An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) - Tabular View

Tracking Information

First Received Date ^ICMJE

February 8, 2008

Last Updated Date

July 14, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in FDG-PET imaging [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00618319 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Characterize the safety profile of BIIB021 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)

Official Title ^ICMJE

An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not a Candidate for Imatinib and Sunitinib Treatment

Brief Summary

This study will examine the effect of BIIB021 on GIST growth and metabolism.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

GIST

Intervention ^ICMJE

Drug: BIIB021

Study Arms / Comparison Groups

Experimental: BIIB021

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
Age greater than or equal to 18 years at the time of informed consent.
Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy.
FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening.
ECOG performance status of less than or equal to 2.
Lab values consistent with adequate renal hepatic and bone marrow function.
Must utilize effective contraception.

Exclusion Criteria:

Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day 1.
Prior treatment with Hsp90 inhibitors at any time.
Prior antitumor therapies including prior experimental agents, approved antitumor small molecules (excluding imatinib, sunitinib, or sorafenib) and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer) before start of BIIB021treatment.
Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure).
History of/ or predisposition to seizures.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Biogen Idec

oncologyclinicaltrials@biogenidec.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00618319

Responsible Party

Biogen Idec MD, Biogen Idec

Study ID Numbers ^ICMJE

120GS201

Study Sponsor ^ICMJE

Biogen Idec

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Biogen Idec

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP