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

Lilly

Status and phase: Terminated; Phase 1

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

Treatments: Drug: LY3009120 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02014116

13873

I6X-MC-JBDA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 9 patient groups

Cohort 1 Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: LY3009120 capsule

Cohort 2 Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: LY3009120 capsule

Cohort 3 Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: LY3009120 capsule

Cohort 4 Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: LY3009120 capsule

Cohort 5 Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: LY3009120 capsule

Cohort 6 Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: LY3009120 capsule

Cohort A Dose Confirmation

Experimental group

Description:

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.

Treatment:

Drug: LY3009120 capsule

Cohort B Dose Confirmation

Experimental group

Description:

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.

Treatment:

Drug: LY3009120 capsule

Cohort C Dose Confirmation

Experimental group

Description:

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.

Treatment:

Drug: LY3009120 capsule