Hepatocellular CarcinomaPhase 1/2NCT00415155
A Study of LY2181308 in Patients With Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing LY2181308 in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 12 sites in 4 countries.
Trial summary
The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308. 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?
- LY2181308
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Aug 2008to Jan 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
- Diagnosed with hepatocellular cancer
- Discontinued all previous therapies
- At least 18 years of age
Who cannot join
- Have other treatment options that are potentially curative or effective--such as surgical resection, liver transplant or percutaneous ablation, and/or transcatheter arterial embolization.
- Transplanted liver
- HIV positive
- More than 2 previous systemic chemotherapy treatments
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States4 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albuquerque, New Mexico, 87131
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hartford, Connecticut, 06105
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, 90089
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stony Brook, New York, 11794
France3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bondy, 93143
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Clichy, 92118
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris, 75015
Germany3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Berlin, 13353
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hanover, 30625
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mannheim, 68167
Spain2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, 08036
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pamplona, 00000
About this study
Official title: An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma
The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- LY2181308
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2181308Drug
Phase 1: 250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. (dose escalation)
Phase 2: phase 1 recommended dose, maximum 750mg dose, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: LY2181308 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Determine recommended dose
Measured: every cycle
Phase 2: Time to progression
Measured: baseline to measured progressive disease
Secondary outcomes (5)
Phase 1: Safety
Measured: every cycle
Phase 2: Overall Survival
Measured: Baseline to date of death from any cause
Phase 2: Response rate
Measured: Baseline to measured PD
Phase 2: Pharmacokinetics
Measured: Cycle 1 and Cycle 2
Phase 2: Safety
Measured: every cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startAug 2008
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Why it stopped: Trial cancelled
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.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415155
- Sponsor's protocol ID
- 10460
- Other IDs
- H8Z-MC-JACS
- Status last verified
- Aug 2008
- First submitted
- 20 Dec 2006
- Last updated
- 29 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00415155
- Acronym / sponsor ID
- 10460
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial cancelled
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 22 Dec 2006 (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 primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: LY2181308 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with hepatocellular cancer
- Discontinued all previous therapies
- At least 18 years of age
Key exclusion criteria (4 listed)
- Have other treatment options that are potentially curative or effective--such as surgical resection, liver transplant or percutaneous ablation, and/or transcatheter arterial embolization.
- Transplanted liver
- HIV positive
- More than 2 previous systemic chemotherapy treatments
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 |
|---|---|---|
| LY2181308Phase 1: 250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. (dose escalation) Phase 2: phase 1 recommended dose, maximum 750mg dose, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. | Drug | A |
Primary outcome
Phase 1: Determine recommended dose
Time frame: every cycle
Phase 2: Time to progression
Time frame: baseline to measured progressive disease
5 secondary outcomes
Phase 1: Safety
Time frame: every cycle
Phase 2: Overall Survival
Time frame: Baseline to date of death from any cause
Phase 2: Response rate
Time frame: Baseline to measured PD
Phase 2: Pharmacokinetics
Time frame: Cycle 1 and Cycle 2
Phase 2: Safety
Time frame: every cycle
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2008.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LY2181308 in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 12 sites in 4 countries.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 29 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, France, Germany, Spain. 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 withdrawn before enrolling participants, so there are no results.
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?
Phase 1: Determine recommended dose (time frame: every cycle). The study lists 2 primary outcomes in all. 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 29 Aug 2008.