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

NCT02014116 | Terminated Phase 1 Results

• 2 other identifiers: 13873I6X-MC-JBDA
• Study Type: interventional
• Target: 51
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Participants With Tumor Response

  Baseline through progressive disease (Up to 7.36 months)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 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

  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

  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

  Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Study Arms (9)

Cohort 1 Dose Escalation

EXPERIMENTAL

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

Cohort 2 Dose Escalation

EXPERIMENTAL

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

Cohort 3 Dose Escalation

EXPERIMENTAL

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

Cohort 4 Dose Escalation

EXPERIMENTAL

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

Cohort 5 Dose Escalation

EXPERIMENTAL

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

Cohort 6 Dose Escalation

EXPERIMENTAL

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

Cohort A Dose Confirmation

EXPERIMENTAL

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

Cohort B Dose Confirmation

EXPERIMENTAL

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

Cohort C Dose Confirmation

EXPERIMENTAL

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

Interventions

LY3009120 capsule DRUG

Administered orally.

Cohort 1 Dose Escalation; Cohort 2 Dose Escalation; Cohort 3 Dose Escalation; Cohort 4 Dose Escalation; Cohort 5 Dose Escalation; Cohort 6 Dose Escalation; Cohort A Dose Confirmation; Cohort B Dose Confirmation; Cohort C Dose Confirmation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

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, 6009, Australia

Location

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, 94805, France

Location

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, 08035, Spain

Location

MeSH Terms

Conditions

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

Interventions

LY3009120

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

This trial was terminated early based on the lack of sufficient clinical efficacy observed.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: November 26, 2013
• Primary Completion: April 7, 2017
• Study Completion: October 5, 2018
• Last Updated: December 27, 2019
• Results First Posted: December 27, 2019

Record last verified: 2019-12

Locations

FR (1); US (3); ES (1); AU (1)