GIST Support Wiki4 Mar 2008
Subject: For Wiki-Mon, Phase II trial for GIST: HSP90 Inhibitor BIIB021
Marina writes:
The trial sites include NYC (I assume MSKCC) and Rochester MN (I assume the Mayo clinic). Contact is through the trial sponsor, Biogen: oncologyclinicaltrials@biogenidec.com
Biogen has a HSP90 drug called CNF2024. I DO NOT KNOW if BIIB021 is a different drug than CNF2024???? Don't know, but I bring it up because Herb Flom tried CNF2024 and Kathy wrote about it in the Wiki. There many different intestigational HSP90 inhibitors out there. HSP90 is a very drug-able target. Some inhibitors are based on the antibiotic geldanamycin, and others are smaller synthetic molecules that mimic the shape and chemical characteristics of the ATP binding pocket on HSP90.
For the new people, HSP90 is a chaperone that facilitates the actions of mutated KIT in GIST. When HSP90 is blocked by an inhibiting drug, then the mutated KIT proteins in GIST are destroyed at a faster rate...
More on geldanamycin: http://geldanamycin.info/index.htm
http://clinicaltrials.gov/ct2/show/NCT00618319
FDG-PET Pharmacodynamic Assessment of BIIB021 in 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
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
[edit] Comments from Trial Participants
[edit] Dave B
Dave was formerly on Nilotinib (AMN107/Tasigna) and Sorafenib (Nexavar) - see corresponding pages
4 Mar 2008
Marina,
I'm going to participate in this trial. The insurance cleared and MSKCC is setting up my pre-tests.
You're right on all counts- It is at both MSKCC and the Mayo Clinic. It is CNF2024, renamed after Biogen Idec bought out the prior drug company.
It's a PET Scan intensive trial.
Dave
21 Apr 2008
Kerry,
The metasteses from GIST can go pretty much anywhere as the disease advances. I'm finishing up a 10 day regimen of radiation for several sites in and/or on my back muscles and bones. There are also sites in my lungs. I have about a half dozen sites in my leg muscles, both calf and thigh, and one that I can feel and move around with my fingers on my left shoulder. None of the leg or shoulder sites bother me but they're easy to see on CAT and PET scans.
I was in a trial at Fox Chase for AMN 107 and it didn't do anything for me either.
Nexavar is pretty nasty stuff. It gave me high blood pressure, lowered my appetite, I lost weight quickly, developed thick callouses on the soles of my feet and had very serious bouts of diarrhea. I'm surprised the insurance company has a problem with a prescription for it since it's FDA approved for kidney cancer. You're just getting it off-label.
I'll be returning to MSKCC for a phase 2 trial of BIIB021, (NCT00618319 Clinical.trials.gov identifier) in 2 weeks. They insisted that I get the back sites irradiated before I could start the trial.
I hope this helps, Good luck with your husbands fight.
Dave