- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01602289
A Study of LY2875358 in Japanese Participants With Advanced Cancer
June 4, 2015 updated by: Eli Lilly and Company
A Phase 1 Study of LY2875358 in Japanese Patients With Advanced Malignancies
The purpose of this study is to assess the safety and tolerability of LY2875358 in Japanese participants with cancer that is advanced and/or may have spread to another part of the body.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study has 3 parts. Participants may only enroll in one part.
Part A - Participants will receive LY2875358.
Part B1 - Participants with non-small cell lung cancer (NSCLC) will receive LY2875358 and erlotinib.
Part B2 - Participants with NSCLC will receive LY2875358 and gefitinib.
Parts B1 and B2 were added per protocol amendment in January, 2013.
Study Type
Interventional
Enrollment (Actual)
17
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
-
-
-
Chiba, Japan, 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.
-
-
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:
- Part A: Have histological or cytological evidence of malignancies (solid tumor or lymphoma) that are advanced and/or metastatic. The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have been used
- Part B1: Have histologic or cytologic diagnosis of advanced NSCLC, Stage IV per the 7th edition of the American Joint Committee on Cancer (AJCC) Staging Criteria for NSCLC. The participants must have no other effective therapeutic option and be eligible for erlotinib therapy per Japanese package insert in the opinion of investigator
- Part B2: Have histologic or cytologic diagnosis of advanced NSCLC with epidermal growth factor receptor (EGFR) activating mutation, Stage IV per the 7th edition of the AJCC Staging Criteria for NSCLC. The participants must have no other effective therapeutic option and be eligible for gefitinib therapy per Japanese package insert in the opinion of investigator
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Revised Response Criteria for Malignant Lymphoma
- Have adequate hematologic, hepatic and renal function
- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half lives prior to study enrollment, whichever is shorter, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline or ≤ Grade 1). Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days
- 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 or until in the judgment of the investigator, it is safe for the participant to become pregnant
- Females with child bearing potential: Have had a negative urine pregnancy test ≤7 days before the first dose of study drug and must also not be breastfeeding. If female who stop breastfeeding enter the study, the female must stop breastfeeding from the day of the first study drug administration until 4 months after the last dose
- Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete 8 weeks of treatment
Exclusion Criteria:
- Have serious preexisting medical conditions
- Part A: Have symptomatic central nervous system malignancy or metastasis
- Part B: Have brain metastases that are symptomatic or require ongoing treatment with steroids or radiation therapy
- Have current acute or chronic leukemia (participants with adult T-cell leukemia/lymphoma are eligible)
- Have an active fungal, bacterial, and/or known viral infection
- Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
- Have a history of New York Heart Association (NYHA) class ≥3, unstable angina, myocardial infarction in 6 months prior to study drug administration
- Have QTc interval of >470 milliseconds (msec) on screening electrocardiogram
- Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
- Participants with active alcohol abuse, as determined by the treating investigator
- Previous treatment with any extracellular domain of mesenchymal-epithelial transition factor (c-MET) targeting experimental therapeutic (for example, XL184, ARQ197, or onartuzumab)
- 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
- Part B: The participants actively receiving warfarin therapy at the time of enrollment
- Part B: Concomitant treatment with the cytochrome P450 (CYP) 3A4 modulators. The participants must not have received treatment with any of these modulators within 14 days of Cycle 1 Day 1
- Part B: Have any evidence of clinically active interstitial lung disease (ILD). Asymptomatic participants with chronic, stable, radiographic changes are eligible
- Part B: Have preexisting interstitial lung disease risks as evidenced by computed tomography (CT) scan/X-ray at baseline; have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pneumonitis, or pneumoconiosis evident on an x-ray; have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
- Part B: Have previously been intolerant of therapy with erlotinib or gefitinib
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY2875358
Part A. LY2875358 will be administered intravenously (IV) at escalating doses (700 mg up to 2000 mg) on Day 1 and Day 15 of a 28-day cycle, until any discontinuation criterion is met.
|
Administered IV
|
Experimental: LY2875358+Erlotinib
Part B1.
