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

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

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

Study Overview

• Status: Completed
• Conditions: GIST
• Intervention / Treatment: Drug: BIIB021

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States
      • Reseach Facility
    • Santa Monica, California, United States, 90404
      • Research Site
  • Texas
    • San Antonio, Texas, United States
      • Reseach Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; BIIB021	Drug: BIIB021; Dose, schedule, and duration specified in protocol; Other Names: CNF2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in FDG-PET imaging	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize the safety profile of BIIB021	Duration of study

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: February 8, 2008
• First Submitted That Met QC Criteria: February 8, 2008
• First Posted (ESTIMATE): February 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 2, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors
• Other Study ID Numbers: 120GS201