Dose-Escalation Study in Advanced Colon Cancer Patients

NCT ID: NCT00969046

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Keywords

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Colon cancer MTD DLT EPO906 patupilone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bolus

20 min bolus infusion

Group Type EXPERIMENTAL

EPO906 (patupilone)

Intervention Type DRUG

CIV-1d

1 day continuous infusion

Group Type EXPERIMENTAL

EPO906 (patupilone)

Intervention Type DRUG

CIV-5d

5 day continuous infusion

Group Type EXPERIMENTAL

EPO906 (patupilone)

Intervention Type DRUG

Interventions

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EPO906 (patupilone)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Royal London Hospital

Locations

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Novartis Investigative Site

Hradec Králové, , Czechia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Saint-Herblain, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Countries

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Czechia France Spain United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2945

Results for CEPO906A2117 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CEPO906A2117

Identifier Type: -

Identifier Source: org_study_id