{
  "topic": {
    "stem": "MOMELOTINIB_MF_AUTO_2",
    "name": "Momelotinib in anaemic MF (broader)",
    "ncts": [
      "NCT06517875",
      "NCT07104799",
      "NCT01423058",
      "NCT02101268",
      "NCT01236638",
      "NCT07498205",
      "NCT04176198",
      "NCT01969838"
    ],
    "drug_patterns": [
      "momelotinib"
    ],
    "condition_patterns": [
      "myelofibrosis"
    ]
  },
  "trials": [
    {
      "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": "NCT06517875",
        "aact_title": "Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis",
        "aact_acronym": "ODYSSEY",
        "start_date": "2025-02-28",
        "primary_completion_date": "2026-10-14",
        "aact_intvs": [
          "momelotinib",
          "luspatercept"
        ],
        "aact_conditions": [
          "myelofibrosis; primary myelofibrosis; post-polycythemia vera myelofibrosis; post-essential thrombocythemia myelofibrosis",
          "primary myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Percentage of Participants with TI Response by Week 24",
        "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": "NCT07104799",
        "aact_title": "Momelotinib During and After HCT in Myelofibrosis",
        "aact_acronym": "",
        "start_date": "2026-02-23",
        "primary_completion_date": "2028-01-31",
        "aact_intvs": [
          "momelotinib"
        ],
        "aact_conditions": [
          "hematopoietic cell transplantation (hct)",
          "myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Maximum Tolerated Dose (MTD) of Momelotinib",
        "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": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT01423058",
        "aact_title": "Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis",
        "aact_acronym": "",
        "start_date": "2011-08-31",
        "primary_completion_date": "2014-06-30",
        "aact_intvs": [
          "momelotinib"
        ],
        "aact_conditions": [
          "post-essential thrombocythemia myelofibrosis",
          "post-polycythemia vera",
          "primary myelofibrosis"
        ],
        "pmid": "27634203",
        "pubmed_year": 2017,
        "pubmed_doi": "10.3324/haematol.2016.148924",
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "To determine the safety of momelotinib by characterization and relationship of adverse events, affects on vital signs and laboratory parameters, and QTc intervals as measured by electrocardiogram (ECG",
        "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": "NCT02101268",
        "aact_title": "Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF",
        "aact_acronym": "Simplify 2",
        "start_date": "2014-06-19",
        "primary_completion_date": "2016-07-28",
        "aact_intvs": [
          "momelotinib",
          "best available therapy (bat)"
        ],
        "aact_conditions": [
          "post-essential thrombocythemia myelofibrosis (post-et mf)",
          "post-polycythemia vera (post-pv)",
          "primary myelofibrosis (pmf)"
        ],
        "pmid": "40535755",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1002/jha2.70075",
        "aact_per_arm_counts": {
          "BG000": 104,
          "BG001": 52
        },
        "aact_primary_outcome_measure": "Splenic Response Rate at Week 24",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "7.0"
          ],
          [
            "OG001",
            "3.0"
          ],
          [
            "OG000",
            "97.0"
          ],
          [
            "OG001",
            "49.0"
          ],
          [
            "OG000",
            "27.0"
          ],
          [
            "OG001",
            "3.0"
          ],
          [
            "OG000",
            "76.0"
          ],
          [
            "OG001",
            "48.0"
          ],
          [
            "OG000",
            "45.0"
          ],
          [
            "OG001",
            "11.0"
          ]
        ]
      }
    },
    {
      "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": "NCT01236638",
        "aact_title": "Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)",
        "aact_acronym": "",
        "start_date": "2010-11-30",
        "primary_completion_date": "2014-06-30",
        "aact_intvs": [
          "momelotinib"
        ],
        "aact_conditions": [
          "post-essential thrombocythemia myelofibrosis",
          "post-polycythemia vera myelofibrosis",
          "primary myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "To determine the long term safety and tolerability of orally-administered CYT387 in patients with PMF or post-ET/PV MF following completion of core study CCL09101",
        "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": "NCT07498205",
        "aact_title": "Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts",
        "aact_acronym": "APEX-MF",
        "start_date": "2026-08-08",
        "primary_completion_date": "2029-08-08",
        "aact_intvs": [
          "momelotinib",
          "ruxolitinib"
        ],
        "aact_conditions": [
          "myelofibrosis",
          "myelofibrosis (mf)"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "To estimate and compare the proportion of participants achieving a dual response [SVR35] and transfusion independence response from red blood cell transfusions.",
        "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": "NCT04176198",
        "aact_title": "A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis",
        "aact_acronym": "",
        "start_date": "2019-12-16",
        "primary_completion_date": "2027-04-30",
        "aact_intvs": [
          "nusivertib",
          "ruxolitinib",
          "momelotinib"
        ],
        "aact_conditions": [
          "myelofibrosis"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Determine the incidence of dose-limiting toxicities (DLTs)",
        "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": "NCT01969838",
        "aact_title": "Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis",
        "aact_acronym": "Simplify 1",
        "start_date": "2013-12-06",
        "primary_completion_date": "2016-09-12",
        "aact_intvs": [
          "momelotinib",
          "ruxolitinib",
          "placebo to match momelotinib"
        ],
        "aact_conditions": [
          "post-essential thrombocythemia myelofibrosis",
          "post-polycythemia vera myelofibrosis",
          "primary myelofibrosis"
        ],
        "pmid": "40535755",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1002/jha2.70075",
        "aact_per_arm_counts": {
          "BG000": 215,
          "BG001": 217
        },
        "aact_primary_outcome_measure": "Splenic Response Rate at Week 24",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "57.0"
          ],
          [
            "OG001",
            "64.0"
          ],
          [
            "OG000",
            "158.0"
          ],
          [
            "OG001",
            "153.0"
          ],
          [
            "OG000",
            "60.0"
          ],
          [
            "OG001",
            "89.0"
          ],
          [
            "OG000",
            "151.0"
          ],
          [
            "OG001",
            "122.0"
          ],
          [
            "OG000",
            "143.0"
          ],
          [
            "OG001",
            "107.0"
          ]
        ]
      }
    }
  ],
  "n_total": 8,
  "n_pass_all": 2,
  "verdict": "VIABLE",
  "pass_rate": 0.25
}