A Study in Myeloproliferative Disorders
The purpose of this study is to find out the safe dose range of the study drug in patients with myeloproliferative disorders.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of LY2784544 in Patients With JAK2 V617F-Positive Myeloproliferative Disorders|
- Determination of a recommended Phase 2 dosing regimen [ Time Frame: Time of first dose until last dose ] [ Designated as safety issue: Yes ]
- Number of participants with clinical significant effects [ Time Frame: Time of first dose until last dose ] [ Designated as safety issue: Yes ]
- Preliminary pharmacokinetics of LY2784544 (Cmax) [ Time Frame: Part A1: Day 1,2,15, and 29; Part A2: Day 7, 14, 21, 28, 29, 56, and 57; Part B: Day 1, 29, 57, and 113 ] [ Designated as safety issue: No ]
- Preliminary pharmacokinetics of LY2784544 (AUC) [ Time Frame: Part A1: Day 1,2,15, and 29; Part A2: Day 7, 14, 21, 28, 29, 56, and 57; Part B: Day 1, 29, 57, and 113 ] [ Designated as safety issue: No ]
- Malignant clone burden [ Time Frame: Part A1: Baseline (2 times), Weeks 13, 21 and every 6 months while patient is on study; Parts A2 and B: Baseline (2 times), Weeks 5, 8, 17, 25 and every 6 months while patient is on study ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
LY2784544 will be supplied as a capsule. The study drug will be taken by mouth daily while the patient is on study. In this study, different patients will be treated at different doses of LY2784544 until reaching the highest dose that patients can tolerate.
The purpose of the study is to learn:
- How much and how often LY2784544 should be given to patients
- What is the safety profile of LY2784544 and any side effects that might be associated with it
- How LY2784544 is taken up, distributed, broken down, and passed out of your body
- Whether LY2784544 can help patients with myeloproliferative disorders
- If any markers in the blood (biomarkers) can identify patients who will respond better to the study drug.
The planned duration of the study is not fixed. The length of time patients participate in the study will be determined by the investigator/study doctor.
Part A of the study is to determine the dose of the study drug. Part A is divided into two sections, A1 and A2. In Part A1, patients will be given study drug without a lead-in period. In Parts A2 and B, patients will have a lead-in period of 2 or 4 weeks with a low dose of LY2784544 prior to taking a higher dose of LY2784544. Part B of the study is to confirm the safety of the dose and schedule.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134120
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Director:||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|