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A Study of LY2835219 in Participants With Cancer

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasm; Neoplasm Metastasis

Intervention: LY2835219 (Drug); Clarithromycin (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

The purpose of this study is to assess how the body handles LY2835219 when it is given with another drug called clarithromycin. The study doctor will measure the amount of LY2835219 that is absorbed into the blood stream and the time that it takes to remove LY2835219 from the body. The safety and tolerability of these drugs will be studied. Each participant will complete 2 study periods in fixed order. After screening, Period 1 will last approximately 8 days and Period 2 will last approximately 15 days. Participants who complete Period 2 may continue to receive LY2835219 in 28-day cycles until discontinuation criteria are met.

Clinical Details

Official title: Effects of CYP3A Inhibition by Clarithromycin on the Pharmacokinetics of LY2835219 and Its Metabolites in Cancer Patients

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY2835219

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY32835219

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have histological or cytological evidence of cancer (solid tumors) that is advanced

and/or metastatic

- Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)

scale Exclusion Criteria:

- No symptomatic central nervous system (CNS) malignancy or metastasis

Locations and Contacts

Accelerated Comm. Oncology Research Network (ACORN), Memphis, Tennessee 38119, United States

The West Clinic, Memphis, Tennessee 38120, United States

Additional Information

Starting date: April 2014
Last updated: June 9, 2015

Page last updated: August 23, 2015

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