JRCT ID: jRCT2080221810
Registered date:01/06/2012
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Solid Tumors, Lymphoma |
Date of first enrollment | 01/06/2012 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : LY2875358 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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. In Part B1, LY2875358 dosing will be at recommended dose by Part A and follow the same schedule. LY2875358 will be administered with erlotinib. In Part B2, LY2875358 dosing will be at recommended dose by Part A and follow the same schedule. LY2875358 will be administered with gefinitib. Generic name etc : Erlotinib INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 150mg erlotinib will be administered daily in Part B1. It is oral administration. Generic name etc : Gefinitib INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 250mg gefinitib will be administered daily in Part B2. It is oral administration. |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 histological or cytological diagnosis of advanced NSCLC, stage IV. Patients must be eligible for erlotinib therapy. Part B2 Have histological or cytological diagnosis of advanced NSCLC, stage IV. Patients must be eligible for gefinitib therapy. - Have adequate hematologic, hepatic and renal function. - Have a performance status of equal to or less than 2. - 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 - Have an estimated life expectancy, that will permit the participant to complete 8 weeks of treatment. |
Exclude criteria |
Related Information
Primary Sponsor | Eli Lilly Japan K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-121852 |
Contact
Public contact | |
Name | |
Address | 0120-360-605 |
Telephone | |
Affiliation | Eli Lilly Japan K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |