Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05266105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2022-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose Limiting Toxicities', 'timeFrame': 'From Cycle 1 Day 1 through C1 Day 28'}, {'measure': 'Characterization and Incidence in Adverse Events and Serious Adverse Events', 'timeFrame': 'From initial inform consent date through 30 days post last dose'}, {'measure': 'Plasma levels of OP-1250 and Palbociclib', 'timeFrame': 'Up to 9 months'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed and evaluable locally advanced or metastatic breast cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose\n* Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose\n* Prior radiotherapy must have been completed 2 weeks prior to first dose\n* Adequate safety laboratory tests\n* Willingness to use effective contraception\n\nExclusion Criteria:\n\n* Gastrointestinal disease\n* Significant hepatic disease\n* Significant cardiovascular disease\n* Significant ECG abnormalities\n* History of pulmonary embolism or high risk of thrombosis\n* Known HIV infection\n* Active infection (requiring antimicrobial therapy)\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT05266105', 'briefTitle': 'A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olema Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer', 'orgStudyIdInfo': {'id': 'OP-1250-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer', 'interventionNames': ['Drug: Palazestrant', 'Drug: Palbociclib']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': 'This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy', 'interventionNames': ['Drug: Palazestrant', 'Drug: Palbociclib']}], 'interventions': [{'name': 'Palazestrant', 'type': 'DRUG', 'otherNames': ['OP-1250'], 'description': 'Complete Estrogen Receptor Antagonist', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}, {'name': 'Palbociclib', 'type': 'DRUG', 'otherNames': ['Ibrance®️'], 'description': 'Palbociclib is an approved CDK 4/6 Inhibitor drug', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'overallOfficials': [{'name': 'Sue Johnson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Olema Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olema Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}