An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin
Phase 2
Completed
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00165867
- Lead Sponsor
- Eisai Limited
- Brief Summary
The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The objective response rate as defined by RECIST criteria.
- Secondary Outcome Measures
Name Time Method Duration of response time to progression overall survival safety and tolerability of the combination
Trial Locations
- Locations (7)
Cookridge Hospital
🇬🇧Leeds, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Hôpitaux Civils de Colmar
🇫🇷Colmar, France
CRLC Val d'Aurelle
🇫🇷Montpellier, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, United Kingdom