GIST Clinical Trial Results
Front-line Trials-Patients received no prior molecularly targeted therapy
Phase I Trials
Effect of the Tyrosine Kinase
Inhibitor STI571 in a Patient
with a Metastatic
Gastrointestinal Stromal Tumor
NEJM, Full-text (requires
registration) This is the report of
the first GIST patient to ever
take Gleevec
Heikki
Joensuu, M.D., Peter J. Roberts,
M.D., Maarit Sarlomo-Rikala,
M.D., Leif C. Andersson, M.D.,
Pekka Tervahartiala, M.D., David
Tuveson, M.D., Sandra L.
Silberman, M.D., Ph.D., Brian
Druker,M.D., and George D.
Demetri, M.D.
Safety and efficacy of imatinib
(STI571) in metastatic
gastrointestinal stromal
tumours: a phase I study.
Pubmed abstract
van
Oosterom AT, Judson I, Verweij
J, Stroobants S, Donato di Paola
E, Dimitrijevic S, Martens M,
Webb A, Sciot R, Van Glabbeke M,
Silberman S, Nielsen OS;
European Organisation for
Research and Treatment of Cancer
Soft Tissue and Bone Sarcoma
Group.
STI 571, an Active Drug in
Metastatic Gastro Intestinal
Stromal Tumors (GIST), an EORTC
Phase I Study.
Abstract No:
2 2001 ASCO
Author(s): Allan T. Van Oosterom,
I. Judson, J. Verweij, E. Di
Paola, M. van Glabbeke, S.
Dimitrijevic, O. Nielsen, UZ
Gasthuisberg KULeuven, Leuven,
Belgium; EORTC Soft Tissue and
Bone Sarcoma Group, Brussels,
Belgium.
Update of the Imatinib (STI571,
Glivec) phase I study in gastro
intestinal stromal tumours
(GISTs).
Abstract No: 327 2002 ASCO
Allan T van Oosterom, Ian
Judson, Jaap Verweij, Eugenio
Donato di Paola, Sasa
Dimitrijevic, Herlinde Dumez,
Michelle Scurr, Raf Sciot,
Sandra Silberman, Martine Van
Glabbeke, Ole S Nielsen, UZ
Kuleuven, Leuven, Belgium; Royal
Marsden Hospital, London, UK; AZ
Rotterdam - Daniel Den Hoed
Kliniek, Rotterdam, Netherlands;
European Organisation for
Research and Treatment of
Cancer, Brussels, Belgium;
Novartis Pharma AG, Basel,
Switzerland; Novartis
Pharmaceuticals, E. Hanover, NJ;
Aarhus Kommunehospital, Aarhus,
Denmark.
Phase II Trials
Outcome of Advanced
Gastrointestinal Stromal Tumor
(GIST) Patients Treated With
Imatinib Mesylate:Four-Year
Follow-Up of a Phase II
Randomized Trial
Poster PDF 71KB
ASCO 2006 Abstract*
ASCO 2006 Presentation
C.
D. Blanke, H. Joensuu, G. D.
Demetri, M. C. Heinrich, B.
Eisenberg, J. Fletcher, C. L.
Corless, E. Wehrle, K. B.
Sandau, M. von Mehren
NOTE:
*The submitted abstract
mistakenly stated that 63% of
patients have died of
Progressive Disease. The correct
value is 40%.
Evaluation of the Safety and
Efficacy of an Oral
Molecularly-Targeted Therapy,
STI571, in Patients (Pts) with
Unresectable or Metastatic
Gastrointestinal Stromal Tumors
(GISTS) Expressing C-KIT
(CD117).
Abstract No: 1
2001 ASCO
Author(s): Charles D. Blanke,
Margaret von Mehren, Heikki
Joensuu, Peter J. Roberts,
Burton Eisenberg, Michael
Heinrich, Brian Druker, David
Tuveson, Sasa Dimitrijevic,
Sandra L. Silberman, George D.
Demetri, Oregon Health Sciences
University, Portland, OR; Fox
Chase Cancer Center,
Philadelphia, PA; Helsinki
University Central Hospital,
Helsinki, Finland; University of
Turku, Turku, Finland;
Dana-Farber Cancer Institute,
Boston, MA; Novartis Oncology,
Basel, Switzerland; Novartis
Oncology, East Hanover, NJ.
