Clinical Trials List
2018-03-01 - 2020-06-16
Phase II
Terminated3
ICD-10C18.9
Malignant neoplasm of colon, unspecified
ICD-10C7A.029
Malignant carcinoid tumor of the large intestine, unspecified portion
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9153.9
Malignant neoplasm of colon, unspecified
Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Kang-Ling Wang Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- CHOU-CHEN CHEN Division of Colorectal Surgery
- 邵彥誠 Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 黃約翰 Division of Colorectal Surgery
- Been Ren Lin Division of Colorectal Surgery
- 洪基翔 Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Progression Free Survival (PFS) [ Time Frame: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively ]
PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
Inclution Criteria
-Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
--Primary tumor has been resected > 3 months prior to randomization.
-At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1.
-Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
-Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.
-Adequate hematologic, renal and hepatic function.
Exclusion Criteria
-Any prior therapy with irinotecan
-Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
-Clinically significant conditions that increase the risk for antiangiogenic therapy.
-History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
100 participants
