Hepatocellular CarcinomaPhase 1NCT02101593
Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer
A Phase 1 study testing ADI-PEG 20 in people with Hepatocellular Carcinoma, run by Polaris Group at 2 sites in United States.
Trial summary
Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced Hepatocellular Carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- ADI-PEG 20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior diagnosis of HCC confirmed histologically.
- HCC tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status, and other biomarkers, to be performed retrospectively. Subjects with no tissue available would require a biopsy.
- No prior treatment with systemic chemotherapy (except as noted in exclusion criteria # 10).
- Measurable disease using RECIST 1.1 criteria (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapy such as (but not limited to) chemoembolization, embolization, cryoablation, hepatic artery therapy, percutaneous ethanol injection, radiation therapy, radiofrequency ablation or surgery 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. Local therapies including chemoembolization do not count as prior systemic therapy.
- Cirrhotic status of Child-Pugh grade A. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix B). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix C).
- Expected survival of at least 3 months.
- Age ≥ 18 years.
Who cannot join
- Candidate for potential curative therapies (i.e., resection or transplantation).
- Prior allograft transplantation including liver transplantation.
- Serious infection requiring treatment with 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.
- Pregnancy or lactation.
- Expected non-compliance.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV; Appendix D), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
- Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional therapies.
- Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: A Phase 1 Study of ADI PEG 20 Plus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced Hepatocellular Carcinoma (HCC).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- ADI-PEG 20
- Keywords
- argininosuccinate synthetase, arginine, arginine deiminase
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-PEG 20Drug
Also called arginine deiminase formulated with polyethylene glycol
| Study group | Role | What they receive |
|---|---|---|
| ADI-PEG 20 | Experimental | Not described Receives: Drug: ADI-PEG 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with sorafenib in advanced HCC
Measured: course of study - 1 year expected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ghassan Abou-Alfa, MD, Principal investigator, Memorial Sloan-Kettering Cancer Center (MSKCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101593
- Sponsor's protocol ID
- POLARIS2013-005
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2014
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of ADI PEG 20 Plus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT02101593
- Acronym / sponsor ID
- POLARIS2013-005
- Conditions
- Hepatocellular Carcinoma
- Keywords
- argininosuccinate synthetase, arginine, arginine deiminase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced Hepatocellular Carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADI-PEG 20 | Experimental | Drug: ADI-PEG 20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Prior diagnosis of HCC confirmed histologically.
- HCC tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status, and other biomarkers, to be performed retrospectively. Subjects with no tissue available would require a biopsy.
- No prior treatment with systemic chemotherapy (except as noted in exclusion criteria # 10).
- Measurable disease using RECIST 1.1 criteria (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapy such as (but not limited to) chemoembolization, embolization, cryoablation, hepatic artery therapy, percutaneous ethanol injection, radiation therapy, radiofrequency ablation or surgery 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. Local therapies including chemoembolization do not count as prior systemic therapy.
- Cirrhotic status of Child-Pugh grade A. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix B). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.
Key exclusion criteria (8 listed)
- Candidate for potential curative therapies (i.e., resection or transplantation).
- Prior allograft transplantation including liver transplantation.
- Serious infection requiring treatment with 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.
- Pregnancy or lactation.
- Expected non-compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-PEG 20Also: arginine deiminase formulated with polyethylene glycol | Drug | ADI-PEG 20 |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with sorafenib in advanced HCC
Time frame: course of study - 1 year expected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghassan Abou-Alfa, MD principal investigator
Memorial Sloan-Kettering Cancer Center (MSKCC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADI-PEG 20 in people with Hepatocellular Carcinoma, run by Polaris Group at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with sorafenib in advanced HCC (time frame: course of study - 1 year expected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.