Hepatocellular CarcinomaPhase 1NCT02240433
A Study of LY2157299 in Participants With Unresectable Hepatocellular Cancer (HCC)
A Phase 1 study testing LY2157299 and Sorafenib in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 3 sites in Japan.
Trial summary
The main purpose of this study is to evaluate safety and tolerability of LY2157299 when combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- LY2157299 and Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesJapan
- Study dates
- 12 Nov 2014to 25 Dec 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histological evidence of a diagnosis of HCC (except HCC with fibrolamellar or mixed histology) not amenable to curative surgery.
- Have Child-Pugh Class A.
- Have the presence of measurable or evaluable lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A measurable or evaluable lesion showing demonstrable progression after locoregional therapy could be also included.
- Have not received sorafenib prior to enrollment.
- Have resolution to Grade less than or equal 1 by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 of all clinically significant toxic effects of prior locoregional therapy, surgery, chemoembolization, systemic chemotherapy.
- Have a performance status of less than or equal 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Who cannot join
- Are currently enrolled, or discontinued within 28 days prior to enrollment from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have undergone major surgery within 28 days prior to enrollment.
- Have undergone hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, percutaneous ethanol injection, or percutaneous microwave coagulation therapy) within 28 days prior to enrollment.
- Have moderate or severe cardiac disease.
- Myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension.
- Documented major electrocardiogram (ECG) abnormalities at the investigator's discretion within 28 days prior to enrollment.
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- Major abnormalities documented by echocardiography with Doppler at investigator's direction within 28 days prior to enrollment.
- Have persistently elevated brain natriuretic peptide (BNP) or elevated troponin I within 14 days prior to enrollment.
- Predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress.
- Have a history of cardiac or aortic surgery.
- Have undergone liver transplant.
- Are pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country.
Japan3 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.
Chiba, 277 8577
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.
Kanagawa, 241-8515
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.
Suita-shi, 565-0871
About this study
Official title: A Phase 1b Study of LY2157299 in Combination With Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
The main purpose of this study is to evaluate safety and tolerability of LY2157299 when combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- LY2157299, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2157299Drug
LY2157299 administered orally
SorafenibDrug
Sorafenib administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY2157299 + Sorafenib | Experimental | LY2157299 will be administered orally twice daily for 14 days, followed by 14 days with no study drug per 28-day cycle. Sorafenib will be administered orally twice daily for 28 days, in each cycle. Receives: Drug: LY2157299; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)
Measured: Cycle 1 (28 days)
Secondary outcomes (5)
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve (AUC) of LY2157299
Measured: Cycle 1 Day1: predose through 6 hours post dose; Cycle1 Day14: predose through 24 hours post dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY2157299
Measured: Cycle 1 Day 1: Predose through 6 hours post dose; Cycle 1 Day 14: Predose through 24 hours post dose
Time to Progression (TTP)
Measured: Baseline to objective progressive disease (estimated as 6 months)
Progression-free Survival (PFS)
Measured: Baseline to objective progressive disease or death (estimated as 6 months)
The Number of Participants with Best Response of Partial Response (PR), Complete Response (CR), Stable Disease (SD), or Progressive Disease (PD)
Measured: Baseline to objective progressive disease (estimated as 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study start12 Nov 2014
- Primary completion19 Jul 2017
- Study completion25 Dec 2019
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240433
- Sponsor's protocol ID
- 14856
- Other IDs
- H9H-JE-JBAP
- Status last verified
- 1 Feb 2020
- First submitted
- 11 Sep 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of LY2157299 in Combination With Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02240433
- Acronym / sponsor ID
- 14856
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 15 Sep 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.
The main purpose of this study is to evaluate safety and tolerability of LY2157299 when combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2157299 + Sorafenib | Experimental | Drug: LY2157299, Drug: SorafenibLY2157299 will be administered orally twice daily for 14 days, followed by 14 days with no study drug per 28-day cycle. Sorafenib will be administered orally twice daily for 28 days, in each cycle. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have histological evidence of a diagnosis of HCC (except HCC with fibrolamellar or mixed histology) not amenable to curative surgery.
- Have Child-Pugh Class A.
- Have the presence of measurable or evaluable lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A measurable or evaluable lesion showing demonstrable progression after locoregional therapy could be also included.
- Have not received sorafenib prior to enrollment.
- Have resolution to Grade less than or equal 1 by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 of all clinically significant toxic effects of prior locoregional therapy, surgery, chemoembolization, systemic chemotherapy.
Key exclusion criteria (12 listed)
- Are currently enrolled, or discontinued within 28 days prior to enrollment from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have undergone major surgery within 28 days prior to enrollment.
- Have undergone hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, percutaneous ethanol injection, or percutaneous microwave coagulation therapy) within 28 days prior to enrollment.
- Have moderate or severe cardiac disease.
- Have undergone liver transplant.
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 |
|---|---|---|
| LY2157299LY2157299 administered orally | Drug | LY2157299 + Sorafenib |
| SorafenibSorafenib administered orally | Drug | LY2157299 + Sorafenib |
Primary outcome
Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)
Time frame: Cycle 1 (28 days)
5 secondary outcomes
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve (AUC) of LY2157299
Time frame: Cycle 1 Day1: predose through 6 hours post dose; Cycle1 Day14: predose through 24 hours post dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY2157299
Time frame: Cycle 1 Day 1: Predose through 6 hours post dose; Cycle 1 Day 14: Predose through 24 hours post dose
Time to Progression (TTP)
Time frame: Baseline to objective progressive disease (estimated as 6 months)
Progression-free Survival (PFS)
Time frame: Baseline to objective progressive disease or death (estimated as 6 months)
The Number of Participants with Best Response of Partial Response (PR), Complete Response (CR), Stable Disease (SD), or Progressive Disease (PD)
Time frame: Baseline to objective progressive disease (estimated as 6 months)
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 5 Feb 2020.
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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 from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) study director
Eli Lilly and Company
3 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 LY2157299 and Sorafenib in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 3 sites in Japan.
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 6 inclusion and 12 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 LY2157299 Dose-Limiting Toxicities (DLT) (time frame: Cycle 1 (28 days)). 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 5 Feb 2020.