07026279
Amplia Therapeutics Limited
Amplia Therapeutics Limited
INTERVENTIONAL
A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer
This study is testing narmafotinib, a type of drug called a focal adhesion kinase (FAK) inhibitor, when it is given in combination with 4 chemotherapy drugs in a regimen called FOLFIRINOX, to patients who have pancreatic cancer which has metastasised (spread). The study is being run in 2 parts. Part A will test increasing dose levels of narmafotinib in at least 3 people per dose at up to 4 dose levels to assess safety. Part B will test 2 of the dose levels from Part A in 20 people per dose, to select the best dose to take forward into future studies. Participants will take narmafotinib as oral capsules every day. They will also receive mFOLFIRINOX chemotherapy on Day 1 and and Day 15 of 28-day cycles.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-04-29 | N/A | 2025-08-26 |
2025-06-10 | N/A | 2025-09-02 |
2025-06-18 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Part A 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 2 doses of narmafotinib to be explored in Part B. | DRUG: narmafotinib ascending doses
|
| EXPERIMENTAL: Part B Part B will determine the efficacy of 2 doses of narmafotinib selected from Part A | DRUG: narmafotinib dose comparison
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study | TEAEs during study treatment and follow up periods | From first dose of study drug to end of study, an expected average of 6 months |
| Part B: identification of optimal dose of narmafotinib | The optimal dose will be selected based on a review of safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and any other available relevant data | From first dose of study drug to end of study, an expected average of 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| narmafotinib levels in plasma | Measurement of maximum concentration (Cmax) of narmafotinib | Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days) |
| narmafotinib levels in plasma | Measurement of time to Cmax (tmax) of narmafotinib | Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days) |
| narmafotinib levels in plasma | Measurement of clearance of narmafotinib | Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days) |
| Overall response rate (ORR) | ORR based on RECIST 1.1 | Imaging every 56 days per participant, with an expected average duration of 6 months |
| Overall survival (OS) | OS of participants, defined as time from first dose until death from any cause | Imaging every 56 days per participant, with an expected average duration of 6 months |
| Progression free survival (PFS) | PFS of participants, defined as time from first dose to date of first observed progression, based on RECIST, or death from any cause (whichever comes first) | Imaging every 56 days per participant, with an expected average duration of 6 months |
| Clinical benefit rate (CBR) | CBR defined as the proportion of patients with complete response (CR) + partial response (PR) + stable disease (SD) with SD for at least 6 months | Imaging every 56 days per participant, with an expected average duration of 6 months |
| Duration of response (DOR) | DOR based on RECIST defined as the time from the date of the first confirmed response to the date of progression or death | Imaging every 56 days per participant, with an expected average duration of 6 months |
| Disease control rate (DCR) | DCR based on RECIST defined as the proportion of participants who achieve complete response (CR), partial response (PR) or stable disease (SD) | Imaging every 56 days per participant, with an expected average duration of 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Director, Clinical Operations Phone Number: +61 3 9123 1140 Email: info@ampliatx.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
