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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus | Experimental | 20 min bolus infusion |
|
| CIV-1d | Experimental | 1 day continuous infusion |
|
| CIV-5d | Experimental | 5 day continuous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPO906 (patupilone) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To identifymaximum tolerated dose (MTD) | During cycle 1 and 2 (approx 6 to 8 wks) |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety and tolerability of patupilone by assessing adverse events (AEs) and serious adverse events (SAEs), hematology and biochemistry labs, vital signs, performance status, and by physical/neurological exams | at base line, every 3 weeks prior to start of the next dose, at end of treatment | |
| To evaluate preliminary anti-tumor activity of patupilone using standard imaging technologies (e.g. best overall response rate and time to progression according to Response Evaluation Criteria in Solid Tumors [RECIST]) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Royal London Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hradec Králové | Czechia | ||||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CEPO906A2117 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C093788 | epothilone B |
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| at baseline and every 8 wks |
| To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration | Cycle 1 and 4 |
| Prague |
| Czechia |
| Novartis Investigative Site | Saint-Herblain | France |
| Novartis Investigative Site | Toulouse | France |
| Novartis Investigative Site | Barcelona | Spain |
| Novartis Investigative Site | London | United Kingdom |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |