Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Colorectal Cancer Pancreatic Cancer | Combination Product: PS101 and Ultra Sound for escalation Combination Product: PS101 and Ultra Sound for expansion | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 37 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | PS101 injections and ultrasound insonation given at each session of chemotherapy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Trial of the Combination of PS101-Mediated Acoustic Cluster Therapy (ACT) With Chemotherapy for Treatment of Liver Metastasis In Patients With Solid Tumours With an Expansion Cohort in Metastatic Colorectal And Pancreatic Cancer |
Actual Study Start Date : | September 17, 2019 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2022 |
Arm | Intervention/treatment |
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Experimental: ACT with chemotherapy in metastatic solid tumours
Part 1: PS101 administered together with standard of care chemotherapy (FOLFOX or FOLFIRI) and US insonation over the targeted liver metastasis in patients with solid tumours
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Combination Product: PS101 and Ultra Sound for escalation
Part 1 - dose escalation: PS101 given 3 times in a day + 1 US insonation for PK assessment and then PS101 +US insonation given 3 times on each chemotherapy administration day over a period of 8 weeks
Other Name: ACT
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Experimental: ACT with chemotherapy in metastatic CRC
Part 2: PS101 administered together with standard of care chemotherapy (FOLFOX or FOLFIRI) and US insonation over the targeted liver metastasis in patients with metastatic colorectal cancer
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Combination Product: PS101 and Ultra Sound for expansion
Part 2: PS101 and US insonation given 3 times on each chemotherapy administration day over a period of 8 weeks
Other Name: ACT
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Experimental: ACT with chemotherapy in metastatic PDAC
Part 2: PS101 administered together with standard of care chemotherapy (Gemcitabine and nab-paclitaxel) and US insonation over the targeted liver metastasis in patients with metastatic Pancreatic Duct Adenocarcinoma (PDAC)
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Combination Product: PS101 and Ultra Sound for expansion
Part 2: PS101 and US insonation given 3 times on each chemotherapy administration day over a period of 8 weeks
Other Name: ACT
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Depending on the part of the study specific inclusion criteria will apply:
Adequate haematological, renal, hepatic laboratory requirements to allow treatment with selected standard of care chemotherapy
Laboratory Requirements - typically within 14 days prior to enrolment: Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤ 5 x (ULN) Aspartate aminotransferase (AST) ≤ 5 x (ULN) Serum creatinine ≤ 1.5 x ULN PT and APTT ≤ 1.25x ULN Albumin ≥ 28g/L
Exclusion Criteria:
Contact: Sarah J Arbe-Barnes, PhD | +44 203 2913032 | robert.miller@phoenixsolutions.no | |
Contact: Robert M Miller, MD | +44 203 2913032 | robert.miller@phoenixsolutions.no |
United Kingdom | |
The Royal Marsden NHS Foundation Trust | Recruiting |
Sutton, United Kingdom, SM2 5PT | |
Contact: Udai Banerji, MD +44 (0)208 661 3984 Udai.banerji@icr.ac.uk | |
Principal Investigator: Udai Banerji, MD |
Study Director: | Per Christian Sontum, PhD | Phoenix Solutions |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 3, 2019 | ||||||||
First Posted Date ICMJE | July 16, 2019 | ||||||||
Last Update Posted Date | September 16, 2020 | ||||||||
Actual Study Start Date ICMJE | September 17, 2019 | ||||||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
Effect assessed by elastography [ Time Frame: 18 months from study start ] Investigate the effects of ACT treatment on liver metastasis using ultrasound elastography
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Acoustic Cluster Therapy (ACT) With Chemotherapy in Metastatic Liver Metastases of Gastrointestinal Origin | ||||||||
Official Title ICMJE | Phase I Trial of the Combination of PS101-Mediated Acoustic Cluster Therapy (ACT) With Chemotherapy for Treatment of Liver Metastasis In Patients With Solid Tumours With an Expansion Cohort in Metastatic Colorectal And Pancreatic Cancer | ||||||||
Brief Summary | This clinical trial will first aim to test the safety of PS101-mediated Acoustic Cluster Therapy (ACT) in any patient with hepatic metastases in order to identify the recommended dose and schedule that can be taken forward in combination with standard of care chemotherapy, as well as standardising the ultrasound administration and imaging requirements. Following this an expansion part in patients with hepatic metastases from colorectal cancer will be started to test for evidence of ACT efficacy. Based on the emerging data from these patients, if indicated, a cohort of pancreatic ductal adenocarcinoma (PDAC) patients with hepatic metastases will be enrolled. | ||||||||
Detailed Description | 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. Acoustic Cluster Therapy (ACT) can potentially increase the uptake of an anticancer agent over the US 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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: PS101 injections and ultrasound insonation given at each session of chemotherapy Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
37 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2022 | ||||||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04021277 | ||||||||
Other Study ID Numbers ICMJE | PS101-01-2018 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Phoenix Solutions | ||||||||
Study Sponsor ICMJE | Phoenix Solutions | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Phoenix Solutions | ||||||||
Verification Date | September 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |