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

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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)

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

Trial documents
2

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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