April 2008 US clinical trials update

By Jim Hughes
LRG Science Team Member

Clinical trial contact information for Dana Farber Cancer Institute (DFCI) in Boston has changed. Michael (Travis) Quigley, RN has been replaced by Melissa Hohos, RN. Melissa can be reached at 617-632-2201 or mhohos@ partners.org. Melissa is the main contact for all GIST related trials at DFCI.

AMN107 Phase III:

The St. Vincent’s site in New York, N.Y., is now open. We have heard unofficially that U.S. accrual for this trial is nearly complete and is expected to end March 31, 2008.

Sunitinib or Imatinib Phase III:

The Fox Chase Cancer Center (FCCC) site in Philadelphia, Penn. is pending and expected to open shortly. Check with Monica Davey, RN, 215-728-5534.

BIIB021 Phase I & II: New trials.

Phase I- This drug from Biogen Idec is a HSP90 inhibitor (Was called CNF2024 in Phase I and administered twice weekly) and will be administered once or twice daily.
Phase II- New York site is open. The Mayo Clinic site in Rochester, Minn. is pending.

Sorafenib Phase II:

Sites have been updated. Ohio State University and DFCI have been removed. Added sites can be found in the table on page 8.

XL820 Phase II:

A DFCI site has been added. Unofficially, we have been told that eight more sites are pending. Christiaan McEwen at Quintiles is the project manager 415-337-1754, christiaan.mcewen@quintiles.com.

Imatinib & Sunitinib Phase I:

This new trial, sponsored by Vanderbilt and the National Cancer Institute. Both are approved GIST treatment, but toxicity and dose optimization studies must be conducted.

IPI-504 Phase I:

Trial has met accrual and is no longer accepting patients. Maximum Tolerable Dose (MTD) was also reached. A Phase II trial is planned.

BGT226 Phase I:

This new drug from Novartis is a PI3K inhibitor. It acts by inhibiting KIT downstream signaling. PI3K is a key protein in multiple cell functions and in cancer cell signaling including GIST signaling. Researchers hope to inhibit growth and stimulate cell death by inhibiting PI3K.

GDC-0941 Phase I:

This new drug from Genentech is a PI3K inhibitor. KOS1022 Phase I: According to Kosan’s (the manufacturer) press release, drug development will stop with focus shifting to another HSP90 inhibitor.

Perifosine & Sorafenib Phase I:

This trial is in the second of a two part Phase I and no longer accrues GIST patients.

SF1126 Phase I:

This Phase I trial sponsored by manufacturer, Semafore, tests the safety of SF1126, a pro-drug that produces LY294002 (a pan PI3K inhibitor) in the body. However, Semafore designed SF1126 to concentrate in tumors and thereby avoid toxic sideeffects associated with these inhibitors.

STA-9090 Phase I:

This is now open at Premiere Oncology in Santa Monica, Calif.

XL147 Phase I:

XL147 is a PI3K inhibitor from Exelixis. XL147 targets PI3K primarily and is given orally. XL765, another Exelixis PI3K inhibitor in Phase I (reported in January LRG issue) inhibits both PI3K and mTOR.

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