Primary Hepatocellular CarcinomaPhase 1/2NCT00966251
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
A Phase 1/2 study testing CT-011 in people with Primary Hepatocellular Carcinoma, run by CureTech Ltd at 1 site in Israel.
Trial summary
The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hepatocellular Carcinoma
- What is being tested?
- CT-011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Jun 2011
- Phase
- Phase 1/2
- 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
- Subjects aged 18 years and above, both genders.
- Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
- No fibrolamellar subtype HCC
- Not eligible for any other systemic anti-neoplastic treatment approved for HCC
- Not eligible for Transarterial chemoembolization (TACE ).
- No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.
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- Not a candidate for curative surgical resection or liver transplantation
- Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.
- Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
- Child's Pugh classification A
- ECOG performance status 0-1
Who cannot join
- Patients progressing to liver failure.
- No core biopsy within the past 7 days
- Patients who are eligible for Transarterial Chemoembolization (TACE)
- Patients on concurrent anti-neoplastic therapy (including interferon)
- Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
- Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
- Presence of metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.
- Conditions
- Primary Hepatocellular Carcinoma
- Being tested
- CT-011
- Keywords
- Primary Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-011Drug
CT-011
| Study group | Role | What they receive |
|---|---|---|
| CT-011 | Experimental | Not described Receives: Drug: CT-011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: The study was stopped because of slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureTech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
- Investigators
- Yaron Ilan, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966251
- Sponsor's protocol ID
- CT-2009-02
- Status last verified
- Oct 2012
- First submitted
- 25 Aug 2009
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00966251
- Acronym / sponsor ID
- CT-2009-02
- Conditions
- Primary Hepatocellular Carcinoma
- Keywords
- Primary Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because of slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- CureTech LtdIndustry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Aug 2009 (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.
The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-011 | Experimental | Drug: CT-011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects aged 18 years and above, both genders.
- Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
- No fibrolamellar subtype HCC
- Not eligible for any other systemic anti-neoplastic treatment approved for HCC
- Not eligible for Transarterial chemoembolization (TACE ).
Key exclusion criteria (7 listed)
- Patients progressing to liver failure.
- No core biopsy within the past 7 days
- Patients who are eligible for Transarterial Chemoembolization (TACE)
- Patients on concurrent anti-neoplastic therapy (including interferon)
- Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
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 |
|---|---|---|
| CT-011CT-011 | Drug | CT-011 |
Primary outcome
To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The study was stopped because of slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
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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.
Yaron Ilan, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CT-011 in people with Primary Hepatocellular Carcinoma, run by CureTech Ltd at 1 site in Israel.
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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The study was stopped because of slow accrual). Results are not available in the source record.
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?
To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma (time frame: 12 months). 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 23 Oct 2012.