Overview
Dose-Escalation Study in Advanced Colon Cancer Patients
Status:
Completed
Completed
Trial end date:
2006-11-01
2006-11-01
Target enrollment:
0
0
Participant gender:
All
All
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 colon cancer.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
Epothilone B
Criteria
Inclusion Criteria:1. 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
2. Age ≥ 18 years
3. Life expectancy ≥ 12 weeks
4. WHO performance status of 0-1
5. Negative serum pregnancy test
6. Adequate hepatic or renal function and hematological parameters
Exclusion Criteria:
1. Brain metastases
2. Ileostomy or colonostomy
3. History of pelvic radiotherapy
4. Grade > 1 diarrhea at baseline
Other protocol-defined inclusion/exclusion criteria may apply