Phase II Trial of RAD001 in Refractory Colorectal Cancer | NCT00337545

Studies
Phase II Trial of RAD001 in Refractory Colorectal Cancer

NCT00337545

Sponsor

Swedish Medical Center

Status

Completed

Last Update Posted

Oct 10, 2007Estimated

Enrollment

22Actual

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

RAD001

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Swedish Cancer Institute 05128

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007

First Submitted Date

Jun 15, 2006

First Submission Date that Met QC Criteria

Jun 15, 2006

First Posted Date

Jun 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2007

Last Update Posted Date

Oct 10, 2007Estimated

Name	Class
Novartis	INDUSTRY

Description Module

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.

Detailed Description

Study is completed and closed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Name	Type	Description	Arm Group Labels	Other Names
RAD001	Drug

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Gold, M.D.	Swedish Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swedish Cancer Institute		Seattle	Washington	98104	United States

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068338	Everolimus

Ancestor Terms

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided