Clinical trial · Interventional
Dose-Escalation Study in Advanced Colon Cancer Patients
EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
NCT00969046CI-TRIAL-00048712completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EPO906 (patupilone) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Bolus
- description
- 20 min bolus infusion
- interventionNames
- Drug: EPO906 (patupilone)
- type
- EXPERIMENTAL
- label
- CIV-1d
- description
- 1 day continuous infusion
- interventionNames
- Drug: EPO906 (patupilone)
- type
- EXPERIMENTAL
- label
- CIV-5d
- description
- 5 day continuous infusion
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.