Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT01332604
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C569670', 'term': '1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-03-31', 'studyFirstSubmitQcDate': '2011-04-08', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 30 days after last dose of study treatment'}, {'measure': 'Incidence of dose limiting toxicities (DLTs)', 'timeFrame': 'Up to Day 21 for Arm A and up to Day 28 for Arm B'}, {'measure': 'Nature of adverse events graded according to NCI CTCAE, v4.0', 'timeFrame': 'Up to 30 days after last dose of study treatment'}, {'measure': 'Nature of dose limiting toxicities (DLTs)graded according to NCI CTCAE, v4.0', 'timeFrame': 'Up to 28 days'}, {'measure': 'Severity of adverse events', 'timeFrame': 'Up to 30 days after last dose of study treatment'}], 'secondaryOutcomes': [{'measure': 'Total exposure from Time 0 to the last measurable concentration', 'timeFrame': 'Up to Day 2 for Arm B and up to Day 9 for Arm A'}, {'measure': 'Maximum observed plasma concentration', 'timeFrame': 'Up to Day 2 for Arm B and up to Day 9 for Arm A'}, {'measure': 'Minimum observed plasma concentration', 'timeFrame': 'Up to Day 2 for Arm B and up to Day 9 for Arm A'}, {'measure': 'Time to maximum observed plasma concentration', 'timeFrame': 'Up to Day 2 for Arm B and up to Day 9 for Arm A'}]}, 'conditionsModule': {'conditions': ['Solid Cancers']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented locally advanced or metastatic solid tumors for which established therapy is ineffective, not tolerable, or does not exist\n* Patients with histologically or cytologically documented locally advanced or metastatic breast cancer who have received at least one prior chemotherapy-based regimen for incurable disease (Arm A)\n* Patients with histologically or cytologically documented locally advanced or metastatic CRC who have not received prior oxaliplatin-based therapy within 1 year of initiation of study treatment. (Arm B)\n\nExclusion Criteria:\n\n* Prior anti-cancer therapy that fulfills the following criteria: a total of more than six courses of an alkylating agent, a total of more than four courses of carboplatin-containing chemotherapy regimens, and a total of more than two courses of nitrosoureas or mitomycin C, high-dose chemotherapy requiring stem-cell support, and irradiation to \\>= 25% of bone marrow-bearing areas\n* Current dyspnea at rest because of complications of advanced malignancy or other disease requiring continuous oxygen therapy\n* Known deficiency of dihydropyrimidine dehydrogenase (DPD)\n* Bisphosphonate therapy for symptomatic hypercalcemia\n* Known untreated or active central nervous system (CNS) metastases\n* Pregnancy, lactation, or breastfeeding\n\nFor Arm B:\n\n* Inadequately controlled hypertension\n* Prior history of hypertensive crisis or hypertensive encephalopathy\n* History of myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment\n* History of stroke or transient ischemic attacks within 6 months prior to the first dose of study treatment\n* Significant vascular disease within 6 months prior to the first dose of study treatment\n* History of hemoptysis within 1 month prior to the first dose of study treatment\n* Patients with one or more pulmonary tumor masses with evidence of cavitation\n* Evidence of bleeding diathesis or significant coagulopathy\n* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of study treatment\n* History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment\n* Clinical signs or symptoms of GI obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding\n* Evidence of abdominal free air not explained by paracentesis or recent surgical procedure\n* Serious, non-healing wound, active ulcer, or untreated bone fracture\n* The presence of an ulcerating breast cancer tumor will not render a patient ineligible\n* Proteinuria'}, 'identificationModule': {'nctId': 'NCT01332604', 'briefTitle': 'GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'PIM4945g'}, 'secondaryIdInfos': [{'id': 'GO00883', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: GDC-0980', 'Drug: capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: GDC-0980', 'Drug: bevacizumab', 'Drug: mFOLFOX6']}], 'interventions': [{'name': 'GDC-0980', 'type': 'DRUG', 'description': 'Oral escalating dose', 'armGroupLabels': ['A', 'B']}, {'name': 'bevacizumab', 'type': 'DRUG', 'description': 'Intravenous repeating dose', 'armGroupLabels': ['B']}, {'name': 'capecitabine', 'type': 'DRUG', 'description': 'Oral repeating dose', 'armGroupLabels': ['A']}, {'name': 'mFOLFOX6', 'type': 'DRUG', 'description': 'Intravenous repeating dose', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}