Description:
A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to
bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of
the colon or rectum.
Title
- Brief Title: A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
M14-064
- SECONDARY ID:
2017-003669-87
- NCT ID:
NCT03368859
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Leucovorin | Folinic Acid | ABT-165 plus FOLFIRI |
Fluorouracil - bolus | 5-FU | ABT-165 plus FOLFIRI |
Bevacizumab | Avastin | Bevacizumab plus FOLFIRI |
Fluorouracil - infusion | 5-FU | ABT-165 plus FOLFIRI |
ABT-165 | | ABT-165 plus FOLFIRI |
Irinotecan | Irinotecan hydrochloride | ABT-165 plus FOLFIRI |
Purpose
A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to
bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of
the colon or rectum.
Trial Arms
Name | Type | Description | Interventions |
---|
ABT-165 plus FOLFIRI | Experimental | ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil). | - Leucovorin
- Fluorouracil - bolus
- Fluorouracil - infusion
- ABT-165
- Irinotecan
|
Bevacizumab plus FOLFIRI | Active Comparator | Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil). | - Leucovorin
- Fluorouracil - bolus
- Bevacizumab
- Fluorouracil - infusion
- Irinotecan
|
Eligibility Criteria
Inclusion 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause. |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively |
Safety Issue: | |
Description: | ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. |
Measure: | Overall Survival (OS) |
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 |
Safety Issue: | |
Description: | OS is defined as the time from randomization until death from any cause. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | AbbVie |
Trial Keywords
- cancer
- colorectal cancer
- ABT-165
- FOLFIRI
- Bevacizumab
- bowel cancer
- metastatic colorectal cancer
- metastatic colorectal
Last Updated
February 9, 2021