NCT00337545

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

June 15, 2006

Last Update Submit

October 5, 2007

Conditions

Colorectal Cancer

Keywords

MetastaticRefractory

Interventions

RAD001DRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • CNS disease
  • Chemotherapy or radiotherapy \< 4 weeks prior
  • Active bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Philip Gold, M.D.

    Swedish Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 16, 2006

Study Start

May 1, 2006

Study Completion

April 1, 2007

Last Updated

October 10, 2007

Record last verified: 2007-10

Locations

US(1)