Gastric CancerPhase 2NCT01874938
A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer
A Phase 2 study testing LY2875358 in people with Gastric Cancer, run by Eli Lilly and Company at 3 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- LY2875358
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of a histopathologically or cytologically confirmed local and/or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma which is unresectable
- Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma
- Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Have consent to provide a tissue sample for pre-screening
- Determined to be MET diagnostic positive based upon testing of a tumor sample obtained at any time before enrollment
- Have discontinued all previous treatments for cancer, including chemotherapy and radiotherapy, for at least 3 weeks before enrollment and have recovered from the acute effects of therapy
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- Have adequate organ function
- Male participants: must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 4 months following last dose of study drug or country requirements, whichever is longer
- Female participants: are women of child-bearing potential who test negative for pregnancy ≤14 days before enrollment based on a serum pregnancy test and agree to use a reliable method of birth control during the study and for 4 months following the last dose of the study drug and must also not be breastfeeding
- Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have an estimated life expectancy, in the judgment of the investigator, of at least 12 weeks
Who cannot join
- Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have previously completed or withdrawn from this study or any other study investigating LY2875358
- Have an active fungal, bacterial, and/or known viral infection
- Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction (MI) in 6 months prior to study drug administration
- Have symptomatic central nervous system (CNS) malignancy or metastasis
- Have previous or concurrent malignancies
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- Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
- Have corrected QT interval (QTc) of >470 millisecond (msec) on screening electrocardiogram (ECG)
- Have received previous treatment with any hepatocyte growth factor (HGF)/MET targeting therapeutics
- Have a history of radiation therapy involving more than 25% of the bone marrow. Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Japan2 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.
Aichi, 464-8681
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.
Osaka, 565-0871
South Korea1 site
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.
Seoul, 135 720
About this study
Official title: A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.
- Conditions
- Gastric Cancer
- Being tested
- LY2875358
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2875358Biological
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY2875358 | Experimental | LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle. Receives: Biological: LY2875358 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Rate
Measured: 8 Weeks
Secondary outcomes (7)
Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Measured: Baseline to Confirmed CR or PR (Estimated up to 4 Months)
Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR])
Measured: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Duration of Response
Measured: Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Overall Survival (OS)
Measured: Baseline to Death from Any Cause (Estimated up to 6 Months)
Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358
Measured: Baseline to Study Completion (Estimated up to 4 Months)
Pharmacokinetics (PK): Volume of distribution (V) of LY287358
Measured: Baseline to Study Completion (Estimated up to 4 Months)
PFS
Measured: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT01874938
- Sponsor's protocol ID
- 15007
- Other IDs
- I4C-JE-JTBE
- Status last verified
- Jan 2015
- First submitted
- 22 May 2013
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01874938
- Acronym / sponsor ID
- 15007
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jun 2013 (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 the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2875358 | Experimental | Biological: LY2875358LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a diagnosis of a histopathologically or cytologically confirmed local and/or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma which is unresectable
- Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma
- Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Have consent to provide a tissue sample for pre-screening
- Determined to be MET diagnostic positive based upon testing of a tumor sample obtained at any time before enrollment
Key exclusion criteria (10 listed)
- Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have previously completed or withdrawn from this study or any other study investigating LY2875358
- Have an active fungal, bacterial, and/or known viral infection
- Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction (MI) in 6 months prior to study drug administration
- Have symptomatic central nervous system (CNS) malignancy or metastasis
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 |
|---|---|---|
| LY2875358Administered IV | Biological | LY2875358 |
Primary outcome
Progression Free Survival (PFS) Rate
Time frame: 8 Weeks
7 secondary outcomes
Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Time frame: Baseline to Confirmed CR or PR (Estimated up to 4 Months)
Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR])
Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Duration of Response
Time frame: Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Overall Survival (OS)
Time frame: Baseline to Death from Any Cause (Estimated up to 6 Months)
Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358
Time frame: Baseline to Study Completion (Estimated up to 4 Months)
Pharmacokinetics (PK): Volume of distribution (V) of LY287358
Time frame: Baseline to Study Completion (Estimated up to 4 Months)
PFS
Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 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 16 Jan 2015.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2875358 in people with Gastric Cancer, run by Eli Lilly and Company at 3 sites in 2 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 11 inclusion and 10 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 16 Jan 2015. 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, South Korea. 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 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 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?
Progression Free Survival (PFS) Rate (time frame: 8 Weeks). 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 16 Jan 2015.