TRIAL DETAIL

Study to Assess the Safety of Escalating Doses of AT13387 in Patients With Metastatic Solid Tumors

Drug:	AT13387
Trial Name:	Study to Assess the Safety of Escalating Doses of AT13387 in Patients With Metastatic Solid Tumors
NCT#:	NCT00878423
Conditions:	Solid Tumors
Status:	Completed
Phase:	1	Start Date 05/01/2008	Age of Trial (yrs) 16.6
Treatment Phase:	Gleevec-resistant
Drug Category:	HSP90 inhibitor
Strategy:	Destroy KIT
Trial Type:	GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:	AT13387/0001
Sponsor:	Astex Therapeutics, Ltd
Patient Contact:	Andrew Wolanski 617-632-6623 Andrew_Wolanski@dfci.harvard.edu
Contact email:
Contact Phone:
Randomized:
IV or Oral:	Intravenous
Trial Notes:	In pre-clinical models NSCLC and melanoma were found to be most sensitive to AT13387. Excludes patients who have had previous treatment with HSP-90 inhibitors. Drug: AT13387 The starting dose will be 10mg/m2/dose, given as one hour intravenous (IV) infusions on Days 1, 4, 8, 11, 15 and 18 of a twenty-eight day cycle. Drug: AT13387 Intravenous infusion over one hour on days 1, 4, 8, 11, 15 and 18 every four weeks. Treatment may be continued indefinitively in the presence of clinical benefit Increasing doses of AT13387 will be administered to groups of 3 to 6 patients at each dose level. The pharmacokinetic profile of AT13387 following a one hour intravenous infusion will be determined and the effect of AT13387 on predefined biomarkers in blood plasma and circulating white blood cells will be established. Patients will be closely monitored for the development of side effects which would preclude further dose escalation.

Trial Links

Astex pipeline with AT13387 Status

Drugs.com article on EOTRC-NCI-AACR Conference October 2008 presentation by Astex

Trial Results

First-in-Human Phase I Dose Escalation Study of a Second-Generation Non-Ansamycin HSP90 Inhibitor, AT13387, in Patients with Advanced Solid Tumors

Drug Information

LRG Article - Resistant GIST may fall to new inhibitor Note: Although this mentions a different HSP90 inhibitor, it remains possible that other potent HSP90 inhibitors may have benefit in GIST.

Astex Therapeutics drug pipeline page.

Astex Therapeutics Presentations page

AT13387, a fragment-derived clinical candidate is active in lung cancer and melanoma models (poster PDF)

The HSP90 inhibitor, AT13387, is effective against imatinib-sensitive and -resistant gastrointestinal stromal tumor models.

Trial Sites

Name	Address	City	State	Zip	Country
Beth Israel Deaconess Medical Center	330 Brookline Ave.	Boston	MA	02215	USA
Massachusetts General Hospital	55 Fruit Street	Boston	MA	02114	USA
Dana Farber Cancer Institute	450 Brookline Ave	Boston	MA	02215-5450	USA
Arizona Cancer Center	1515 North Campbell Avenue	Tucson	AZ	85724-5024	USA