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Dose-Escalation Study in Advanced Colon Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00969046
First received: August 10, 2009
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  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: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

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

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2003
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00969046     History of Changes
Other Study ID Numbers: CEPO906A2117
Study First Received: August 10, 2009
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013