February 2009 US clinical trial update

United States

Imatinib + Bevacizumab Phase III: Over 210 Coalition of Cancer Cooperative Groups (CCOP) sites are now recruiting. Please use www.clinicaltrials .gov or cancertrialshelp.org for more detailed site contact information.

Masitinib Phase III: This is a new US and international Phase III trial, more details can be found in Jerry Call’s article on page 1.

IPI-504 Phase III: New trial sites have been added in Aurora Colo., Washington DC, Miami Beach, Flor., Chicago Ill., and New York, N.Y.

BIIB021 Phase II: Inclusion criteria have been expanded.

Dasatinib Phase II: A new site has been added at the University of Iowa in Iowa City, Iowa.

Trials listed as “Ongoing but not recruiting: Imatinib + Pegylated Interferon-1 2B Phase II; Perifosine + Imatinib Phase II; XL820 Phase II; OSI-930 Phase I. Exelixis has informed us that the XL820 trial is closed. We will continue to follow these trials in the LRG database.

LBH589 Phase I: The trial may now be primarily for breast cancer patients so we have dropped the listing for the newsletter but will continue to cover it in the LRG database.

CNF2024 Phase I: This trial has been is listed as “completed”. This usually means that data collection has been completed. We will continue to follow this trial in the LRG database.

BAY73-4506 Phase 1: (New Trial) This is a multi-targeted kinase inhibitor that blocks tumor growth through multiple targets (i.e. Raf-1, BRAF, VEGFR 2/3, c-kit, PDGFR, and FGFR-1).

PX478 Phase 1: (NT) This drug is an oral HIF-1α Inhibitor. This type of inhibitor may have activity against certain pediatric type GISTs with defects in the SDH gene(s). These types include Carney Stratakis syndrome and possible Carney's Triad.

R1507 Phase 1: (NT) R1507 is a human monoclonal antibody and an inhibitor of IGF-1R.

Sorafenib + Vorinostat Phase 1: (NT) This trial combines a broad spectrum c-KIT plus inhibitor Sorafenib (Nexavar) with a Histone Deacytelase (HDAC) inhibitor Vorinostat (Zolinza). This combination has been shown effective against CML cell lines in the lab.

Sunitinib + CP-751,871 Phase 1: (NT) This phase I trial combines a potent KIT inhibitor (Sutent) with an IGF-1R inhibitor. This combination might be especially appropriate for wild-type GIST since Sutent is a potent inhibitor of wildtype KIT and since IGF-1R is overexpressed in wild-type GIST.

International

Imatinib or Sunitinib Phase III: New recruiting sites have been added in the United Kingdom and Germany.

To view the latest clinical trials, visit: http://www.liferaftgroup.org/treat_trials.html