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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02014116
• Other study ID #: 13873
• Secondary ID: I6X-MC-JBDA
• Status: Terminated
• Phase: Phase 1
• Start date: November 26, 2013
• Est. completion date: October 5, 2018

Study information

• Verified date: December 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: October 5, 2018
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• LY3009120 capsule
Administered orally.

Locations

Country	Name	City	State
Australia	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
France	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
Spain	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
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Pinnacle Oncology Hematology	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-8]) of LY3009120 Cycle 1 Day 1	PK: area under the concentration versus time curve [0-8] 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
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-t]) 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-t].	Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-t]) 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-t].	Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose