Status:
COMPLETED
A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by objective response rate (ORR). Secondary Objective: To assess the following: * safety...
Detailed Description
Screening was up to 24 days. Treatment period was continued until DP, unacceptable toxicity, or participant's refusal. Follow up period was continued until death, participant's refusal, or end of stud...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically or cytologically proven adenocarcinoma of the colon or rectum.
- Metastatic disease that was not amenable to potentially curative treatment.
- Participants with measurable disease.
- One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease.
- Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy were also eligible.
- Exclusion criteria:
- Prior therapy with irinotecan.
- Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior chemotherapy to the time of registration.
- Unresolved toxicity (grade \>1) from prior anticancer therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status \>1.
- Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis.
- Other prior malignancy.
- Pregnant or breast-feeding women.
- Uncontrolled hypertension.
- Inadequate bone marrow function, liver function, or renal function.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01882868
Start Date
July 1 2013
End Date
August 1 2015
Last Update
March 14 2017
Active Locations (19)
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1
Investigational Site Number 392011
Chiba, Japan
2
Investigational Site Number 392018
Chūōku, Japan
3
Investigational Site Number 392016
Fukuoka, Japan
4
Investigational Site Number 392017
Fukuoka, Japan