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

This study has been completed.

First Received on February 8, 2008. Last Updated on March 17, 2011 History of Changes

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00618319

Purpose

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

Condition	Intervention	Phase
GIST	Drug: BIIB021	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	20
Study Start Date:	February 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 BIIB021	Drug: BIIB021 Dose, schedule, and duration specified in protocol Other Name: CNF2024

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618319

Locations

United States, Minnesota
Research Site
Rochester, Minnesota, United States
United States, New York
Research Site
New York, New York, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00618319 History of Changes
Other Study ID Numbers:	120GS201
Study First Received:	February 8, 2008
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012