Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT03326102
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be assigned to DHP107 or IV paclitaxel in a ratio of 2:1 (n=48 to DHP107 and n=24 to IV paclitaxel)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2017-10-25', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate(ORR)', 'timeFrame': 'Every 8 weeks upto 18 months from randomization date', 'description': 'ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria'}], 'secondaryOutcomes': [{'measure': 'Progression free survival(PFS)', 'timeFrame': 'Up to 18 months from randomization date', 'description': 'PFS is defined as the time from date of randomization until the date of first documented progression or death.'}, {'measure': 'Overall survival(OS)', 'timeFrame': 'Up to 36 months from FPI', 'description': 'OS is defined as the time from the date of inclusion to the date of death.'}, {'measure': 'Time to treatment failure(TTF)', 'timeFrame': 'Up to 18 months from randomization date', 'description': 'TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.'}, {'measure': 'Duration of response(DOR)', 'timeFrame': 'Up to 18 months from randomization date', 'description': 'DOR is the time between the initial response to therapy and subsequent disease progression or relapse.'}, {'measure': 'Disease control rate(DCR)', 'timeFrame': 'Up to 18 months from randomization date', 'description': 'DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization.'}, {'measure': 'Quality of life(QoL)', 'timeFrame': 'after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months', 'description': 'Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)'}, {'measure': 'PK', 'timeFrame': 'The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of Cycle 1', 'description': 'Pharmacokinetics is defined as the study of the time course of drug absorption, distribution, metabolism, and excretion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'DHP107', 'Paclitaxel', 'Liporaxel'], 'conditions': ['Recurrent or Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination\n2. Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples\n3. Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting\n4. Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.\n5. Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).\n\nKey Exclusion Criteria:\n\n1. Subjects who have received prior taxane therapy in the metastatic setting\n2. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.\n3. Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry\n4. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.\n5. Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).'}, 'identificationModule': {'nctId': 'NCT03326102', 'acronym': 'OPERA', 'briefTitle': 'Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daehwa Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-national,Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®,Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)', 'orgStudyIdInfo': {'id': '107CS-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DHP107', 'description': 'The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1.\n\nTotal 48 subjects (including PK subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days.', 'interventionNames': ['Drug: DHP107']}, {'type': 'EXPERIMENTAL', 'label': 'IV paclitaxel', 'description': 'Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)', 'interventionNames': ['Drug: IV Paclitaxel']}], 'interventions': [{'name': 'DHP107', 'type': 'DRUG', 'otherNames': ['Liporaxel®, Oral Paclitaxel'], 'description': 'DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days', 'armGroupLabels': ['DHP107']}, {'name': 'IV Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol Injection'], 'description': 'IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)', 'armGroupLabels': ['IV paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Research Institute (CRI)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco (UCSF)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Regional Hospital (BRRH)', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34607', 'city': 'Weeki Wachee', 'state': 'Florida', 'country': 'United States', 'facility': 'ASCLEPES Research Center(ARC)', 'geoPoint': {'lat': 28.51555, 'lon': -82.57288}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute(SLCI)", 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center(KUMC)', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Health System Research Institute (AAHS)', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital(MGH)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center of Medical Research(MCMR)', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '55426', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro-Minnesota Community Oncology Research Consortium (MMCORC)', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Research Foundation (NCRF)', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center (UPMC)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '775 20', 'city': 'Olomouc', 'state': 'I.P. Pavlova 6', 'country': 'Czechia', 'facility': 'Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '1106268 31', 'city': 'Hořovice', 'state': 'K Nemocnici', 'country': 'Czechia', 'facility': 'Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)', 'geoPoint': {'lat': 49.83597, 'lon': 13.90268}}, {'zip': '128 08', 'city': 'Prague', 'state': 'U Nemocnice 499/2', 'country': 'Czechia', 'facility': 'Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Hope Rugo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'David Weng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anne Arundel Health System Research Institute (AAHS)'}, {'name': 'Neelima Vidula, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital (MGH)'}, {'name': 'Adam Brufsky, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center (UPMC)'}, {'name': 'Timothy Pluard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Saint Luke's Cancer Institute(SLCI)"}, {'name': 'Priyanka Sharma, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center(KUMC)'}, {'name': 'Jane Skelton, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boca Raton Regional Hospital (BRRH)'}, {'name': 'Richard Caradonna, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASCLEPES Research Center(ARC)'}, {'name': 'Yan Ji, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metro-Minnesota Community Oncology Research Consortium (MMCORC)'}, {'name': 'Craig Gordon, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan Center of Medical Research(MCMR)'}, {'name': 'Ghassan Aljazayrly, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Research Institute (CRI)'}, {'name': 'John Ellerton, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nevada Cancer Research Foundation (NCRF)'}, {'name': 'Bohuslav Melichar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)'}, {'name': 'Martin Smakal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)'}, {'name': 'Martina Zimovjanova, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daehwa Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}