Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-01 @ 1:53 AM
Study NCT ID:
NCT00811993
Status:
TERMINATED
Last Update Posted:
2016-11-02
First Post:
2008-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558734', 'term': 'RG-1507 monoclonal antibody'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], '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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2008-12-18', 'studyFirstSubmitQcDate': '2008-12-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, laboratory parameters, vital signs', 'timeFrame': 'Throughout study'}], 'secondaryOutcomes': [{'measure': 'Trough levels of R1507', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* malignant neoplasms;\n* failed prior standard curative therapy;\n* ECOG performance Status of 0 or 1;\n* adequate bone marrow, hepatic and renal function;\n* life expectancy greater than 8 weeks.\n\nExclusion Criteria:\n\n* chemotherapy within 2 weeks of start of therapy;\n* prior irradiation within 4 weeks prior to start of therapy;\n* prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;\n* major surgery or significant traumatic injury within 2 weeks prior to study start;\n* patients receiving concurrent antibody or immunotherapy;\n* other exclusion criteria are related to specific treatment regimens.'}, 'identificationModule': {'nctId': 'NCT00811993', 'briefTitle': 'A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'NO22068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: RG1507', 'Drug: erlotinib [Tarceva]', 'Drug: gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': '10', 'interventionNames': ['Drug: RG1507', 'Drug: temozolomide']}, {'type': 'EXPERIMENTAL', 'label': '11', 'interventionNames': ['Drug: RG1507', 'Drug: bevacizumab [Avastin]', 'Drug: docetaxel']}, {'type': 'EXPERIMENTAL', 'label': '12', 'interventionNames': ['Drug: RG1507', 'Drug: pemetrexel']}, {'type': 'EXPERIMENTAL', 'label': '13', 'interventionNames': ['Drug: RO1507']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: RG1507', 'Drug: bevacizumab [Avastin]', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: RG1507', 'Drug: carboplatin', 'Drug: etoposide']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: RG1507', 'Drug: bevacizumab [Avastin]', 'Drug: mFOLFOX6']}, {'type': 'EXPERIMENTAL', 'label': '5', 'interventionNames': ['Drug: RG1507', 'Drug: capecitabine [Xeloda]', 'Drug: trastuzumab [Herceptin]']}, {'type': 'EXPERIMENTAL', 'label': '6', 'interventionNames': ['Drug: RG1507', 'Drug: sorafenib']}, {'type': 'EXPERIMENTAL', 'label': '7', 'interventionNames': ['Drug: RG1507', 'Drug: bevacizumab [Avastin]', 'Drug: erlotinib [Tarceva]']}, {'type': 'EXPERIMENTAL', 'label': '8', 'interventionNames': ['Drug: RG1507', 'Drug: cetuximab', 'Drug: irinotecan']}, {'type': 'EXPERIMENTAL', 'label': '9', 'interventionNames': ['Drug: RG1507', 'Drug: bevacizumab [Avastin]', 'Drug: carboplatin', 'Drug: paclitaxel']}], 'interventions': [{'name': 'RG1507', 'type': 'DRUG', 'description': 'Starting dose of \\>=3mg/kg iv escalating to a maximum dose of \\<=16mg/kg iv, depending on dosing schedule in each combination treatment arm', 'armGroupLabels': ['1', '10', '11', '12', '2', '3', '4', '5', '6', '7', '8', '9']}, {'name': 'RO1507', 'type': 'DRUG', 'description': '27mg/kg iv, monotherapy', 'armGroupLabels': ['13']}, {'name': 'bevacizumab [Avastin]', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['11', '2', '4', '7', '9']}, {'name': 'capecitabine [Xeloda]', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['5']}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['3', '9']}, {'name': 'cetuximab', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['8']}, {'name': 'docetaxel', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['11']}, {'name': 'erlotinib [Tarceva]', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['1', '7']}, {'name': 'etoposide', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['3']}, {'name': 'gemcitabine', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['1']}, {'name': 'irinotecan', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['8']}, {'name': 'mFOLFOX6', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['4']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['2', '9']}, {'name': 'pemetrexel', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['12']}, {'name': 'sorafenib', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['6']}, {'name': 'temozolomide', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['10']}, {'name': 'trastuzumab [Herceptin]', 'type': 'DRUG', 'description': 'as prescribed', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90025', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}