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

This study is currently recruiting participants.
Verified by Biogen Idec, February 2008

Sponsored by: 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

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Sunitinib    Sunitinib malate    Imatinib    Imatinib mesylate    Fluorodeoxyglucose F18   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment
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

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 ]

Estimated Enrollment:   60
Study Start Date:   February 2008
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  • ECOG performance status of less than or equal to 2.
  • Required laboratory values:

    • Absolute neutrophil count (ANC) greater than or equal to 1500 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, hemoglobin greater than or equal to 9 gm/L.
    • Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than or equal to 2.5 x ULN; except in subjects with known hepatic metastasis, where AST or ALT can be less than or equal to 5.0 x ULN.
    • Serum creatinine less than or equal to 2.0 x ULN.
    • International Normalized Ratio (INR) less than or equal to 1.5 x ULN.
    • All other values less than or equal to NCI CTCAE Grade 1.
  • Female subjects of childbearing potential must have a negative pregnancy test during screening.
  • Male and female subjects of childbearing potential must practice effective double barrier contraception during the study and continue contraception for 3 months after their last dose of study drug.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Prior treatment with imatinib, sunitinib, or sorafenib within 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, and sorafenib) and biologics, or radiotherapy within 28 days or <3 half lives (whichever is longer) before start of BIIB021 treatment.
  • Diabetes and/or concurrent severe or uncontrolled other medical disease (i.e., systemic infection, hypertension, coronary artery disease, congestive heart failure).
  • Active symptomatic fungal, bacterial, and/or viral infection including active HIV or viral (A, B, or C) hepatitis.
  • Problems with swallowing or malabsorption.
  • Chronic diarrhea (excess of 2 to 3 stools/day above normal frequency).
  • Inflammatory gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
  • Major surgery within 28 days of first administration of study treatment.
  • Active or untreated brain metastasis.
  Contacts and Locations

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

Contacts
Contact: Biogen Idec     oncologyclinicaltrials@biogenidec.com    

Locations
United States, Minnesota
Research Site     Not yet recruiting
      Rochester, Minnesota, United States
United States, New York
Research Site     Recruiting
      New York, New York, United States

Sponsors and Collaborators
Biogen Idec
  More Information


Responsible Party:   Biogen Idec ( Biogen Idec MD )
Study ID Numbers:   120GS201
First Received:   February 8, 2008
Last Updated:   March 18, 2008
ClinicalTrials.gov Identifier:   NCT00618319
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Imatinib
Digestive System Diseases
Digestive System Neoplasms
Sunitinib
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 17, 2008




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