Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT01134120
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2010-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Myeloproliferative Disorders
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Phase 1 Study of LY2784544 in Patients With JAK2 V617F-Positive Myeloproliferative Disorders
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out the safe dose range of the study drug in patients with myeloproliferative disorders.
Detailed Description:
The purpose of the study is to learn:
1. How much and how often LY2784544 should be given to patients
2. What is the safety profile of LY2784544 and any side effects that might be associated with it
3. How LY2784544 is taken up, distributed, broken down, and passed out of your body
4. Whether LY2784544 can help patients with myeloproliferative disorders
5. 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.
1. How much and how often LY2784544 should be given to patients
2. What is the safety profile of LY2784544 and any side effects that might be associated with it
3. How LY2784544 is taken up, distributed, broken down, and passed out of your body
4. Whether LY2784544 can help patients with myeloproliferative disorders
5. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| I3X-MC-JHTA | OTHER | Eli Lilly and Company | View |