A Study of LY2875358 in Japanese Participants With Advanced Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT01602289
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lymphoma
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY2875358 — BIOLOGICAL
    Administered IV
  • Erlotinib — DRUG
    Administered orally
  • Gefitinib — DRUG
    Administered orally

Study Details

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.

Key Dates

First listed
May 18, 2012
Start date
Jun 30, 2012
Status verified
Jun 2015
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.)
  • 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.)

Primary Outcome Measure

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 ]

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