Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-04 @ 8:43 AM
Study NCT ID:
NCT03446495
Status:
UNKNOWN
Last Update Posted:
2018-02-26
First Post:
2018-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077606', 'term': 'Trabectedin'}, {'id': 'C041277', 'term': '1-dodecylpyridoxal'}], 'ancestors': [{'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Patient will be followed during 37 weeks', 'description': 'ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1).'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Patient will be followed during 37 weeks', 'description': 'PFS is defined as the time from the 1st treatment cycle until objective tumor progression or death'}, {'measure': 'Safety according to CTCAE v4.0', 'timeFrame': 'Patient will be followed during 37 weeks', 'description': 'To assess patient safety and the tolerance of trabectedin + PLD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian cancer, trabectedin, recurrent ovarian cancer'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsed ovarian cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age\\>18\n* Histologically proven epithelial ovarian cancer\n* ECOG 0-1\n* Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months\n* With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication\n* Prior treatment with 1 or more chemotherapy regimen\n\nExclusion Criteria:\n\n* Platinum resistant disease: PFI \\< 6 months (progression within six months after first-line platinum-based chemotherapy)\n* Unwilling or unable to have a central venous catheter\n* Patients with hepatic impairment (Patients with elevated bilirubin)\n* Patients with renal impairment (Patients with serum creatinine \\>1.5 mg/dL)\n* Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)\n* Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex)\n* AIDS-related Kaposi's sarcoma\n* Lactation or pregnancy"}, 'identificationModule': {'nctId': 'NCT03446495', 'acronym': 'Renaissance', 'briefTitle': 'An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Scientific Medical Society, Kazakhstan'}, 'officialTitle': 'A Non-interventional, Multicenter Study of the Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer', 'orgStudyIdInfo': {'id': 'R279741OVC4001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trabectedin + PLD', 'description': 'Trabectedin + PLD according to SmPC', 'interventionNames': ['Drug: Trabectedin + PLD']}], 'interventions': [{'name': 'Trabectedin + PLD', 'type': 'DRUG', 'description': 'Combination of Trabectedin + PLD: PLD 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks.', 'armGroupLabels': ['Trabectedin + PLD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Almaty', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Rinat Baituganov, PhD', 'role': 'CONTACT', 'email': 'almaty.onco@mail.ru', 'phone': '+7 (727) 382 61 60'}, {'name': 'Rinat Baituganov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Almaty oncological center', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'city': 'Almaty', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Sayakhat Olzhaev, PhD', 'role': 'CONTACT', 'email': 'arod_priem@mail.ru', 'phone': '+77273993881'}, {'name': 'Sayakhat Olzhaev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Almaty regional oncological dispensary', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'city': 'Almaty', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Dilara Kaidarova, Academician', 'role': 'CONTACT', 'email': 'admin@ncc.org.kz', 'phone': '+ 7 727 292 00 61'}, {'name': 'Dilara Kaidarova, academician', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kazakh institute of oncology and radiology', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'city': 'Almaty', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Oxana Shatkovskaya, PhD', 'role': 'CONTACT', 'email': '1972arty@mail.ru', 'phone': '+77014147124'}, {'name': 'Oxana Shatkovskaya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kazakh institute of oncology and radiology', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'city': 'Astana', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Mukhtar Tuleutaev, PhD', 'role': 'CONTACT', 'phone': '+77172560073'}, {'name': 'Mukhtar Tuleutaev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Astana Oncology Center', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'city': 'Kyzylorda', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Saken Sergaziyev, PhD', 'role': 'CONTACT', 'email': 'onkolog_kzo@mail.ru', 'phone': '+77242235468'}, {'name': 'Saken Sergaziyev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyzylorda regional Oncological center', 'geoPoint': {'lat': 44.85278, 'lon': 65.50917}}, {'city': 'Oral', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Esengeldy Rabaev, PhD', 'role': 'CONTACT'}, {'name': 'Esengeldy Rabaev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Kazakhstan regional oncology dispensary', 'geoPoint': {'lat': 51.24601, 'lon': 51.42558}}, {'city': 'Petropavl', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Ermek Abdrimov, PhD', 'role': 'CONTACT', 'email': 'sko.ood@mail.ru', 'phone': '+77152463201'}, {'name': 'Ermek Abdrimov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Kazakhstan Regional Oncology Center', 'geoPoint': {'lat': 54.87343, 'lon': 69.15065}}, {'city': 'Shymkent', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Dauranbek Arybzhanov, PhD', 'role': 'CONTACT', 'email': 'onco-shm@mail.ru', 'phone': '+77252221904'}, {'name': 'Dauranbek Arybzhanov, ЗрВ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'South Kazakhstan regional oncologic dispensary', 'geoPoint': {'lat': 42.30988, 'lon': 69.60042}}, {'city': 'Ust-Kamenogorsk', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Gulmira Sagidullina, PhD', 'role': 'CONTACT', 'email': 'vkood_poliklinika@mail.ru', 'phone': '+77112705976'}, {'name': 'Gulmira Sagidullina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'East Kazakhstan Regional Oncology Dispensary', 'geoPoint': {'lat': 49.97143, 'lon': 82.60586}}], 'centralContacts': [{'name': 'Suriya Yessentaeva, PhD', 'role': 'CONTACT', 'email': 'surya_esentay@mail.ru', 'phone': '+77077942910'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suriya Yessentayeva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair', 'investigatorFullName': 'Suriya Yessentayeva', 'investigatorAffiliation': 'Scientific Medical Society, Kazakhstan'}}}}