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A Study of LY3023414 in Participants With Advanced Cancer

NCT01655225 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-04-08

No results posted yet for this study

Summary

The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have.

In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.

Conditions

Interventions

DRUG

LY3023414

Administered orally. Dose of 20 to 600 mg, as determined in Part A.

DRUG

Midazolam

0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.

DRUG

Fulvestrant

500 mg administered IM on Day 1 and Day 15 in cycle 1 and Day 1 every 28 days for additional cycles.

DRUG

Pemetrexed

500 mg/m2 administered IV once on Day 1 every 21 days

DRUG

Cisplatin

75 mg/m2 administered IV once on Day 1 every 21 days

DRUG

Abemaciclib

Administered orally

DRUG

Letrozole

Administered orally

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2019-04-04
Completion
2022-02-02

Countries

  • United States
  • Italy
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655225 on ClinicalTrials.gov