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

NCT ID: NCT02014116

Last Updated: 2019-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-26

Study Completion Date

2018-10-05

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 Dose Escalation

LY3009120 50 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort 2 Dose Escalation

LY3009120 100 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort 3 Dose Escalation

LY3009120 200 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort 4 Dose Escalation

LY3009120 400 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort 5 Dose Escalation

LY3009120 500 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort 6 Dose Escalation

LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort A Dose Confirmation

LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort B Dose Confirmation

LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Cohort C Dose Confirmation

LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Group Type EXPERIMENTAL

LY3009120 capsule

Intervention Type DRUG

Administered orally.

Interventions

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LY3009120 capsule

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Pinnacle Oncology Hematology

Scottsdale, Arizona, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

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.

Nedlands, , Australia

Site Status

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.

Villejuif, , France

Site Status

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.

Barcelona, , Spain

Site Status

Countries

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United States Australia France Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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I6X-MC-JBDA

Identifier Type: OTHER

Identifier Source: secondary_id

13873

Identifier Type: -

Identifier Source: org_study_id