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Dose-Escalation Study in Advanced Colon Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969046
First Posted: August 31, 2009
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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 Intervention Phase
Colon Cancer Drug: EPO906 (patupilone) Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 60
Study Start Date: November 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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


Locations
Czech Republic
Novartis Investigative Site
Hradec Králové, Czech Republic
Novartis Investigative Site
Prague, Czech Republic
France
Novartis Investigative Site
Saint-Herblain Cedex, France
Novartis Investigative Site
Toulouse, France
Spain
Novartis Investigative Site
Barcelona, Spain
United Kingdom
Novartis Investigative Site
London, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Royal London Hospital
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00969046     History of Changes
Other Study ID Numbers: CEPO906A2117
First Submitted: August 10, 2009
First Posted: August 31, 2009
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Colon cancer
MTD
DLT
EPO906
patupilone

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Epothilone B
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action