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Dose-Escalation Study in Advanced Colon Cancer Patients

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ClinicalTrials.gov Identifier: NCT00969046
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : December 8, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: EPO906 (patupilone) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2003
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Arm Intervention/treatment
Experimental: Bolus
20 min bolus infusion
Drug: EPO906 (patupilone)
Experimental: CIV-1d
1 day continuous infusion
Drug: EPO906 (patupilone)
Experimental: CIV-5d
5 day continuous infusion
Drug: EPO906 (patupilone)

Primary Outcome Measures :
  1. To identifymaximum tolerated dose (MTD) [ Time Frame: During cycle 1 and 2 (approx 6 to 8 wks) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969046

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Novartis Investigative Site
Hradec Králové, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Saint-Herblain Cedex, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Barcelona, Spain
United Kingdom
Novartis Investigative Site
London, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Royal London Hospital
Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00969046    
Other Study ID Numbers: CEPO906A2117
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: April 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Colon cancer
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Epothilone B
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action