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NCT02277093

Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer

Terminated Phase 2 Results posted Last updated 1 May 2017
What this trial tests

Phase 2 trial testing Pacritinib in Colorectal Cancer in 11 participants. Terminated before completion.

Timeline
22 September 2015
Primary endpoint
31 March 2016
27 October 2016

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment11
Start date22 September 2015
Primary completion31 March 2016
Estimated completion27 October 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Colorectal Cancer. 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.

Progression-free Survival (PFS) Primary · Through completion of follow-up (median follow-up was 6.61 months)

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression - at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing no

GroupValue95% CI
Pacritinib1.911.81 – 8.75
Toxicity Profile and Tolerability as Measured by Reportable Adverse Events Secondary · Up to 28 days following last day of study treatment

* The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. * Reportable adverse events will be tracked for 28 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events that are greater than or equal to grade 2 and are considered possibly, probably, or definitely related to study treatment.

Diarrhea
GroupValue95% CI
Pacritinib1
Edema limbs
GroupValue95% CI
Pacritinib1
Edema face
GroupValue95% CI
Pacritinib1
Fatigue
GroupValue95% CI
Pacritinib1
Localized edema
GroupValue95% CI
Pacritinib1
Blood bilirubin increased
GroupValue95% CI
Pacritinib1
Dyspnea
GroupValue95% CI
Pacritinib1
Rash maculopapular
GroupValue95% CI
Pacritinib1
Overall Response Rate (ORR) Secondary · Through completion of follow-up (median follow-up was 6.61 months)

* The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. * Using RECIST 1.1 * The follow-up time was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016.

GroupValue95% CI
Pacritinib0
Pacritinib0
Pacritinib1
Pacritinib6
Time to Progression (TTP) Secondary · Through completion of follow-up (median follow-up was 6.61 months)
GroupValue95% CI
Pacritinib1.73± 0.26
Overall Survival (OS) Secondary · Through completion of follow-up (median follow-up was 6.61 months)

-The follow-up time for OS was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016.

GroupValue95% CI
Pacritinib6.612.79 – 9.34

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pacritinib
Serious: 4/11 (36%)
Deaths:

Serious adverse events (5 terms)

ReactionSystemPacritinib
Alkaline phosphatase increasedInvestigations
Pleural effusionRespiratory, thoracic and mediastinal disorders
AnemiaBlood and lymphatic system disorders
Platelet count decreasedInvestigations
NauseaGastrointestinal disorders
Other adverse events (37 terms — click to expand)

ReactionSystemPacritinib
NauseaGastrointestinal disorders
ConstipationGastrointestinal disorders
FatigueGeneral disorders
AnorexiaMetabolism and nutrition disorders
InsomniaPsychiatric disorders
Abdominal painGastrointestinal disorders
Mucositis oralGastrointestinal disorders
Abdominal crampsGastrointestinal disorders
Edema limbsGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders
Abdominal distensionGastrointestinal disorders
DiarrheaGastrointestinal disorders
DyspepsiaGastrointestinal disorders
FlatulenceGastrointestinal disorders
Rectal painGastrointestinal disorders
Stomach painGastrointestinal disorders
VomitingGastrointestinal disorders
ChillsGeneral disorders
Edema faceGeneral disorders
Localized edemaGeneral disorders
Anorectal infectionInfections and infestations
Blood bilirubin increasedInvestigations
HyperglycemiaMetabolism and nutrition disorders
Flank painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
DysgeusiaNervous system disorders
HeadacheNervous system disorders
Peripheral motor neuropathyNervous system disorders
HiccupsRespiratory, thoracic and mediastinal disorders
HoarsenessRespiratory, thoracic and mediastinal disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders
Rash maculopapularSkin and subcutaneous tissue disorders
SweatingSkin and subcutaneous tissue disorders

Most-reported serious reactions: Alkaline phosphatase increased, Pleural effusion, Anemia, Platelet count decreased, Nausea.

Data from ClinicalTrials.gov NCT02277093 adverse events section.

Sponsor's own description

The investigators propose to assess the efficacy, progression-free survival, and adverse events of pacritinib in patients with refractory colorectal cancer.

Publications & conference data

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

  1. 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
  2. 2017 update on the relationship between diabetes and colorectal cancer: epidemiology, potential molecular mechanisms and therapeutic implications.
    González N, Prieto I, Del Puerto-Nevado L, Portal-Nuñez S, et al · · 2017 · cited 117× · PMID 28060743 · DOI 10.18632/oncotarget.14472
  3. Immune Regulatory Processes of the Tumor Microenvironment under Malignant Conditions.
    Pansy K, Uhl B, Krstic J, Szmyra M, et al · · 2021 · cited 87× · PMID 34948104 · DOI 10.3390/ijms222413311
  4. Targeting the JAK/STAT pathway in solid tumors.
    Qureshy Z, Johnson DE, Grandis JR. · · 2020 · cited 76× · PMID 33521321 · DOI 10.20517/2394-4722.2020.58
  5. Combined inhibition of JAK2-STAT3 and SMO-GLI1/tGLI1 pathways suppresses breast cancer stem cells, tumor growth, and metastasis.
    Doheny D, Sirkisoon S, Carpenter RL, Aguayo NR, et al · · 2020 · cited 62× · PMID 32929154 · DOI 10.1038/s41388-020-01454-1
  6. 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
  7. ONC201 selectively induces apoptosis in cutaneous T-cell lymphoma cells via activating pro-apoptotic integrated stress response and inactivating JAK/STAT and NF-κB pathways.
    Ni X, Zhang X, Hu CH, Langridge T, et al · · 2017 · cited 24× · PMID 28977902 · DOI 10.18632/oncotarget.18688
  8. Metabolic reprogramming in cancer and senescence.
    Zhang Y, Tang J, Jiang C, Yi H, et al · · 2025 · cited 13× · PMID 40046406 · DOI 10.1002/mco2.70055

Verify or expand the search:

Other trials of Pacritinib

Trials testing the same drug.

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

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