Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01003158
Status:
COMPLETED
Last Update Posted:
2014-07-10
First Post:
2009-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548875', 'term': 'AZD 8931'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-09', 'studyFirstSubmitDate': '2009-10-20', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monotherapy part: Assessment of adverse events, laboratory findings, physical examination, vital signs, ECG/UCG, chest X-ray, HRCT, SpO2 and ophthalmological examinations.', 'timeFrame': 'Full routine safety assessment on days 1-4, 8, 10, 14, 21, 28 then every 3 weeks after first dose of study drug'}, {'measure': 'Combination part: The contents of same assessment as Monotherapy.', 'timeFrame': 'Full routine safety assessment on days 1-5, 8, 15, 22, 28 then every 4 weeks after first dose of study drug'}], 'secondaryOutcomes': [{'measure': 'Combination Part: Pharmacokinetics of AZD8931 (tmax, Cmax, AUC0-10)', 'timeFrame': 'On Day D7 and Day D8: pre-dose then, 1, 2, 4, 6, 8 and 10 hours post dose'}, {'measure': 'Combination Part: Pharmacokinetics of paclitaxel (tmax, Cmax, AUC0-10)', 'timeFrame': 'On Days D1 and Day D8: pre-infusion then, 0.5, 1, 1.5, 2, 4, 6, 8, 10 and 24 (D1 only) hours post start of infusion'}, {'measure': 'Monotherapy Part: Pharmacokinetics of AZD8931 (Single dose plasma PK: AUC0-10, AUC0-12, AUC0-24, AUC0-t, AUC, Cmax, tmax, t1/2, CL/F, Vss/F. Multiple dose plasma PK: AUCss0-10, AUCss0-12, Cssmax, tssmax, Cssmin, CLss/F, RAC, linearity factor)', 'timeFrame': 'On single dose Day 1 (D1) and multiple dose Day 21 (R14): samples taken pre-dose then 1, 2, 4, 6, 8, 10, 24 (D1 only), 48 (D1 only) and 72 (D1 only) hours post dose. Day 10 (R3) and Day 14 (R7): pre-dose only'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'tumour', 'metastatic', 'breast cancer'], 'conditions': ['Neoplasms', 'Metastatic Cancer', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24875132', 'type': 'DERIVED', 'citation': 'Kurata T, Tsurutani J, Fujisaka Y, Okamoto W, Hayashi H, Kawakami H, Shin E, Hayashi N, Nakagawa K. Inhibition of EGFR, HER2 and HER3 signaling with AZD8931 alone and in combination with paclitaxel: phase i study in Japanese patients with advanced solid malignancies and advanced breast cancer. Invest New Drugs. 2014 Oct;32(5):946-54. doi: 10.1007/s10637-014-0112-7. Epub 2014 May 31.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1627&filename=D0102C00010_Clinical_Study_Protocol_combined_redacted_v02a.pdf', 'label': 'Reducted Protocol'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1627&filename=AZD8931_Clinical_Study_Protocol_Redacted.pdf', 'label': 'Clinical Study Protocol Redacted'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine if AZD8931 can be safely administered in Japanese patients alone and in combination with weekly paclitaxel. The study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer that is refractory to standard therapies, or for which no standard therapies exist (monotherapy part)\n* Patients suitable for Paclitaxel chemotherapy, who are not candidates for hormonal and anthracycline therapy (combination part)\n* Life expectancy more than 12 weeks\n\nExclusion Criteria:\n\n* Inadequate kidney, liver, heart, gastric, lung or eye function\n* Brain metastases\n* Hypersensitive to paclitaxel (combination part)'}, 'identificationModule': {'nctId': 'NCT01003158', 'briefTitle': 'Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open-label, Multiple-dose, Dose-escalation Study To Assess the Safety and Tolerability of AZD8931 Monotherapy in Japanese Patients With Advanced Solid Malignancies and in Combination With Paclitaxel in Japanese Female Patients With Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'D0102C00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy part', 'description': 'AZD8931 monotherapy', 'interventionNames': ['Drug: AZD8931']}, {'type': 'EXPERIMENTAL', 'label': 'Combination part', 'description': 'AZD8931 plus paclitaxel', 'interventionNames': ['Drug: AZD8931', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'AZD8931', 'type': 'DRUG', 'description': 'Tablet Oral bid', 'armGroupLabels': ['Combination part', 'Monotherapy part']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'IV once weekly for 3 weeks followed by a week off', 'armGroupLabels': ['Combination part']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Mary Stuart, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Takayasu Kurata, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kinki University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}