Erlotinib will be administered orally at 150 mg dose level each day.
LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle.
(Part B1 was added per protocol amendment in January, 2013.)
|
Administered orally
|
Experimental: LY2875358+Gefitinib
Part B2.
Gefitinib will be administered orally at 250 mg dose level each day.
LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle.
(Part B2 was added per protocol amendment in January, 2013.)
|
Administered orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with one or more drug (or procedure)-related adverse events (AEs) or any serious AEs
Time Frame: Baseline up to 56 days after last dose of study drug
|
Baseline up to 56 days after last dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics (PK): Maximum concentration (Cmax) of LY2875358, erlotinib and gefitinib
Time Frame: Predose up to Cycle 6
|
Predose up to Cycle 6
|
Pharmacokinetics (PK): Area under the concentration time curve (AUC) of LY2875358, erlotinib and gefitinib
Time Frame: Predose up to Cycle 6
|
Predose up to Cycle 6
|
Number of participants with a tumor response
Time Frame: Baseline to study completion (estimated to be 5 months)
|
Baseline to study completion (estimated to be 5 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
May 15, 2012
First Submitted That Met QC Criteria
May 16, 2012
First Posted (Estimate)
May 18, 2012
Study Record Updates
Last Update Posted (Estimate)
June 8, 2015
Last Update Submitted That Met QC Criteria
June 4, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Gefitinib
Other Study ID Numbers
- 14637
- I4C-JE-JTBD (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.
Clinical Trials on Lymphoma
-
Marcela V. Maus, M.D.,Ph.D.RecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Non-Hodgkin Lymphoma | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Non-hodgkin Lymphoma | High-grade B-cell Lymphoma | Grade 3b Follicular Lymphoma | Relapsed Non-Hodgkin LymphomaUnited States
-
Novartis PharmaceuticalsBristol-Myers SquibbRecruitingNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaUnited States, Germany, Italy, Korea, Republic of, Spain, Singapore, China, Japan, Australia
-
IGM Biosciences, Inc.ADC Therapeutics S.A.Active, not recruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | DLBCLUnited States, Korea, Republic of, Spain, France, Australia, Czechia, Italy
-
Zhejiang UniversityShanghai First Song Therapeutics Co., LtdNot yet recruitingHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Gray Zone Lymphoma | NK/T Cell Lymphoma | Peripheral T Cell Lymphoma, Unspecified | Mediastinal B-Cell Diffuse Large Cell LymphomaChina
-
Massachusetts General HospitalTG TherapeuticsActive, not recruitingLymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2United States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | Adult Diffuse Large B-Cell Lymphoma | T-Cell Non-Hodgkin LymphomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Lymphoproliferative Disorder | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Grade 3 Follicular... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
SymBio PharmaceuticalsCompletedFollicular Lymphoma | Non-Hodgkin's Lymphoma | Lymphoma, Large Cell | Diffuse, Mantle Cell Lymphoma, Lymphoma | Large B-Cell, DiffuseJapan, Korea, Republic of
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Diffuse Large B-cell LymphomaUnited States
-
Novartis PharmaceuticalsCompletedDiffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular LymphomaUnited States, Belgium, Germany, France, Italy, Korea, Republic of, Spain, Turkey
Clinical Trials on LY2875358
-
Eli Lilly and CompanyCompletedGastric CancerJapan, Korea, Republic of
-
Eli Lilly and CompanyCompleted
-
Eli Lilly and CompanyCompletedRenal Cell Carcinoma | Non-Small Cell Lung Cancer | Gastric Adenocarcinoma | Advanced Cancer | Hepatocellular Cancer | Gastroesophageal Junction AdenocarcinomaUnited States
-
Eli Lilly and CompanyActive, not recruitingCarcinoma, Non-Small-Cell LungSpain, Taiwan, United Kingdom, France, Germany, Netherlands, Korea, Republic of, Italy, Denmark
-
Eli Lilly and CompanyCompletedCarcinoma, Non-Small-Cell LungUnited States, Germany, Spain, Belgium, France, United Kingdom, Netherlands, Italy, Israel, Korea, Republic of