Dose-Escalation Study in Advanced Colon Cancer Patients

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: 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 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 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