Efficacy and Safety of Imatinib
Mesylate in Advanced
Gastrointestinal Stromal Tumors
NEJM, Full-text article
(requires registration)
George D. Demetri, M.D.,
Margaret von Mehren, M.D.,
Charles D. Blanke, M.D., Annick
D. Van den Abbeele, M.D., Burton
Eisenberg, M.D., Peter J.
Roberts, M.D., Michael C.
Heinrich, M.D., David A. Tuveson,
M.D., Ph.D., Samuel Singer,
M.D., Milos Janicek, M.D.,
Ph.D., Jonathan A. Fletcher,
M.D., Stuart G. Silverman, M.D.,
Sandra L. Silberman, M.D.,
Ph.D., Renaud Capdeville, M.D.,
Beate Kiese, M.Sc., Bin Peng,
M.D., Ph.D., Sasa Dimitrijevic,
Ph.D., Brian J. Druker, M.D.,
Christopher Corless, M.D.,
Christopher D.M. Fletcher, M.D.,
and Heikki Joensuu, M.D.
High incidence of durable
responses induced by imatinib
mesylate (Gleevec) in patients
with unresectable and metastatic
gastrointestinal stromal tumors
(GISTs)
Abstract No: 1608
2002 ASCO
Author(s): Margaret von Mehren,
Charles Blanke, Heikki Joensuu,
Mike C Heinrich, Peter Roberts,
Burton Eisenberg, Sandra
Silberman, Sasa Dimitrijevic,
Beate Kiese, Jonathan Fletcher,
Christopher Fletcher, George D
Demetri, Fox Chase Cancer Ctr,
Philadelphia, PA; OHSU,
Portland, OR; University
Hospital, Helsinki, Finland;
Novartis Oncology, E. Hanover,
NJ; Novartis Oncology, Basel,
Switzerland; Dana-Farber Cancer
Inst, Boston, MA.
Phase II clinical study of
STI571 in Japanese (Jpn)
patients (pts) with malignant
gastrointestinal stromal tumors
(GIST): Results of the B 1201
study.
Abstract No: 4078 2004 ASCO
Citation: Journal of Clinical
Oncology, 2004 ASCO Annual
Meeting Proceedings
(Post-Meeting Edition). Vol 22,
No 14S (July 15 Supplement),
2004: 4078
Author(s):
T. Doi, T. Nishida, S. Hirota,
T. Sugiyama, K. Yamao, M. Koseki,
T. Okamura, K. Shirao, A. Ohtsu;
National Cancer Center Hospital
East, Kashiwa, Japan; Osaka
University Graduate School of
Medicine, Suita, Japan; Hokkaido
University Medical Hospital,
Sapporo, Japan; Aichi Cancer
Center, Nagoya, Japan; National
Kure Medical Center, Kure,
Japan; National Kyusyu Cancer
Center, Fukuoka, Japan; National
Cancer Center Hospotal, Tokyo,
Japan
Efficacy of imatinib mesylate in
metastatic or unresectable
malignant gastrointestinal
stromal tumor (GIST)
Abstract No: 3312
M.-H. Ryu, T.-W. Kim, H.-M.
Chang, H. Lee, J.-S. Kim, W.-K.
Kim, J.-S. Lee, Y.-K. Kang; Asan
Medical Center, University of
Ulsan College of Medicine,
Seoul, South Korea
A two arm phase 2 study of
temozolomide (T) in
gastrointestinal stromal tumors
(GISTs) and other soft-tissue
sarcomas (STS).
2003 ASCO Abstract
2003 ASCO Presentation
Abstract No. 3298
J.
C. Trent, J. Beach, M. A.
Burgess, L. L. Chen, R. S.
Benjamin, S. R. Patel; MD
Anderson Cancer Ctr, Houston, TX
Phase III Trials
Progression-free survival in
gastrointestinal stromal tumours
with high-dose imatinib:
randomised trial The
Lancet, abstract (requires
registration) This is the European
Phase III trial (EORTC)
Jaap
Verweij, Paolo G Casali, John
Zalcberg, Axel LeCesne, Peter
Reichardt, Jean-Yves Blay, Rolf
Issels,
Allan van Oosterom, Pancras
CWHogendoorn, Martine Van
Glabbeke, Rossella Bertulli, Ian
Judson, for the EORTC Soft
Tissue and Bone Sarcoma Group,
the Italian Sarcoma Group, and
the Australasian
Gastrointestinal Trials GrouNational
Comprehensive Cancer Network (NCCN)
clinical practice Guidelines for
Sarcoma (including GIST)
Outcome of patients with
advanced gastro-intestinal
stromal tumours crossing over to
a daily imatinib dose of 800mg
after progression on 400mg.
