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Phase II Trial of RAD001 in Refractory Colorectal Cancer

NCT ID: NCT00337545

Last Updated: 2007-10-10

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

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-04-30

Brief Summary

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Single center open-label study of an oral agent (RAD001) in subjects with metastatic colorectal cancer refractory to at least 2 standard chemo/biologic regimens.

Detailed Description

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Study is completed and closed.

Conditions

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Colorectal Cancer

Keywords

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Metastatic Refractory

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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RAD001

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Metastatic colorectal cancer refractory to at least 2 chemo/biologic regimens
* Measurable disease
* ECOG 0-2

Exclusion Criteria

* CNS disease
* Chemotherapy or radiotherapy \< 4 weeks prior
* Active bleeding diathesis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Swedish Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Philip Gold, M.D.

Role: PRINCIPAL_INVESTIGATOR

Swedish Cancer Institute

Locations

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Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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Swedish Cancer Institute 05128

Identifier Type: -

Identifier Source: secondary_id

CRAD0012467

Identifier Type: -

Identifier Source: org_study_id