Status:
TERMINATED
PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin
Lead Sponsor:
EXACT Therapeutics AS
Conditions:
Solid Tumor
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 metast...
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...
Eligibility Criteria
Inclusion
- MAIN INCLUSION CRITERIA
- Providing informed consent and able to co-operate with the study requirements.
- Diagnosis of any advanced solid tumour with liver metastases suitable for FOLFOX or FOLFIRI chemotherapy (Part 1a) / Diagnosis of any metastatic CRC with liver metastases suitable for FOLFIRI chemotherapy (Part 1b) .
- At least two distinct target liver metastases (visible on computed tomography (CT)/magnetic resonance imaging (MRI) and of a suitable size), one being suitable for ultrasound and suitably spaced apart.
- Eastern Co-operative Oncology performance status of 0 or 1 and with a predicted meaningful survival of at least 6 months.
- . Suitable laboratory test results to receive chemotherapy.
- Females who are not pregnant or lactating; males and females willing to follow contraceptive requirements.
- Able to receive CT/MRI contrast agents.
- MAIN EXCLUSION CRITERIA
- Liver metastases suitable for immediate resection (and therefore neoadjuvant therapy unnecessary) or planned to be treated with radio-frequency ablation or other local therapies.
- Liver radiotherapy in the last 2 months.
- Use of tyrosine kinase inhibitors or monoclonal antibodies that are known to target angiogenesis receptors and/or their ligands.
- Persistent, unresolved National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido) following previous treatment.
- Grade 2 or greater sensory/motor neuropathy.
- Inadequate recovery from any prior surgical procedure or major surgical procedure in the last 4 weeks
- Serious/symptomatic active infection, or infection requiring antibiotics in the last 7 days, active cholangitis, disease requiring metal biliary stent(s), HIV infection, bleeding diathesis or other medical or psychiatric condition that might interfere with the patient's participation in the trial or results.
- Hypersensitivity to any of the components of PS101 (e.g. eggs or egg products).
- Hypersensitivity to FOLFOX or FOLFIRI, or previously having to discontinue either due to adverse events.
- Participation in any other clinical trials involving therapeutic agents in the last 4 weeks.
- History of QT prolongation, clinically significant ventricular tachycardia, ventricular fibrillation, heart block, myocardial infarction within 6 months, congestive heart failure New York Heart Association Class III or IV, unstable angina or any relevant clinical history, signs or symptoms suggestive of clinically significant, uncontrolled cardiovascular or pulmonary disease.
Exclusion
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04021277
Start Date
September 17 2019
End Date
September 24 2024
Last Update
October 10 2024
Active Locations (4)
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1
Oslo University Hospital HF
Oslo, Norway
2
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, United Kingdom, CB20QQ
3
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
4
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM25PT