Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT01859351
Status:
TERMINATED
Last Update Posted:
2014-05-16
First Post:
2013-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study of WX-037 Alone and in Combination With WX-554 in Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Study terminated for business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2013-04-23', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose limiting toxicities', 'timeFrame': 'during cycle 1 (21days) of treatment with WX-037'}, {'measure': 'Incidence of Dose Limiting toxicities', 'timeFrame': 'during cycle 1 (21 days) of treatment with WX-037 and WX-554'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse Events and serious adverse events', 'timeFrame': 'from cycle 1 day 1 until treatment discontinuation, an estimated average of 18 weeks'}, {'measure': 'Assessment of PK variables, peak plasma concentration (Cmax), area under the curve (AUC)', 'timeFrame': 'two PK profiles in cycle 1'}, {'measure': 'Determination of PD markers; changes from baseline in biomarkers of pathway inhibition', 'timeFrame': 'predose until treatment discontinuation, an estimated average of 18 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumours']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety of escalating doses of the novel PI3K inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these two novel compounds could provide targeted inhibition of both pathways to block tumour growth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced, metastatic and/or progressive solid tumors for whom there is no effective standard therapy available (for part 2 in addition patients for whom their PI3K pathway is deregulated)\n* Evaluable or measurable disease\n* Has normal organ function; is no greater than 2 on the ECOG performance scale\n* Negative hCG test in women of childbearing potential\n\nExclusion Criteria:\n\n* History of diabetes requiring daily medication or history of grade 3 or more fasting hyperglycemia\n* Patients with major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study\n* Clinical significant, unresolved toxicity from previous anti-cancer therapy\n* Patients who previously received a MEK inhibitor (for combination part only)\n* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs\n* Known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm Hg or patient considered at risk of retinal vein thrombosis (combination part only)\n* Known HIV positivity or active hepatitis B or C infection\n* History of clinically significant cardiac condition'}, 'identificationModule': {'nctId': 'NCT01859351', 'briefTitle': 'Phase I Study of WX-037 Alone and in Combination With WX-554 in Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heidelberg Pharma AG'}, 'officialTitle': 'A Phase I Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the PI3K Inhibitor WX-037, Given as a Single Agent and in Combination With the MEK Inhibitor WX-554, in Patients With Solid Tumors', 'orgStudyIdInfo': {'id': 'WX/90-001'}, 'secondaryIdInfos': [{'id': '2012-004552-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WX-037', 'description': 'PI3K inhibitor', 'interventionNames': ['Drug: WX-037']}, {'type': 'EXPERIMENTAL', 'label': 'WX-037 in combination with WX-554', 'description': 'PI3K inhibitor in combination with MEK inhibitor', 'interventionNames': ['Drug: WX-037', 'Drug: WX-554']}], 'interventions': [{'name': 'WX-037', 'type': 'DRUG', 'armGroupLabels': ['WX-037', 'WX-037 in combination with WX-554']}, {'name': 'WX-554', 'type': 'DRUG', 'armGroupLabels': ['WX-037 in combination with WX-554']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' Foundation Trust, Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Udai Banerji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg Pharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}