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

A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer

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 Overview

• Status: Terminated
• Conditions: Melanoma; Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Colorectal Neoplasms
• Intervention / Treatment: Drug: LY3009120 capsule

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Nedlands, Australia, 6009
    • 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.
• France
  • Villejuif, France, 94805
    • 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.
• Spain
  • Barcelona, Spain, 08035
    • 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.
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Pinnacle Oncology Hematology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: LY3009120 capsule; Administered orally.
Experimental: 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.	Drug: LY3009120 capsule; Administered orally.
Experimental: 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.	Drug: LY3009120 capsule; Administered orally.
Experimental: 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	Drug: LY3009120 capsule; Administered orally.
Experimental: 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	Drug: LY3009120 capsule; Administered orally.
Experimental: 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	Drug: LY3009120 capsule; Administered orally.
Experimental: 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.	Drug: LY3009120 capsule; Administered orally.
Experimental: 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.	Drug: LY3009120 capsule; Administered orally.
Experimental: 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.	Drug: LY3009120 capsule; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Cycle 1 (28 Days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.	Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28	PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.	Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1	PK: area under the concentration versus time curve [0-∞] of LY3009120 after a single oral dose Cycle 1 Day1.	Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15	PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state [AUC0-τ].	Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28	PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC[0-τ].	Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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, Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2013
• Primary Completion (Actual): April 7, 2017
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: 13873 (Other Identifier: Stanford IRB); I6X-MC-JBDA (Other Identifier: Eli Lilly and Company)