Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00801294
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2008-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}, {'id': 'D000077716', 'term': 'Afatinib'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'lastUpdateSubmitDate': '2017-12-28', 'studyFirstSubmitDate': '2008-12-02', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks', 'timeFrame': 'every 4 weeks'}, {'measure': 'PFS', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (based on the RECIST criteria)', 'timeFrame': '66 Weeks'}, {'measure': 'Overall survival', 'timeFrame': '66 Weeks'}, {'measure': 'The incidence and intensity of Adverse Events with grading of Adverse Events according to the US NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0)', 'timeFrame': '66 Weeks'}, {'measure': 'Changes in safety laboratory parameters', 'timeFrame': '66 Weeks'}, {'measure': 'Effectiveness of dose reduction guidelines in managing adverse events', 'timeFrame': '66 Weeks'}]}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/21737652', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age over 18 years.\n2. Signed informed consent.\n3. Histologically proven colorectal adenocarcinoma\n4. History or presence of metastatic colorectal cancer (stage IV)\n5. Measurable (\\>1 cm) or evaluable tumour deposit (according to RECIST criteria)\n6. Documented progression or unacceptable toxicity on the last therapy\n7. Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin\n8. Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan\n9. If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity\n10. If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity\n11. Life expectancy of at least 12 weeks.\n12. WHO (ECOG) performance status \\<= 2, \\<= 1 if age \\> 75 years.\n13. Adequate hepatic function\n14. Adequate renal function\n\nExclusion Criteria:\n\n1. Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors\n2. Treatment with standard chemotherapy or cetuximab within the last 14 days\n3. Treatment with bevacizumab within the last 28 days\n4. History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.\n5. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality\n6. Significant cardiovascular diseases\n7. History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.\n8. Patient with history or clinical or radiological evidence of CNS disease or brain metastases.\n9. Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00801294', 'briefTitle': 'A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer', 'orgStudyIdInfo': {'id': '1239.2'}, 'secondaryIdInfos': [{'id': 'EudraCT 2006-000893-56'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'BIBF 1120 and BIBW 2992', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': '1239.2.3305A clinique Saint Jean', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': '1239.2.3305B Cabinet Médical', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301A Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301B Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301C Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301D Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301E Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301F Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301G Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301H Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301I Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301J Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3301K Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3302A Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1239.2.3302B Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Reims', 'country': 'France', 'facility': '1239.2.3304A Hôpital Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Reims', 'country': 'France', 'facility': '1239.2.3304B Hôpital Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Reims', 'country': 'France', 'facility': '1239.2.3304C Hôpital Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Villejuif', 'country': 'France', 'facility': '1239.2.3303A Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Villejuif', 'country': 'France', 'facility': '1239.2.3303B Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Villejuif', 'country': 'France', 'facility': '1239.2.3303C Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Villejuif', 'country': 'France', 'facility': '1239.2.3303D Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Villejuif', 'country': 'France', 'facility': '1239.2.3303E Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Villejuif', 'country': 'France', 'facility': '1239.2.3303F Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}