Status:
COMPLETED
Dose-Escalation Study in Advanced Colon Cancer Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced co...
Eligibility Criteria
Inclusion
- Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST
- Age ≥ 18 years
- Life expectancy ≥ 12 weeks
- WHO performance status of 0-1
- Negative serum pregnancy test
- Adequate hepatic or renal function and hematological parameters
Exclusion
- Brain metastases
- Ileostomy or colonostomy
- History of pelvic radiotherapy
- Grade \> 1 diarrhea at baseline
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00969046
Start Date
November 1 2003
End Date
November 1 2006
Last Update
December 8 2020
Active Locations (6)
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1
Novartis Investigative Site
Hradec Králové, Czechia
2
Novartis Investigative Site
Prague, Czechia
3
Novartis Investigative Site
Saint-Herblain, France
4
Novartis Investigative Site
Toulouse, France