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2019-09-17
2024-08-27
2024-09-24
11
NCT04021277
EXACT Therapeutics AS
EXACT Therapeutics AS
INTERVENTIONAL
PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin
Part 1: This clinical study will first test the safety and initial effect on the tumour of PS101-mediated ACT when given in combination with standard of care chemotherapy in patients with liver metastases (initially those with any solid tumors and then further in patients just with colorectal cancer [CRC]) in order to identify the recommended dose and schedule of PS101-mediated ACT that can be taken forward for further testing. Part 2: Based on the Part 1 results, another part in patients with liver metastases from CRC and pancreatic cancer (if indicated) may take place following a substantial protocol amendment. This record will focus on Part 1 of the study only and will be updated if Part 2 occurs.
The suboptimal delivery of an anticancer agent to the target cancer cells represent a significant problem in many solid tumours, as it compromises the effectiveness of established therapeutics. If the amount of drug that reached any tumour could be increased without changing the amount administered systemically, it should be possible to increase the effectiveness of the treatment without adding to systemic toxicity. PS101-mediated ACT involves the use of an experimental drug and an experimental device in patients with colon/rectal cancer that has spread to the liver and is given in combination with standard of care chemotherapy. The experimental drug, called PS101, is a liquid containing a mixture of positively and negatively charged microbubbles and microdroplets. It is injected into a vein (blood vessel) and from there follows the blood flow around the body to where the cancerous tumours are found. PS101 is given at the same time as a special type of ultrasound (performed using an ultrasound device) at the place in the liver where the cancerous tumour is found. The combination of PS101 and ultrasound is called Acoustic Cluster Therapy (ACT). PS101-mediated ACT can potentially increase the uptake of an anticancer agent over the ultrasound targeted area. The preclinical development of PS101-mediated ACT suggests that this therapy may be of meaningful benefit while significant additional toxicity is not anticipated.
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 |
|---|---|---|
2019-07-03 | N/A | 2024-10-08 |
2019-07-15 | N/A | 2024-10-10 |
2019-07-16 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Sequential
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Part 1a: ACT with chemotherapy in metastatic solid tumours 20 uL/kg or 40 uL/kg PS101 administered together with standard of care chemotherapy (FOLFOX or FOLFIRI) and ultrasound insonation over the targeted liver metastasis in patients with solid tumours | DRUG: 20 uL/kg PS101
DRUG: 40 uL/kg PS101
DEVICE: Ultrasound
|
| EXPERIMENTAL: Part 1b ACT with chemotherapy in metastatic CRC 20 uL/kg or 40 uL/kg PS101 administered together with standard of care chemotherapy (FOLFIRI) and ultrasound insonation over the targeted liver metastasis in patients with metastatic colorectal cancer | DRUG: 20 uL/kg PS101
DRUG: 40 uL/kg PS101
DEVICE: Ultrasound
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety and tolerability: DLTs (Part 1a only) | Proportion of patients with DLTs related to administration of PS101 IV bolus injection alone (without chemotherapy) or due to the addition of PS101 to FOLFOX or FOLFIRI | 4 weeks from the first ACT treatment in each patient |
| Number of patients with adverse events | Adverse events are summarised in the adverse event section. An overall summary will be presented here | From informed consent to 12 weeks from study start |
| Number of patients with adverse device effects | Number of patients with any AE related to the use of an Investigational Medical Device. | From the first PS101-mediated ACT procedure to 12 weeks from study start |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Preliminary anti-tumor activity at Week 8 | Change from baseline in maximum tumor diameter and volume in liver metastases | Baseline to Week 8 |
| Best overall response (Part 1b only) | Best overall response based on CR, PR, SD, PR according to RECIST Version 1.1 | Baseline to 24 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
