Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-01 @ 2:27 PM
Study NCT ID:
NCT02810756
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study With Improved Solubility Pazopanib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration', 'timeFrame': '24 hours', 'description': 'Concentration of pazopanib in plasma'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '1 week', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': '24 hours', 'description': 'Area under the plasma concentration versus time curve (AUC)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pharmacokinetics of Pazopanib']}, 'descriptionModule': {'briefSummary': 'The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced or metastatic cancer;\n* Able and willing to give written consent;\n* WHO performance status of 0, 1 or 2;\n* Able and willing to undergo blood sampling for PK analysis;\n* Minimal acceptable safety laboratory values;\n* Negative pregnancy test for female patients with childbearing potential;\n* Able and willing to swallow oral medication.\n\nExclusion Criteria:\n\n* Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;\n* Any treatment with CYP3A4, BCRP or PGP interfering drugs;\n* Patients who received treatment with Votrient(R) kess than 1 week ago;\n* Woman who are pregnant or breast feeding;\n* Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.'}, 'identificationModule': {'nctId': 'NCT02810756', 'briefTitle': 'Study With Improved Solubility Pazopanib', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Proof of Principle and Pharmacological Phase 0 Study With Improved Solubility Pazopanib', 'orgStudyIdInfo': {'id': 'N16PZN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated patients', 'interventionNames': ['Drug: New Pazopanib formulation']}], 'interventions': [{'name': 'New Pazopanib formulation', 'type': 'DRUG', 'armGroupLabels': ['Treated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 CX', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will remain confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}