NCT00969046

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2003

Typical duration for phase_1

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
Last Updated

December 8, 2020

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

August 10, 2009

Last Update Submit

December 6, 2020

Conditions

Colon Cancer

Keywords

Colon cancerMTDDLTEPO906patupilone

Outcome Measures

Primary Outcomes (1)

  • To identifymaximum tolerated dose (MTD)

    During cycle 1 and 2 (approx 6 to 8 wks)

Secondary Outcomes (3)

  • 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

    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])

    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

    Cycle 1 and 4

Study Arms (3)

Bolus

EXPERIMENTAL

20 min bolus infusion

Drug: EPO906 (patupilone)

CIV-1d

EXPERIMENTAL

1 day continuous infusion

Drug: EPO906 (patupilone)

CIV-5d

EXPERIMENTAL

5 day continuous infusion

Drug: EPO906 (patupilone)

Interventions

EPO906 (patupilone)DRUG
BolusCIV-1dCIV-5d

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Brain metastases
  • Ileostomy or colonostomy
  • History of pelvic radiotherapy
  • Grade \> 1 diarrhea at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

Hradec Králové, Czechia

Location

Novartis Investigative Site

Prague, Czechia

Location

Novartis Investigative Site

Saint-Herblain, France

Location

Novartis Investigative Site

Toulouse, France

Location

Novartis Investigative Site

Barcelona, Spain

Location

Novartis Investigative Site

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Novartis Pharmaceuticals

    Royal London Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 31, 2009

Study Start

November 1, 2003

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 8, 2020

Record last verified: 2016-04

Locations

CZ(2)GB(1)FR(2)ES(1)