SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01134120

Developed by Shray Alag, 2019.
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: Disease Primary Myelofibrosis Polycythemia Polycythemia Vera 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 12
GATA2 MPL SH2B3 PDGFRA BCR JAK2 PDGFRB ABL1 THPO CALR RUNX1 GATA1
Polycythemia
Genes 15
PKLR SH2B3 VHL JAK2 ENG EPO EPOR SLC30A10 EPAS1 EGLN1 BPGM ACVRL1 CYB5R3 FH GATA1
Thrombocytosis
Genes 25
MPL IFNGR1 CD55 JAK2 TET2 ELANE RPS19 RPSA HMGCL TMEM173 ABL1 THPO RUNX1 ZMPSTE24 LMNA SH2B3 HBB BCR ACAT1 ADA2 MTHFD1 CALR TTC37 TBC1D24 PMM2