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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 January 2021 |
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Main ID: |
NCT00969046 |
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Date of registration:
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10/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose-Escalation Study in Advanced Colon Cancer Patients
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Scientific 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 |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00969046 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Czech Republic
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Czechia
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France
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Spain
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United Kingdom
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal London Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colon Cancer
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Intervention(s)
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Drug: EPO906 (patupilone)
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Primary Outcome(s)
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To identifymaximum tolerated dose (MTD)
[Time Frame: During cycle 1 and 2 (approx 6 to 8 wks)]
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Secondary Outcome(s)
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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
[Time Frame: at base line, every 3 weeks prior to start of the next dose, at end of treatment]
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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])
[Time Frame: at baseline and every 8 wks]
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To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration
[Time Frame: Cycle 1 and 4]
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Secondary ID(s)
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CEPO906A2117
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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