Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorPolaris Group
About this trial
Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
Eligibility criteria
Qualifiers
Prior diagnosis of HCC confirmed by radiology, histology, or cytology.
Prior treatment with at least 1 systemic agent for Child-Pugh A subjects. However, Child-Pugh B7 subjects without prior systemic treatment may be enrolled, if they are not eligible for any approved systemic therapies (e.g., due to financial factors).
Plasma arginine ≥ 78 μM at pre-screening visit.
Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapies are eligible, provided that they have either a target lesion which has not been treated with local therapy and/or the target lesion(s) within the field of the local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan.
Disqualifiers
Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs.
Prior allograft transplantation including liver transplantation.
Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia.
Serious infection requiring treatment with intravenous, systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
Trial design
Treatments tested in this trial
- ADI-PEG20
- Placebo
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov