[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kura Oncology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":219},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,56,72,84,127,156,191],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100593505","phase-3-studies-to-assess-ziftomenib-in-combination-with-venaza-or-73-in-patients-with-untreated-npm1-m-or-kmt2a-r-aml-100593505",false,"NCT07007312","Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML","Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia","Key Inclusion Criteria:\n\nThe following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:\n\n* Age ≥18 years at time of signing the informed consent form.\n* Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Adequate liver and kidney function according to protocol requirements.\n* A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male with a female partner of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention.\n* NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA):\n\n  1. Documented NPM1-m.\n  2. Patients considered ineligible for Intensive Therapy defined by the following:\n\n     * i. Age ≥75, OR\n     * ii. Age \\\u003C75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria.\n* INTENSIVE THERAPY STUDY ONLY (7+3):\n\n  1. Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible).\n  2. Documented FLT3 wild-type or ITD ratio \\\u003C0.05 OR ineligible to receive FLT3-targeted therapy (medically ineligible or mutation in which FLT3 inhibition is not SOC). Lack of access to an FLT3 inhibitor is not considered \"ineligible\" for FLT3-targeted therapy.\n  3. Ejection fraction of ≥50%.\n  4. Fit for Intensive Therapy per Investigator opinion.\n\nKey Exclusion Criteria:\n\n* Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control).\n* Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma.\n* Known history of BCR-ABL mutation.\n* History of other active concurrent malignancies prior to study entry except:\n\n  1. Basal cell skin cancer or localized squamous cell cancer of the skin\n  2. Previous malignancy confined and locally resected (or treated with other modalities) with curative intent\n  3. Prostate or breast cancer receiving adjuvant hormonal therapy.\n* Active central nervous system (CNS) involvement by AML.\n* Clinical signs\u002Fsymptoms of leukostasis or white blood cells (WBC) \\>25×10\\^9\u002FL prior to start of ziftomenib\u002Fplacebo. Note: Hydroxyurea and\u002For leukapheresis are permitted to meet this criterion.\n* Known uncontrolled HIV infection or known active hepatitis B virus, hepatitis C virus infection, or other uncontrolled infection.\n* Uncontrolled intercurrent illness including but not limited to, cardiac illness as defined in the protocol.\n* Women who are pregnant or lactating.","ALL","18 Years",{"count":19,"type":20},1300,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells.\n\nThis protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance.\n\nThe physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called \"double-blinded\".",[26],"Acute Myeloid Leukemia (AML)",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"AML","Hematological malignancy","KMT2A","NPM1","Menin","Acute Leukemia","Leukemia","Acute Myeloid Leukemia","Newly diagnosed AML","Newly diagnosed KMT2A-r AML","Newly diagnosed NPM1m AML","Untreated AML","Untreated NPM1m AML","Untreated KMT2A-r AML","MLL","RECRUITING","2026-06-26",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":47},"2025-09-26",{"date":51,"type":20},"2031-11",{"name":53,"class":54},"Kura Oncology, Inc.","INDUSTRY",82,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":71,"locationsCount":4},"100496002","expanded-access-to-ziftomenib-100496002","NCT05738538","Expanded Access to Ziftomenib","Inclusion\u002FExclusion Criteria:\n\n* Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).\n* Adult, ages 18+.\n* Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. For newly diagnosed AML patients with either NPM1-mutant, or KMT2A-rearranged AML, ziftomenib therapy will be considered for patients not eligible for ongoing clinical trials. In the case of patients with KMT2A-rearranged AML, Expanded Access to ziftomenib will only be provided for use in combination with FDA-approved therapies currently under clinical investigation at Kura Oncology (e.g., venetoclax + azacitidine, cytarabine + daunorubicin).\n* Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.\n* Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology.","EXPANDED_ACCESS","Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL) with KMT2A rearrangements, or Acute Myeloid Leukemia (AML), with KMT2A rearrangements, or frontline AML patients with NPM1 mutations.\n\nTo request access, use Responsible Party contact information provided in this record.\n\nExpanded access for ziftomenib is only available in the United States.",[65,66,67],"Acute Lymphoblastic Leukemia, With KMT2A Rearrangements","Acute Myeloid Leukemia, With NPM1 Mutations","Acute Myeloid Leukemia, With KMT2A Rearrangements","AVAILABLE","2026-06-24",{"date":46,"type":47},{"name":53,"class":54},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":4,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":82,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":83,"locationsCount":4},"100424617","expanded-access-to-tipifarnib-100424617","NCT04809233","Expanded Access to Tipifarnib","Kuraoncology","Inclusion\u002FExclusion Criteria:\n\nDiagnosed with HRAS mutations or peripheral T Cell Lymphoma (PTCL).\n\nAdult, ages 18+.\n\nHave exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.\n\nIs ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.\n\nMeets any other pertinent medical criteria for access to the investigational drug, as established by the Kura Oncology","Requests for single patient expanded access to tipifarnib may be considered for adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL).\n\nTo request access, use Responsible Party contact information provided in this record.\n\nExpanded access for tipifarnib is only available in the United States.",[81],"HRAS Mutations or Peripheral T Cell Lymphoma (PTCL)",{"date":46,"type":47},{"name":53,"class":54},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":105,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100518120","phase-1-ko-2806-monotherapy-and-combination-therapies-in-advanced-solid-tumors-100518120","NCT06026410","KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors","Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors","FIT-001","Inclusion Criteria:\n\n* At least 18 years of age.\n* Histologically or cytologically confirmed advanced solid tumors\n\n  * Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: HRAS-mutant and\u002For amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and\u002For NRAS, and\u002For HRAS-mutant and\u002For amplified NSCLC or CRC; KRAS-mutant and\u002For amplified PDAC\n  * Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.\n  * Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC.\n  * Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.\n* Acceptable liver, renal, endocrine, and hematologic function.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.\n* Prior treatment with an FTI or HRAS inhibitor.\n* Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.\n* Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.\n* Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.\n* Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.\n* Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.\n* Inadequate cardiac and\u002For vascular function, including receipt of treatment for unstable angina, myocardial infarction, and\u002For cerebrovascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.\n* Other invasive malignancy within 2 years.\n* Other protocol-defined exclusion criteria may apply.",{"count":93,"type":20},300,[95],"PHASE1","This first-in-human (FIH) dose-escalation and dose-validation\u002Fexpansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.",[98,99,100,101,102,103,104],"Solid Tumors With HRAS Alterations","Non Small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Renal Cell Carcinoma (Kidney Cancer)","Non Clear Cell Renal Cell Carcinoma (nccRCC)",[106,107,108,109,110,111,112,113,114,115,116,117],"HRAS","KRAS","NRAS","Farnesyltransferase inhibitor (FTI)","Tyrosine Kinase inhibitor (TKI)","Phase 1","KRAS G12C inhibitor","NSCLC","ccRCC","RCC","PDAC","CRC","2026-06-04",{"date":120,"type":47},"2026-06-08",{"date":122,"type":47},"2023-10-18",{"date":124,"type":20},"2027-04",{"name":53,"class":54},38,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228","NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.",{"count":135,"type":20},171,[95],"The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[28,139,140,141,142,143,34,35,144,145,33,146],"AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Neoplasms by Histologic Type","2026-04-10",{"date":149,"type":47},"2026-04-14",{"date":151,"type":47},"2024-02-22",{"date":153,"type":20},"2027-08",{"name":53,"class":54},45,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":174,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100495744","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-ziftomenib-in-combination-with-venetoclaxazacitidine-venetoclax-73-or-73quizartinib-in-patients-with-aml-100495744","NCT05735184","A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax\u002FAzacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML","Phase 1 Study of Venetoclax\u002FAzacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine\u002FDaunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed\u002Frefractory AML\n\n  * Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Adequate liver, renal, and cardiac function according to protocol defined criteria\n* A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or use a double barrier method of contraception from the time of screening through 180 days following the last dose of study intervention\n\n  * Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose\n\nKey Exclusion Criteria:\n\n* Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia\n* Known history of BCR-ABL alteration\n* Advanced malignant hepatic tumor\n* Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery\n* Active central nervous system (CNS) involvement by AML.\n* Clinical signs\u002Fsymptoms of leukostasis or WBC \\> 25,000 \u002F microliter. Hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet this criterion\n* Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia\n* Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection\n* For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia\n* For relapsed\u002Frefractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \\\u003C 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug\n* Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol\n* Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)\n\n  * Arm A and Arm B: \\>480 ms on triplicate ECGs\n  * Arm C: \\>450 ms on triplicate ECGs\n* Uncontrolled infection\n* Women who are pregnant or lactating\n* An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled\u002Fprogressing\n* Patients who have active GVHD requiring \\>0.5 mg\u002Fkg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment",{"count":164,"type":20},420,[95],"Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.\n\nThis protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.\n\nThe purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.",[35,168,169,139,170,171,142,141,172,173],"Mixed Lineage Leukemia Gene Mutation","Refractory AML","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, in Relapse","Myeloid Sarcoma","Nucleophosmin 1-mutated Acute Myeloid Leukemia",[34,175,28,29,30,31,32,33,36,39,176,177,178,179,180,169,171,181],"Myeloid","venetoclax","cytarabine","daunorubicin","KMT2A-r","NPM1 mutation","quizartinib","2026-03-11",{"date":184,"type":47},"2026-03-13",{"date":186,"type":47},"2023-07-18",{"date":188,"type":20},"2030-04",{"name":53,"class":54},44,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":208,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},"100566443","phase-1-a-study-of-ziftomenib-in-combination-with-imatinib-in-patients-with-advanced-gastrointestinal-stromal-tumors-gist-100566443","NCT06655246","A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)","A Phase 1a\u002F1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure","Key Inclusion Criteria:\n\n* Documented diagnosis of advanced\u002Fmetastatic KIT-mutant GIST.\n* Documented disease progression on imatinib as current or prior therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.\n* At least 1 measurable lesion per RECIST v1.1 modified for GIST.\n* Negative pregnancy test for participants of childbearing potential.\n* Adequate organ function per protocol requirements.\n* Resolution of all clinically significant toxicities from prior therapy to \\\u003CGrade 1 (or participant baseline) within 1 week before the first dose of study intervention.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.\n\nKey Exclusion Criteria:\n\n* Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.\n* History of prior or current cancer that has potential to interfere with obtaining study results.\n* Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention.\n* Active central nervous system metastases.\n* Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Mean corrected QT interval (QTcF) greater than 470ms.\n* Left ventricular ejection fraction (LVEF) \\\u003C50%.\n* Major surgery within 2 weeks before the first dose of study intervention.\n* Is pregnant or breastfeeding.\n* Gastrointestinal abnormalities that may impact taking study intervention by mouth.\n* Actively bleeding, excluding hemorrhoidal or gum bleeding.",{"count":199,"type":20},157,[95],"In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.",[203,204,205,206,207],"Gastrointestinal Stromal Tumor (GIST)","Gastrointestinal Stromal Cancer","Gastrointestinal Stromal Neoplasm","Gastrointestinal Stromal Tumor, Malignant","Gastrointestinal Stromal Cell Tumors",[209,204,205],"Gastrointestinal Stromal Tumor","2026-02-03",{"date":212,"type":47},"2026-02-05",{"date":214,"type":47},"2025-03-27",{"date":216,"type":20},"2028-12",{"name":53,"class":54},32,""]