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Dose-Escalation Study in Advanced Colon Cancer Patients

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EPO906 (patupilone)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Colon cancer, MTD, DLT, EPO906, patupilone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Bolus

CIV-1d

CIV-5d

Arm Description

20 min bolus infusion

1 day continuous infusion

5 day continuous infusion

Outcomes

Primary Outcome Measures

To identifymaximum tolerated dose (MTD)

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
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])
To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration

Full Information

First Posted
August 10, 2009
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00969046
Brief Title
Dose-Escalation Study in Advanced Colon Cancer Patients
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colon cancer, MTD, DLT, EPO906, patupilone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bolus
Arm Type
Experimental
Arm Description
20 min bolus infusion
Arm Title
CIV-1d
Arm Type
Experimental
Arm Description
1 day continuous infusion
Arm Title
CIV-5d
Arm Type
Experimental
Arm Description
5 day continuous infusion
Intervention Type
Drug
Intervention Name(s)
EPO906 (patupilone)
Primary Outcome Measure Information:
Title
To identifymaximum tolerated dose (MTD)
Time Frame
During cycle 1 and 2 (approx 6 to 8 wks)
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Royal London Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Hradec Králové
Country
Czechia
Facility Name
Novartis Investigative Site
City
Prague
Country
Czechia
Facility Name
Novartis Investigative Site
City
Saint-Herblain Cedex
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
Country
France
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2945
Description
Results for CEPO906A2117 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Dose-Escalation Study in Advanced Colon Cancer Patients

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