{
  "topic": {
    "stem": "PACRITINIB_MF_AUTO_2",
    "name": "Pacritinib in MF + cytopenia",
    "ncts": [
      "NCT04884191",
      "NCT02564536",
      "NCT02807077",
      "NCT07447817",
      "NCT07394153",
      "NCT02055781",
      "NCT02765724",
      "NCT02584777"
    ],
    "drug_patterns": [
      "pacritinib"
    ],
    "condition_patterns": [
      "myelofibrosis"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04884191",
        "aact_title": "Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib",
        "aact_acronym": "",
        "start_date": "2017-07-31",
        "primary_completion_date": "2019-09-04",
        "aact_intvs": [
          "pacritinib"
        ],
        "aact_conditions": [
          "post- essential thrombocythemia myelofibrosis",
          "post-polycythemia vera myelofibrosis",
          "primary myelofibrosis"
        ],
        "pmid": "34551507",
        "pubmed_year": 2022,
        "pubmed_doi": "10.3324/haematol.2021.279415",
        "aact_per_arm_counts": {
          "BG000": 52,
          "BG001": 55,
          "BG002": 54
        },
        "aact_primary_outcome_measure": "Spleen Volume Reduction Response (≥ 35%)",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "0.0"
          ],
          [
            "OG001",
            "2.0"
          ],
          [
            "OG002",
            "2.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG001",
            "1.0"
          ],
          [
            "OG002",
            "5.0"
          ],
          [
            "OG000",
            "1.0"
          ],
          [
            "OG001",
            "1.0"
          ],
          [
            "OG002",
            "2.0"
          ],
          [
            "OG000",
            "2.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02564536",
        "aact_title": "Pacritinib in Combination With Low Dose Decitabine in Intermediate-High Risk Myelofibrosis or Myeloproliferative Neoplasm (MPN)/Myelodysplastic Syndrome (MDS)",
        "aact_acronym": "",
        "start_date": "2017-06-30",
        "primary_completion_date": "2020-06-30",
        "aact_intvs": [
          "pacritinib",
          "decitabine"
        ],
        "aact_conditions": [
          "atypical chronic myeloid leukemia",
          "chronic myelomonocytic leukemia",
          "juvenile myelomonocytic leukemia"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Safety of regimen as measured by adverse events",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02807077",
        "aact_title": "PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects",
        "aact_acronym": "",
        "start_date": "2014-11-30",
        "primary_completion_date": "2015-07-31",
        "aact_intvs": [
          "pacritinib"
        ],
        "aact_conditions": [
          "myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "The maximum plasma concentration (Cmax)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT07447817",
        "aact_title": "Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias",
        "aact_acronym": "",
        "start_date": "2026-05-04",
        "primary_completion_date": "2030-05-24",
        "aact_intvs": [
          "pacritinib",
          "selinexor"
        ],
        "aact_conditions": [
          "myelofibrosis",
          "post-essential thrombocythemia myelofibrosis",
          "post-polycythemia vera myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Change in spleen volume",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT07394153",
        "aact_title": "Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia",
        "aact_acronym": "PACRIMYEL",
        "start_date": "2026-03-31",
        "primary_completion_date": "2027-12-31",
        "aact_intvs": [
          "pacritinib"
        ],
        "aact_conditions": [
          "myelofibrosis，mf"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Decrease in reticulin fibrosis in bone marrow (BM)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02055781",
        "aact_title": "Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia",
        "aact_acronym": "PAC326",
        "start_date": "2014-02-28",
        "primary_completion_date": "2016-04-30",
        "aact_intvs": [
          "pacritinib",
          "best available therapy"
        ],
        "aact_conditions": [
          "post-essential thrombocythemia myelofibrosis",
          "post-polycythemia vera myelofibrosis",
          "primary myelofibrosis"
        ],
        "pmid": "29522138",
        "pubmed_year": 2018,
        "pubmed_doi": "10.1001/jamaoncol.2017.5818",
        "aact_per_arm_counts": {
          "BG000": 104,
          "BG001": 107,
          "BG002": 100
        },
        "aact_primary_outcome_measure": "Spleen Volume Reduction",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "11.0"
          ],
          [
            "OG002",
            "2.0"
          ],
          [
            "OG000",
            "13.0"
          ],
          [
            "OG001",
            "16.0"
          ],
          [
            "OG001",
            "24.0"
          ],
          [
            "OG002",
            "10.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02765724",
        "aact_title": "Determine Pacritinib Pharmacokinetics in Impaired Hepatic Patients and Healthy Subjects",
        "aact_acronym": "",
        "start_date": "2015-01-31",
        "primary_completion_date": "2015-06-30",
        "aact_intvs": [
          "pacritinib"
        ],
        "aact_conditions": [
          "myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "To characterize the pharmacokinetic profile of a single 400-mg dose of pacritinib and its major metabolites in patients with hepatic impairment as compared to gender-, age-, and body mass index -match",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02584777",
        "aact_title": "A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis",
        "aact_acronym": "",
        "start_date": "2015-11-30",
        "primary_completion_date": "2017-09-30",
        "aact_intvs": [
          "pacritinib"
        ],
        "aact_conditions": [
          "primary myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Proportion of participants achieving a ≥35% reduction in spleen volume",
        "aact_outcome_count_rows": []
      }
    }
  ],
  "n_total": 8,
  "n_pass_all": 2,
  "verdict": "VIABLE",
  "pass_rate": 0.25
}