Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-04 @ 9:37 PM
Study NCT ID:
NCT01875705
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619637', 'term': 'ravoxertinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Maximum tolerated dose', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Dose-limiting toxicities', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Pharmacokinetics: Area under the concentration-time curve', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Pharmacokinetics: Maximum plasma concentrations', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Pharmacokinetics: Minimum plasma concentrations', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Pharmacokinetics: Time to maximum plasma concentration', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Pharmacokinetics: Apparent terminal elimination half-life', 'timeFrame': 'Approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'To assess the PD effects of GDC-0994, as measured by changes in molecular biomarkers in pre- and post-treatment tumor tissues\\n', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)', 'timeFrame': 'Approximately 2 years'}]}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable\n* Evaluable disease or disease measurable per RECIST 1.1\n* Life expectancy \\>= 12 weeks\n* Adequate hematologic and end organ function\n* Consent to provide archival tissue\n\nExclusion Criteria:\n\n* History of prior significant toxicity from another MEK or ERK inhibitor requiring discontinuation of treatment\n* History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months\n* Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment\n* History of glaucoma\n* Intraocular pressure \\> 21 mmHg as measured by tonometry\n* Predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy\n* History of retinal vein occlusion (RVO), neurosensory retinal detachment, or neovascular macular degeneration\n* Allergy or hypersensitivity to components of the GDC-0994 formulation\n* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1\n* Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1\n* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment\n* Prior anti-cancer therapy within 28 days or 5 times the half-life whichever is longer\n* Current severe, uncontrolled systemic disease\n* History of clinically significant cardiac dysfunction\n* Pregnancy, lactation, or breastfeeding\n* Active autoimmune disease\n* Inability or unwillingness to swallow pills\n* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms\n* Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus\n* Any condition requiring warfarin or thrombolytic anticoagulants\n* Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01875705', 'briefTitle': 'A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'GO28885'}, 'secondaryIdInfos': [{'id': '2013-000566-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage I-Dose Escalation', 'interventionNames': ['Drug: GDC-0994']}, {'type': 'EXPERIMENTAL', 'label': 'Stage II-Cohort-Expansion', 'interventionNames': ['Drug: GDC-0994']}], 'interventions': [{'name': 'GDC-0994', 'type': 'DRUG', 'description': 'Escalating doses of GDC-0994 until maximum tolerated dose is reached', 'armGroupLabels': ['Stage I-Dose Escalation']}, {'name': 'GDC-0994', 'type': 'DRUG', 'description': 'Recommended dose determined in Stage I-Dose Escalation phase, until disease progression', 'armGroupLabels': ['Stage II-Cohort-Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center; Medical Oncology', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Can Inst', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Inst.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy; Departement Oncologie Medicale', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}