Pubmed abstract
2004 ASCO Abstract (No. 9004)
2004 ASCO Presentation
Zalcberg JR, Verweij J, Casali
PG, Le Cesne A, Reichardt P,
Blay JY, Schlemmer M, Van
Glabbeke M, Brown M, Judson IR;
for the EORTC Soft Tissue and
Bone Sarcoma Group, the Italian
Sarcoma Group and the
Australasian Gastrointestinal
Trials Group.
Dose effect of imatinib (IM) in
patients (pts) with metastatic
GIST - Phase III Sarcoma Group
Study S0033.
2004 ASCO Abstract
2004 ASCO Presentation
Abstract No. 9005
C. Rankin, M. Von Mehren, C.
Blanke, R. Benjamin, C. D. M.
Fletcher, V. Bramwell, J.
Crowley, E. Borden, G. D.
Demetri, Collaborating
Investigators of the North
American Sarcoma Intergroup; The
Sarcoma Group and SWOG
Statistical Center, Seattle, WA;
Fox Chase Cancer Ctr, ECOG, and
The Sarcoma Group, Philadelphia,
PA; OHSU, SWOG, and The Sarcoma
Group, Portland, OR; MD Anderson
Cancer Ctr and The Sarcoma
Group, Houston, TX; Brigham and
Women's Hospital and The Sarcoma
Group, Boston, MA; NCI Canada
and The Sarcoma Group, Calgary,
SK, Canada; Cleveland Clinic,
SWOG, and The Sarcoma Group,
Cleveland, OH; Dana-Farber
Cancer Institute, CALGB, Sarcoma
Group, Boston, MA
Continuous vs intermittent
imatinib treatment in advanced
GIST after one year: A
prospective randomized phase III
trial of the French Sarcoma
Group.
2004 ASCO Abstract
2004 ASCO Presentation
Abstract No. 9006
2005 ASCO Abstract 9031 (update)
J.-Y. Blay, P. Berthaud, D.
Perol, I. Ray-Coquard, B. Bui,
F. Duffaud, A.-C. Braud, M.
Rios, F. Ducimetiere, A. Le
Cesne; Hop. E. Herriot & C. L.
Berard, Lyon Cedex 08, France;
Novartis Pharma, Rueil Malmaison,
France; Centre Leon Berard, Lyon
Cedex 08, France; Institut
Bergonie, Bordeaux, France;
Hopital de La Timone, Marseille,
France; Institut Paoli Calmettes,
Marseilles, France; Centre
Alexis Vautrin, Nancy, France;
Institut Gustave Roussy,
Villejuif, France
Phase III dose-randomized study
of imatinib mesylate (Gleevec,
STI571) for GIST: intergroup
S0033 early results
Abstract No. 1651 2002 ASCO
George D Demetri, Catherine
Rankin, Christopher Fletcher,
Robert S Benjamin, Charles
Blanke, Margaret Von Mehren,
Vivien Bramwell, Robert G Maki,
Ronald Blum, Karen Antman,
Laurence Baker, Ernest Borden,
Dana Farber Cancer Institute,
CALGB, and Sarcoma Intergroup,
Boston, MA; SWOG, San Antonio,
TX; Dana Farber Cancer Inst and
Intergroup, Boston, MA; M.D.
Anderson Cancer Center and
Intergroup, Houston, TX; ECOG,
Philadelphia, PA; NCI Canada,
London, ON, Canada; CALGB, New
York, NY.
Phase III dose-randomized study
of imatinib mesylate (STI571)
for GIST: Intergroup S0033 early
results.
2003 ASCO Abstract
2003 ASCO Presentation
Abstract No. 3271
R.
S. Benjamin, C. Rankin, C.
Fletcher, C. Blanke, M. Von
Mehren, R. Maki, V. Bramwell, L.
Baker, E. Borden, G. D. Demetri,
for the Sarcoma Intergroup; UT
MD Anderson Cancer Ctr, Houston,
TX; SWOG, San Antonio, TX;
Dana-Farber Cancer Institute,
Boston, MA; ECOG, Philadelphia,
PA; CALGB, New York, NY; NCIC,
Calgary, Canada; SWOG, Ann
Arbor, MI; DFCI, CALGB, and
Sarcoma Intergroup, San Antonio,
TX
Early efficacy comparison of two
doses of imatinib for the
treatment of advanced
gastro-intestinal stromal tumors
(GIST): Interim results of a
randomized phase III trial from
the EORTC-STBSG, ISG and AGITG.
