My name is Jim. I like to spend time with my wife Lori and I love to play golf.

March 2007 clinical trial update

By Jim Hughes
Member of LRG Science Team

In this month’s newsletter, you will find a new format for reporting clinical trials. We hope that this method is easier for the reader to track clinical trials.

Two New Tables:

1. Drug Names Table:

This reference is intended to track the different names of GIST drugs.

When first introduced a new drug or Investigational New Drug (IND) is given an alphanumeric designation that is often a combination of an abbreviation of the manufacturers name and a number representing a compound of interest. In the case of Gleevec, the original name was STI-571. STI for “Signal Transduction Inhibitor” and “571” for the compound number being tested.

The International Non-proprietary Name (INN) is assigned by the World Health Organization (WHO) when a manufacturer applies for a generic name for a new compound. The WHO has a scheme whereby the active part of the drug is classified and given a “stem” as part of the name. Stems used in the GIST world include:
• “tinib” refer to a tyrosine kinase inhibitor.
• “anib” refers to an angiogenesis inhibitor.
• “mycins” are antibiotics.
• “imus’ refers to immunosuppressants.

INN’s are also referred to as “generic” drug names.

The Proprietary Name is the trademarked name chosen by the drug company for marketing the drug. Different drug companies will have different names for the same INN compound.

The strategy is a broad category intended to group drugs that have a similar target. It is important to note that while drugs target some component of GIST viability, they often can have effects beyond GIST. The rash that can accompany Gleevec usage may be a result of Gleevec’s effect on normal mast cells. It is also worth noting that cell signalling is a highly complex and interactive environment. They say there is a lot of “cross-talk.” The effect of a single drug sometimes may come from a mechanism not originally targeted. As an example, it has recently been reported that Gleevec can positively affect the immune system response to GIST!

It has been suggested that GIST therapy may eventually involve a combination of targeted drugs. Newer GIST drugs and trials use a combination of strategies. Drugs like Sutent incorporate multiple strategies. Some new drug trials may also incorporate a combination of multi-acting drugs. The drug table lists some of the specific targets included in each strategy.

The drug names table is sorted first by strategy and then by IND name within a strategy.

2. Clinical Trial Table:

The new clinical trial table is designed to make it easier to find and compare GIST clinical trials.

The “Therapy” column takes the name of the trial drug being tested directly from the published trial description (sometimes it is the older IND name).

The “Title” column contains the short description of the trial found at the clinicaltrials. gov website.

The “Trial #” column contains the published numeric designation for a trial. Usually this is the NCT number assigned when the trial is listed on the clinicaltrials.gov website. When contacting a clinical trial site patients are asked to refer to this number to identify the trial. In practice, most trial sites will know the trial by the title.

The Phase column identifies the phase of the trial. Some trials are listed as combined phase I and phase II trials. The phase is taken from the published trial description.

The “For” column contains the indication or condition published in the trial description. This will be the conditions in the clinicaltrials.gov listing or the condition described in the trial title for trials not in the clinicaltrials.gov website.

U.S. Locations and Contacts: For trials in the United States, this is the most upto- date information we have on who to contact. Most often it comes from the clinicaltrials.gov website. In some cases we have called the manufacturer or the firm managing the trial to establish the best contact.

The International Clinical Trials Table has the same information with the addition of the contact and location information for international patients.

The Clinical Trials table is sorted first by “Phase” with higher phases first and then by “Therapy” within each phase.

We are publishing versions of these tables on our website with hot links to the trial descriptions. Go to “Treatments” on www.liferaftgroup.org and follow the “Clinical Trials” menu item to “Clinical Trial Datasheets.”

We are interested in your feedback on the new table design. Please send comments to Sara Rothschild at: srothschild@liferaftgroup.org.

Below are the updates that have been changed in the clinical trial update since the February 2007 newsletter:

A second site for the IPI-504 phase I trial has opened at University of Michigan, Ann Arbor, Mich. The contact is Rashmi Chugh, M.D., 734-936-0453, rashmim@umich.edu.

The Perifosine + Sunitinib phase I trial listing now shows sites recruiting in Pomona and Santa Monica, Calif., as well as Kalamazoo, Mich. and Huntsville, Ala. The Park Ridge, Ill. site is no longer listed.

The RAD001 trial is closed and is no longer listed in our report as we wait for Novartis on future plans. We continue to get reports of patients prescribed “Rapamune” off-label.

The BMS-354825 phase I trial is now listed as “no longer recruiting” at all sites in the United States and the United Kingdom. A separate phase I trial for BMS-354825 continues to remain open in Japan and is reflected for the first time in our report.

The BAY 43-9006 phase II trial is now also open at City of Hope in Duarte, Calif. in addition to the University of Chicago and Memorial Sloan-Kettering Cancer Center.

The OSI-930 phase I trial contact at the University of Colorado Cancer Center trial site in Aurora, Colo. is Dr. Ross Camidge.

 

To view the latest clinical trials, visit: http://www.liferaftgroup.org/docs/gist_clinical_trial_datasheets.htm.htm