A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body

Phase 1TerminatedNCT02014116

Eli Lilly and Company51 enrolled

Overview

The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms Neoplasm Metastasis Melanoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms

Interventions

LY3009120 capsuleDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Advanced or metastatic cancer * Other available therapies have failed to cure the cancer * The cancer that has no proven effective therapy * The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) * Able to swallow capsules Exclusion Criteria: * Have active cancer in the brain or spinal cord * Have an active infection of any kind (fungal, viral, or bacterial) * Have a cancer of the blood * Are pregnant or breastfeeding * Have some types of eye problems or impairments

Locations (6)

Pinnacle Oncology Hematology

Scottsdale, Arizona, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD) of LY3009120

Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.

Time frame: Cycle 1 (28 Days)

Secondary Outcomes

Number of Participants With Tumor Response

Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

Time frame: Baseline through progressive disease (Up to 7.36 months)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1

PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.

Time frame: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose

Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15

Data from ClinicalTrials.gov

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