2003
ASCO Abstract
2003 ASCO Presentation
Abstract No. 3272 NOTE:
The Presentation presents
updated information compared to
the abstract; specifically in
the presentation a statistically
significant difference in
progression-free survival was
noted; this was not noted in the
abstract.
J. Verweij, P. G. Casali, J.
Zalcberg, A. Le Cesne, P.
Reichard, J.-Y. Blay, R. D.
Issels, M. Van Glabbeke, E.
Donato Di Paola, I. R. Judson;
Erasmus Univ Mdcl Ctr,
Rotterdam, Netherlands; Istituto
per lo Studio e la Cura die
Tumori, Milano, Italy; Peter
Maccallum Cancer Institute,
Melbourne, Australia; Institut
Gustave Roussy, Villejuif,
France; Robert Roessle Klinik,
Berlin, Germany; Centre Leon
Berard, Lyon, France; Klinikum
Grosshadern, Munchen, Germany;
EORTC Data Center, Brussels,
Belgium; Royal Marsden Hospital,
London, UK
Imatinib (Glivec) 400 vs 800 mg
daily in patients with
gastrointestinal stromal tumors
(GIST): a randomized phase III
trial from the EORTC Soft Tissue
and Bone Sarcoma Group, the
Italian Sarcoma Group (ISG), and
the Australasian
Gastro-Intestinal Trials Group
(AGITG). A toxicity report.
Abstract No. 1650 2002 ASCO
Paolo G Casali, Jaap Verweij,
John Zalcberg, Axel LeCesne,
Peter Reichardt, Isabelle Ray-Coquard,
Clemens Wendtner, Ian Judson,
Eugenio D Di Paola, Martine Van
Glabbeke, Rossella Bertulli,
Haryana Dhillon, Ole S Nielsen,
Istituto Nazionale Tumori,
Milano, Italy; Daniel Den Hoed
Kliniek, Rotterdam, Netherlands;
Peter MacCallum Cancer
Institute, East Melbourne,
Australia; Institut
Gustave-Roussy, Villejuif,
France; Universitatsklinikum
Charite, Berlin, Germany; Centre
Léon Bérard, Lyon, France;
Klinikum Grosshadern, Munich,
Germany; Royal Marsden Hospital,
London, UK; EORTC Data Center,
Brussels, Belgium; AGITG
Coordinating Centre, Camperdown,
Australia; Aarhus
Kommunehospital, Aarhus,
Denmark.
Prognostic factors of toxicity
and efficacy in patients with
gastro-intestinal stromal tumors
(GIST) treated with imatinib: A
study of the EORTC-STBSG, ISG
and AGITG.
2003 ASCO Abstract
2003 ASCO Presentation
Abstract No. 3286
M. M. Van Glabbeke, J. Verweij,
P. G. Casali, J. Zalcberg, A. Le
Cesne, P. Reichard, J.-Y. Blay,
M. Schlemmer, E. Donato Di
Paola, I. R. Judson; EORTC Data
Center, Brussels, Belgium;
Erasmus Univ Mdcl Ctr,
Rotterdam, Netherlands; Istituto
Nazionale per lo Studio e la
Cura dei Tumori, Milano, Italy;
Peter Maccalum Cancer Institute,
Melbourne, Australia; Institut
Gustave Roussy, Villejuif,
France; Robert Roessle Klinik,
Berlin, Germany; Centre Leon
Berard, Lyon, France; Klinikum
Grosshadern, Munchen, Germany;
Royal Marsden Hospital, London,
UK
Gleevec-resistant GIST Trials (some trials may include other tumor types)
Phase I and Phase I/II Trials
Phase I
dose-escalation study of the SRC
and multi-kinase inhibitor BMS-354825 in patients (pts)
with GIST and other solid
tumors.
ASCO 2005 abstract
ASCO 2005 presentation
Abstract
No: 3034
Author(s): T. R. Evans, J. A.
Morgan, A. D. van den Abbeele,
I. R. McPherson, S. George, D.
Crawford, J. M. Mastrullo, S.
Cheng, J. A. Fletcher, G. D.
