TRIAL DETAIL

Study of IPI-504 in GIST patients following failure of at least imatinib and sunitinib

Drug:
Trial Name:
Study of IPI-504 in GIST patients following failure of at least imatinib and sunitinib
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Terminated
Phase:
3
Start Date 08/15/2008
Age of Trial (yrs) 12.8
Treatment Phase:
Gleevec-resistant
Drug Category:
HSP90 inhibitor
Strategy:
Destroy KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
IPI-504-06
Sponsor:
Infinity MedImmune AstraZeneca
Patient Contact:
GIST Phase 3 Team http://www.ringtrial.com/
Contact email:
RINGtrialinfo@infi.com
Contact Phone:
877-504-4634
Randomized:
Randomized
IV or Oral:
IV Intravenous
Trial Notes:
CAMBRIDGE, Mass., April 15, 2009 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced that, based on the recommendation of its independent data monitoring committee (IDMC), Infinity has elected to terminate the RING trial, a double-blind, placebo-controlled international Phase 3 registration trial of IPI-504 (retaspimycin hydrochloride) in patients with refractory gastrointestinal stromal tumors (GIST).

The IDMC's recommendation yesterday evening to halt the trial was based on an early review of safety data from the first 46 patients enrolled in the study, which showed a higher than anticipated mortality rate among patients enrolled in the treatment arm.

IPI-504-06 was a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of IPI-504, an Hsp90 inhibitor made by Infinity, as compared to placebo in patients with metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib.

Trial design called for patients to be randomized using a 2:1 ratio to receive either IPI-504 or placebo.

Trial Links

 
 

Trial Results

 
 
 

Drug Information

Infinity halts the phase III RING trial in GIST
 
LRG story - IPI-504 completes phase I
 
LRG story - Infinity launches trial of IPI-504 for GIST
 
LRG story - Resistant GIST may fall to new inhibitor
 
LRG story - IPI-504 enters phase III
 
Infinity website - pipeline, IPI-504
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
1700 Luther Ln
Park Ridge
IL
60068
USA
New Bern
NC
28562
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
1500 E. Duarte Road
Duarte
CA
91010
USA
8700 Beverly Blvd.
Los Angeles
CA
90048
USA
10945 Le Conte Ave.
Los Angeles
CA
90095
USA
2450 Riverside Ave.
Minneapolis
MN
55454
USA
2003 Lincoln Way
Coeur d'Alene
ID
83814
USA
535 Barnhill Drive
Indianapolis
IN
46202
USA
100 Blossom St
Charlestown
MA
02114
USA
Flinders Drive
Bedford Park
South Australia
5042
Australia
520 South Road
Kurrulta Park
South Australia
5037
Australia
1665 N. Ursula St.
Aurora
CO
80045
USA
110 Irving St
Washington
DC
20010
USA
5841 S. Maryland Ave
Chicago
IL
60637
USA
Miami Beach
FL
33140
USA
New York
NY
10011
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
Auchenflower
Queensland
Australia
Brussels
Belgium
Seoul
Songpa-gu
138-736
Republic of Korea
Barker Street
Randwick
New South Wales
2031
Australia
10 St Andrews Place
East Melbourne
Victoria
3002
Australia
Wilrijk
Brussels
1200
Belgium
Villejuif
Val de Narne
94805
France
Saint-Herblain
Loire Atlantique
44805
France
Pieskower Stra├če 33
Bad Saarow
15526
Germany
Hufelandstr. 55
Essen
45122
Germany
Hannover
30625
Germany
Mannheim
68167
Germany
Seoul
Republic of Korea
Lund
SE-221 85
Sweden
Umea
90185
Sweden