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Report for Clinical Trial NCT01134120

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1 Study of LY2784544 in Patients With JAK2 V617F-Positive Myeloproliferative Disorders

The purpose of this study is to find out the safe dose range of the study drug in patients with myeloproliferative disorders.

NCT01134120 Myeloproliferative Disorders Thrombocythemia, Essential Polycythemia Vera Primary Myelofibrosis
MeSH: Polycythemia Vera Primary Myelofibrosis Polycythemia Thrombocytosis Myeloproliferative Disorders Thrombocythemia, Essential
HPO: Myeloproliferative disorder Polycythemia Thrombocytosis

1 Interventions

Name: LY2784544

Description: 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.

Type: Drug

LY2784544


Primary Outcomes

Measure: Determination of a recommended Phase 2 dosing regimen

Time: Time of first dose until last dose

Measure: Number of participants with clinical significant effects

Time: Time of first dose until last dose

Secondary Outcomes

Measure: Preliminary pharmacokinetics of LY2784544 (Cmax)

Time: 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

Measure: Preliminary pharmacokinetics of LY2784544 (AUC)

Time: 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

Measure: Malignant clone burden

Time: 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

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V617F

A Phase 1 Study of LY2784544 in Patients With JAK2 V617F-Positive Myeloproliferative Disorders. --- V617F ---

has post-ET MF - Have a quantifiable JAK2 V617F mutation - Have discontinued all previous approved therapies for myeloproliferative disorders, including any chemotherapy, immunomodulating therapy (for example, thalidomide, interferon-alpha), immunosuppressive therapy (for example, corticosteroids greater than 10 mg/day prednisone or equivalent), radiotherapy, and erythropoietin, thrombopoietin, or granulocyte colony stimulating factor for at least 14 days and recovered from the acute effects of therapy. --- V617F ---



HPO Nodes


HPO:
Myeloproliferative disorder
Genes 14
CALR THPO PDGFRA CALR SH2B3 JAK2 GATA2 BCR ABL1 PDGFRB MPL SH2B3 GATA1 RUNX1
Polycythemia
Genes 19
EPO CCND1 ACVRL1 GATA1 VHL EPAS1 EGLN1 FH SLC30A10 SLC30A10 CYB5R3 SH2B3 PKLR JAK2 JAK2 EPOR BPGM ENG VHL
Thrombocytosis
Genes 37
TTC37 RPSA MPL THPO HMGCL SKIV2L CD55 ACAT1 TBC1D24 THPO CALR SH2B3 PMM2 TTC37 MTHFD1 ADA2 JAK2 RUNX1 TET2 LMNA JAK2 JAK2 CALR IFNGR1 ELANE MPL RPS14 SF3B1 RPS19 HBB STING1 MPL BCR TET2 JAK2 ABL1 ZMPSTE24