Demetri
Safety and
pharmacokinetics of AMG 706 in
patients with advanced solid
tumors
Abstract No: 3013
ASCO 2005 abstract
ASCO 2005 presentation
Author(s): L. Rosen, R. Kurzrock,
E. Jackson, L. Wathen, M.
Parson, M. Eschenberg, M. Mulay,
M. Purdom, L. Yan, R. S. Herbst
A phase I/II
trial of the oral mTOR-inhibitor
everolimus (RAD001) and
imatinib mesylate (Gleevec)
in patients (pts) with
gastrointestinal stromal tumor
(GIST) refractory to IM:
ASCO 2004 abstract
ASCO 2004 presentation
ASCO 2005 abstract
ASCO 2005 presentation Study
update
Abstract No. 3002
A. T. Van Oosterom, H. Dumez, J.
Desai, S. Stroobants, A. D. Van
Den Abbeele, P. Clement, N.
Shand, J. Kovarik, A. Tsyrlova,
G. D. Demetri; UZ Gasthuisberg,
Leuven, Belgium; Dana Farber
Cancer Institute, Boston, MA;
Novartis Pharma, Basel,
Switzerland
Clinical
activity and tolerability of the
multi-targeted tyrosine kinase
inhibitor SU11248 in
patients (pts) with metastatic
gastrointestinal stromal tumor
(GIST) refractory to imatinib
mesylate.
Abstract No: 3273 ASCO
2003 Abstract
ASCO 2005 abstract
ASCO 2005 presentation
Citation: Proc Am Soc Clin Oncol
22: page 814, 2003 (abstr 3273)
Author(s): G. D. Demetri, S.
George, M. C. Heinrich, J. A.
Fletcher, C. D. M. Fletcher, J.
Desai, D. P. Cohen, P. Scigalla,
J. M. Cherrington, A. D. Van Den
Abbeele, for the GIST SU11248
Study Group; Dana-Farber Cancer
Institute, Boston, MA; OHSU,
Portland, OR; Brigham and
Women's Hospital and DFCI,
Boston, MA; Pharmacia Corp.,
Peapack, NJ; Sugen Inc., S. San
Francisco, CA
A phase I/II trial of the oral
PKC-inhibitor PKC412 (PKC) in
combination with imatinib
mesylate (Gleevec) in
patients (pts) with
gastrointestinal stromal tumor
(GIST) refractory to IM.
ASCO 2005 abstract
ASCO 2005 presentation
Abstract No: 3016
Author(s): P. Reichardt, D.
Pink, T. Lindner, M. C.
Heinrich, P. S. Cohen, Y. Wang,
R. Yu, A. Tsyrlova, S.
Dimitrijevic, C. Blanke
Results with AMN107, a novel
kinase inhibitor, in
gastrointestinal stromal tumor
(GIST): Preclinical rationale
and early results in a patient
(Pt) with imatinib
(IM)-resistant GIST
ASCO 2006 Gastrointestinal
Cancers Symposium
Abstract No. 53
Phase II Trials
Phase III Trials
Phase 3,
multicenter, randomized,
double-blind, placebo-controlled
trial of SU11248 in
patients (pts) following failure
of imatinib for metastatic GIST
ASCO 2005 abstract
ASCO 2005 presentation
Abstract No: 4000
Author(s): G. D. Demetri, A. T.
van Oosterom, M. Blackstein, C.
Garrett, M. Shah, M. Heinrich,
G. McArthur, I. Judson, C. M.
Baum, P. G. Casali
Continuation Trials
Results from a
continuation trial of SU11248
in patients (pts) with imatinib
(Gleevec)-resistant
gastrointestinal stromal tumor
(GIST)
Abstract No: 9011
ASCO 2005 abstract
ASCO 2005 presentation
Author(s):
R. G. Maki, J. A. Fletcher, M.
C. Heinrich, J. A. Morgan, S.
George, J. Desai, K. Scheu, C.
D. Fletcher, C. Baum, G. D.
Demetri
Adjuvant Treatment
Adjuvant
imatinib mesylate in patients
with primary high risk
gastrointestinal stromal tumor
(GIST) following complete
resection: Safety results from
the U.S. Intergroup Phase II
trial ACOSOG Z9000 ASCO 2005 abstract
ASCO 2005 presentation
Abstract No: 9009
Author(s):
R. P. Dematteo, C. R. Antonescu,
V. Chadaram, Y. N. You, L.
McCall, R. Maki, A. Murgo, G.
Demetri, P. Pisters, M. F.
Brennan, American College of
Surgeons Oncology Group (ACOSOG)
