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NCT02532010: Pacritinib

Pacritinib Combined With Decitabine or Cytarabine in Older Patients With AML

Terminated Phase 2 Results posted Last updated 15 June 2018
What this trial tests

Phase 2 trial testing Pacritinib in Acute Myeloid Leukemia (AML) in 13 participants. Terminated before completion.

Timeline
15 June 2015
Primary endpoint
9 February 2016
24 October 2017

Quick facts

Lead sponsorWeill Medical College of Cornell University
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment13
Start date15 June 2015
Primary completion9 February 2016
Estimated completion24 October 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Weill Medical College of Cornell University

Who can join

65 and older, any sex, with Acute Myeloid Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complete Remission Rate Primary · 6 months

Complete remission rate is defined as number of subjects with complete remission according to the IWG criteria, which is defined by presence of \<5 percent of blasts in the bone marrow, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.

GroupValue95% CI
Arm A: Pacritinib and Decitiabine0
Arm B: Pacritinib and Cytarabine0
Overall Survival Secondary · 2 years

Survival following treatment to the date of death

GroupValue95% CI
Arm A: Pacritinib and Decitiabine3
Arm B: Pacritinib and Cytarabine3
Overall Remission Rate Secondary · 6 months

Overall remission rate is defined as number of subjects with complete remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR) according to the IWG criteria. CRi is defined as All CR criteria except for residual neutropenia (\<1.0 x 109/L (1000/µL)) or thrombocytopenia (\<100 x 109/L (100,000/µL)), PR is defined as relevant in the setting of phase I and II clinical trials only; all hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pretr

GroupValue95% CI
Arm A: Pacritinib and Decitiabine0
Arm B: Pacritinib and Cytarabine0
Relapse-free Survival Secondary · From date of complete remission until either AML relapse or death from any cause, whichever came first, assessed throughout the study period up to 2 years

Time from complete remission documentation to either AML relapse or death from any cause.

GroupValue95% CI
Arm A: Pacritinib and DecitiabineNANA – NA
Arm B: Pacritinib and CytarabineNANA – NA
Event-free Survival Secondary · Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause, assessed throughout the study period up to 2 years

Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause

GroupValue95% CI
Arm A: Pacritinib and Decitiabine2.52 – 4
Arm B: Pacritinib and Cytarabine31 – 5
Time to Complete Response Secondary · From entry on study until complete remission, assessed throughout the study period up to 2 years

Time from entry on study until documentation of complete remission (CR)

GroupValue95% CI
Arm A: Pacritinib and DecitiabineNANA – NA
Arm B: Pacritinib and CytarabineNANA – NA
Remission Duration Secondary · time from complete remission to AML relapse, assessed throughout the study period up to 2 years.

Time from CR documentation to AML relapse

GroupValue95% CI
Arm A: Pacritinib and DecitiabineNANA – NA
Arm B: Pacritinib and CytarabineNANA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years, 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Pacritinib and Decitiabine
Serious: 9/9 (100%)
Deaths: 9/9
Arm B: Pacritinib and Cytarabine
Serious: 4/4 (100%)
Deaths: 4/4

Serious adverse events (15 terms)

ReactionSystemArm A: Pacritinib and Deci…Arm B: Pacritinib and Cyta…
neutropenic feverBlood and lymphatic system disorders
dizzinessNervous system disorders
Dizziness and right shoulder painNervous system disorders
feverGeneral disorders
presyncopeNervous system disorders
failure to thriveGeneral disorders
anxietyPsychiatric disorders
congestive heart failureCardiac disorders
cardiopulmonary arrestCardiac disorders
dehydration/diarrheaGastrointestinal disorders
chest painCardiac disorders
fallGeneral disorders
acute respiratory failureRespiratory, thoracic and mediastinal disorders
hematuriaRenal and urinary disorders
oral ulcerationGeneral disorders
Other adverse events (181 terms — click to expand)

