Dose-Escalation Study in Advanced Colon Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: EPO906 (patupilone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Brain metastases Ileostomy or colonostomy History of pelvic radiotherapy Grade > 1 diarrhea at baseline Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus<br>20 min bolus infusion | Drug: EPO906 (patupilone)<br> <br> |
| Experimental: CIV-1d<br>1 day continuous infusion | Drug: EPO906 (patupilone)<br> <br> |
| Experimental: CIV-5d<br>5 day continuous infusion | Drug: EPO906 (patupilone)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identifymaximum tolerated dose (MTD) |  | During cycle 1 and 2 (approx 6 to 8 wks) | 

Secondary Outcome Measures

| Outcome Measure | 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]) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon cancer, MTD, DLT, EPO906, patupilone