Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 10:46 PM
Study NCT ID:
NCT01940133
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2013-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2013-09-06', 'studyFirstSubmitQcDate': '2013-09-06', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)', 'timeFrame': 'In average 1 year'}], 'secondaryOutcomes': [{'measure': 'To determine overall safety', 'timeFrame': '1 year', 'description': 'Incidence of SAEs, incidence and severity of all AEs, changes of vital signs, physical examinations, body weight, changes of routine laboratory assessments.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '29660598', 'type': 'DERIVED', 'citation': 'Wicki A, Brown N, Xyrafas A, Bize V, Hawle H, Berardi S, Cmiljanovic N, Cmiljanovic V, Stumm M, Dimitrijevic S, Herrmann R, Pretre V, Ritschard R, Tzankov A, Hess V, Childs A, Hierro C, Rodon J, Hess D, Joerger M, von Moos R, Sessa C, Kristeleit R. First-in human, phase 1, dose-escalation pharmacokinetic and pharmacodynamic study of the oral dual PI3K and mTORC1/2 inhibitor PQR309 in patients with advanced solid tumors (SAKK 67/13). Eur J Cancer. 2018 Jun;96:6-16. doi: 10.1016/j.ejca.2018.03.012. Epub 2018 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no therapy of proven efficacy is available.\n* Age ≥ 18\n* Evidence of tumor progression with measurable or evaluable disease.\n* Use of adequate contraceptive measures for male patients.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors)\n* Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.\n* Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP\\>150/100mmHg.\n* Pre-diagnosed diabetes mellitus.\n* Fasting glucose \\> 7.0 mmol/L or HbA1c \\> 6%.'}, 'identificationModule': {'nctId': 'NCT01940133', 'briefTitle': 'A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309', 'organization': {'class': 'INDUSTRY', 'fullName': 'PIQUR Therapeutics AG'}, 'officialTitle': 'Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'PQR309-001'}, 'secondaryIdInfos': [{'id': '2013-003441-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PQR309', 'description': 'Different dose evaluation', 'interventionNames': ['Drug: PQR309']}], 'interventions': [{'name': 'PQR309', 'type': 'DRUG', 'description': 'Dosing will be orally, once a day for the duration of the trial.', 'armGroupLabels': ['PQR309']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Andreas Wicki, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PIQUR Therapeutics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}