Ph2 study of chemotherapy plus ABT-165 compared to chemotherapy plus bevacizumab in people with metastatic colorectal (bowel) cancer
- Conditions
- metastatic adenocarcinoma of the colon or rectum previously treated with a regimen containing fluoropyrimidine/oxaliplatin and bevacizumabTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003669-87-BE
- Lead Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- At least 1 lesion on a computed tomography (CT) scan that is measurable as defined by RECIST, Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Progression following treatment with fluoropyrimidine(fluorouracil, capecitabine or tegafur)/oxaliplatin/bevacizumab-regimen in the metastatic setting
- Adequate hematologic, renal and hepatic function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
- Any prior therapy with irinotecan
- No unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) = Grade 2
- No active clinically significant condition(s) that might put the subject at higher risk for anti-angiogenic therapy
- Prior history of clinically significant: pulmonary hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic heart failure (Heart Association class III – IV), cardiomyopathy, myocardial infarction, unstable/severe angina pectoris, active cardiac arrhythmia, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, cerebrovascular accident or transient ischemic attack within 1 year of randomization.
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the progression-free survival (PFS) of ABT-165 plus irinotecan, fluorouracil and leucovorin chemotherapy regimen (FOLFIRI) compared to bevacizumab plus FOLFIRI, as assessed by blinded independent central review, in subjects with previously treated mCRC who have received a regimen containing fluoropyrimidine, oxaliplatin, and bevacizumab.;Secondary Objective: To assess overall survial (OS), objective response rate (ORR), safety, and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI.;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: From the time of randomization to the first occurrence of radiographic progression during the treatment or follow-up period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): overall suvival (OS), objective response rate (ORR) and Safety ;Timepoint(s) of evaluation of this end point: OS: from randomization until death from any cause during the treatment or follow-up period<br>ORR: up to 30 days after a 24-month treatment period<br>Safety: up to 90 days after a 24-month treatment period