- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722825
Study of LY2157299 in Japanese Participants With Cancer
June 30, 2014 updated by: Eli Lilly and Company
Phase 1 Dose-Escalation Study of LY2157299 Monotherapy in Patients With Solid Tumors
The main purpose of this study is to evaluate the safety and side effects of LY2157299 in Japanese participants with advanced cancer or cancer that has spread to other parts of the body.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 104-0045
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. The participants must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors.
- Have a performance status of higher than or equal to 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate hematologic, hepatic and renal function.
- Have discontinued treatments for cancer excluding palliative treatments and recovered from the acute effects of therapy.
- Have discontinued treatment at least 28 days prior to the enrollment for an experimental agent that has not received regulatory approval for any indication.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Able to swallow tablets.
- Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete greater than or equal to 2 cycles of treatment.
- Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug.
- Females with child bearing potential: Have had a negative urine/serum pregnancy test greater than or equal to 7 days before the first dose of study drug and must also not be breastfeeding. If female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 30 days after the last administration.
Exclusion Criteria:
Have moderate or severe cardiac disease:
- Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled severe hypertension.
- Have documented major electrocardiogram abnormalities at the investigator's discretion.
- Have major abnormalities documented by echocardiography with Doppler. Clinically non-significant abnormalities are excluded from this criterion.
- Have persistently elevated brain natriuretic peptide or elevated Troponin I at screening local laboratory tests.
- Have 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 current hematological malignancies.
- Have central nervous system metastases.
Have serious preexisting medical conditions as follows;
- Presence or history of interstitial pneumonitis
- Uncontrollable severe diabetes
- Presence of serious active infection or uncontrollable chronic infection
- Presence of liver cirrhosis with Child-Pugh Stage of B or C
- Other serious conditions judged by the investigator
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies (HC Ab). Testing is not required unless circumstances warrant confirmation.
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LY2157299
80 up to 150 milligrams of LY2157299 administered orally, twice daily for 14 days, followed by 14 days with no study drug (2 weeks on/2 weeks off schedule) for at least two 28 day cycles.
Participants receiving clinical benefit may continue receiving treatment until discontinuation criterion is met.
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Administered orally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Dose-Limiting Toxicities
Time Frame: Day 1 through Day 28 of Cycle 1
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Day 1 through Day 28 of Cycle 1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
Time Frame: Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2
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Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2
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Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2157299
Time Frame: Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2
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Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2
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Number of Participants with a Tumor Response
Time Frame: Baseline to study completion estimated at 16 weeks
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Baseline to study completion estimated at 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559 ) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
November 5, 2012
First Submitted That Met QC Criteria
November 5, 2012
First Posted (Estimate)
November 7, 2012
Study Record Updates
Last Update Posted (Estimate)
July 1, 2014
Last Update Submitted That Met QC Criteria
June 30, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14854
- H9H-JE-JBAN (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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