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

GIST Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618319
• Other study ID #: 120GS201
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2008
• Last updated: September 17, 2015
• Start date: February 2008
• Est. completion date: April 2010

Study information

• Verified date: March 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• GIST

Intervention

Drug:
• BIIB021
Dose, schedule, and duration specified in protocol

Locations

Country	Name	City	State
United States	Reseach Facility	Encinitas	California
United States	Reseach Facility	San Antonio	Texas
United States	Research Site	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in FDG-PET imaging		28 days	No
Secondary	Characterize the safety profile of BIIB021		Duration of study	No