ReactionSystemArm A: Pacritinib and Deci…Arm B: Pacritinib and Cyta…
fatigueGeneral disorders
nauseaNervous system disorders
constipationGastrointestinal disorders
insomniaPsychiatric disorders
fallGeneral disorders
coughRespiratory, thoracic and mediastinal disorders
LE edemaGeneral disorders
hypotensionVascular disorders
dizzinessNervous system disorders
vomitingGastrointestinal disorders
dry mouthGeneral disorders
chest painCardiac disorders
Febrile NeutropeniaBlood and lymphatic system disorders
ChillsGeneral disorders
postnasal dripRespiratory, thoracic and mediastinal disorders
hypoxiaRespiratory, thoracic and mediastinal disorders
anorexiaGeneral disorders
mucositisGastrointestinal disorders
HyponatremiaMetabolism and nutrition disorders
pneumoniaRespiratory, thoracic and mediastinal disorders
epistaxisRespiratory, thoracic and mediastinal disorders
anxietyNervous system disorders
maculo-papular rashSkin and subcutaneous tissue disorders
sore throatRespiratory, thoracic and mediastinal disorders
hypomagnesemiaMetabolism and nutrition disorders
dysphagiaGastrointestinal disorders
hypophosphatemiaInvestigations
hypomagnesemiaMetabolism and nutrition disorders
bacteremiaInfections and infestations
hypokalemiaMetabolism and nutrition disorders
acute kidney injuryRenal and urinary disorders
creatinine increasedInvestigations
Ejection fraction decreasedInvestigations
pleuritic painRespiratory, thoracic and mediastinal disorders
coagulpathyBlood and lymphatic system disorders
loss of appetiteGeneral disorders
hallucinationsNervous system disorders
drug rashInvestigations
urinary retentionRenal and urinary disorders
external hemorrhoidsRenal and urinary disorders

Most-reported serious reactions: neutropenic fever, dizziness, Dizziness and right shoulder pain, fever, presyncope, failure to thrive, anxiety, congestive heart failure.

Data from ClinicalTrials.gov NCT02532010 adverse events section.

Sponsor's own description

The purpose of this study is to see if a medicine called pacritinib is both safe and effective as a study intervention for patients with AML in combination with either decitabine or cytarabine. Pacritinib is an experimental drug that is being studied to treat acute myeloid leukemia (AML). Decitabine and cytarabine are both FDA approved drugs that are used in treatment of AML. Pacritinib is being tested in clinical trials and has not been submitted to the U.S. Food and Drug Administration (FDA) for approval for any indications. Pacritinib is a drug that is designed to slow down the growth of leukemic cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
    Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w
  2. The force awakens: metastatic dormant cancer cells.
    Park SY, Park SY, Nam JS. · · 2020 · cited 149× · PMID 32300189 · DOI 10.1038/s12276-020-0423-z
  3. Emerging therapies for acute myeloid leukemia.
    Saygin C, Carraway HE. · · 2017 · cited 110× · PMID 28420416 · DOI 10.1186/s13045-017-0463-6
  4. STAT3 as a mediator of oncogenic cellular metabolism: Pathogenic and therapeutic implications.
    Tošić I, Frank DA. · · 2021 · cited 100× · PMID 34731785 · DOI 10.1016/j.neo.2021.10.003
  5. Small-molecule agents for cancer immunotherapy.
    Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010
  6. JAK/STAT in leukemia: a clinical update.
    Liang D, Wang Q, Zhang W, Tang H, et al · · 2024 · cited 38× · PMID 38273387 · DOI 10.1186/s12943-023-01929-1
  7. Calming the cytokine storm of COVID-19 through inhibition of JAK2/STAT3 signaling.
    Gajjela BK, Zhou MM. · · 2022 · cited 38× · PMID 34743903 · DOI 10.1016/j.drudis.2021.10.016
  8. Molecular targeting in acute myeloid leukemia.
    Lim SH, Dubielecka PM, Raghunathan VM. · · 2017 · cited 32× · PMID 28851395 · DOI 10.1186/s12967-017-1281-x

Verify or expand the search:

Other trials of Pacritinib

Trials testing the same drug.

Other recruiting trials for Acute Myeloid Leukemia (AML)

Currently open trials in the same condition.

Other Weill Medical College of Cornell University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02532010.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing