Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04543305
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2020-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe dose limiting toxicities (DLT) of PRT1419', 'timeFrame': 'Baseline through Day 28', 'description': 'Dose limiting toxicities will be evaluated through the first cycle'}, {'measure': 'To determine the maximally tolerated dose (MTD) and/or optimal biological dose (OBD)', 'timeFrame': 'Baseline through approximately 2 years', 'description': "The MTD and/or OBD will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome"}, {'measure': 'To determine the recommended phase 2 dose (RP2D) and schedule of PRT1419', 'timeFrame': 'Baseline through approximately 2 years', 'description': "The RP2D will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome"}], 'secondaryOutcomes': [{'measure': 'To describe the adverse event profile and tolerability of PRT1419', 'timeFrame': 'Baseline through approximately 2 years', 'description': 'Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy'}, {'measure': 'To describe the pharmacokinetic profile of PRT1419', 'timeFrame': 'Baseline through approximately 2 years', 'description': 'PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration'}, {'measure': 'To describe any anti-tumor activity of PRT1419', 'timeFrame': 'Baseline through approximately 2 years', 'description': 'Anti-tumor activity of PRT1419 will be based on the measurement of objective responses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma', 'Acute Myeloid Leukemia', 'Non Hodgkin Lymphoma', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with relapsed/refractory hematologic malignancies. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.', 'detailedDescription': 'This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients in two cohorts as part of a 28-day treatment cycle in adult patients with multiple myeloma (MM), non-Hodgkin\'s lymphoma (NHL), acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), high-risk myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) overlap syndrome. Cohort A will evaluate PRT1419 administered as monotherapy in patients with either AML, CMML and/or high-risk MDS or MDS/MPN overlap. Cohort B will evaluate PRT1419 administered as monotherapy in patients with NHL or MM. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Adequate organ function (bone marrow, hepatic, renal, cardiovascular)\n* Left ventricular ejection fraction of ≥50%\n* Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial\n* Patients must have recovered from the effects of any prior cancer related therapy, radiotherapy or surgery (toxicity ≤ Grade 1)\n* All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 14 days, whichever is longer before study entry\n* AML patients only: Pathologically confirmed diagnosis of AML as defined by the WHO Classification and patients with targeted mutations must have been treated with appropriate therapy for their disease\n\n * White blood cell count \\< 25 x 10\\^9/L. Hydrea or leukapheresis are permitted to meet this criterion.\n* CMML patients only: intermediate-2 or high risk per CMML-specific prognostic scoring system (CPSS) or clinical/molecular CPSS (CPSS-mol) criteria. Must have failed prior therapy with a hypomethylating agent.\n* MDS patients only: Intermediate, high, or very high risk by International Prognostic Scoring System-Revised \\[IPSS-R\\] criteria that is relapsed or refractory to approved therapies or MDS/MPN Overlap Syndrome (displaying both fibrosis and dysplastic features).\n* NHL patients only: Histologically or cytologically confirmed NHL, including B- and T-cell lymphomas that is relapsed or refractory or intolerant to approved therapies. Must have one lesion that can be measured for response\n* MM patients only: Measurable disease defined by one or more of the following: Serum M-protein ≥ 0.5 g/dL, Urine M-protein ≥ 200 mg/24 hours, Serum Free Light Chain (sFLC) \\> 10 mg/dL with normal serum FLC ratio. Presence of soft tissue plasmacytoma confirmed by imaging\n* NHL and MM patients only: must have the following lab values within 14 days prior to study Day 1:\n\n * ANC ≥1.0 x 10\\^3 μL\n * Platelet count ≥50,000 μL\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the components of PRT1419\n* Female patients who are pregnant or lactating\n* Mean QTcF interval of \\>480 msec\n* History of heart failure, additional risk factors for arryhthmias or requiring concomitant medications that prolong the QT/QTc interval\n* Hematopoietic stem-cell transplant \\< 90 days or have GVHD Grade \\>1 at study entry\n* Uncontrolled intercurrent illnesses\n* Treatment with strong inhibitors of CYP2C8 and/or P-glycoprotein for which there are no therapeutic substitutions\n* Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption\n* HIV positive; known active hepatitis B or C\n* Prior exposure to an MCL1 inhibitor\n* History of another malignancy except:\n\n * Malignancy treated with curative intent with no known active disease for \\>2 years at study entry\n * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n * Adequately treated carcinoma in situ without evidence of disease\n * Other concurrent low-grade malignancies (i.e chronic lymphocytic leukemia (Rai 0)) may be considered after consultation with Sponsor.'}, 'identificationModule': {'nctId': 'NCT04543305', 'briefTitle': 'A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prelude Therapeutics'}, 'officialTitle': 'A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'PRT1419-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRT1419', 'description': 'PRT1419 will be administered orally', 'interventionNames': ['Drug: PRT1419']}], 'interventions': [{'name': 'PRT1419', 'type': 'DRUG', 'description': 'PRT1419 will be administered orally', 'armGroupLabels': ['PRT1419']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32742', 'city': 'Lake Mary', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 28.75888, 'lon': -81.31784}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prelude Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}