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 LY2835219Pharmacokinetics (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
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