july 2009 ct - gist support group & information center … jim hughes lrg clinical trials...

By Jim Hughes LRG Clinical Trials Coordinator In this month’s Clinical Trials Bulletin

we highlight a new class of drugs that target Insulin-like Growth Factor 1 Re-ceptor (IGF-1R). IGF-1R is a tyrosine kinase that, much like KIT, protrudes through the cell surface and begins to signal when an extracellular Insulin Growth Factor (IGF1) attaches to the outside portion of the receptor. Unlike KIT, IGF-1R has not been found to be mutated in GIST. However, IGF-1R has been found to be over-expressed in wild-type GIST tumor tissue. Up to now, KIT inhibitors have had limited impact in wild type GIST. IGF-1R is now viewed as a component of a potential “side chan-nel” providing an alternative signaling path to KIT and potentially a target in GIST.

In experiments with wildtype GIST cells, researchers at Fox Chase Cancer

Center have demonstrated the ability to slow cell growth with both IGF-1R in-hibitors and combinations of IGF-1R and KIT inhibitors. These promising results are leading to new trial designs specifi-cally for GIST patients.

IGF-1R inhibitors are a very active area of drug development. We have identified over a dozen compounds both in the lab and in early clinical trials. Many are in trials that are open to solid tumors or advanced malignancies and should accept GIST patients.

As with all Phase I trials, the trial ob-jective is to determine a safe dosage and to document safety issues. Efficacy is not determined until phase II or III. Pa-tients entering phase I are not guaranteed a therapeutic dosage nor is there an easy way of measuring all the risks. However, for those experiencing resistance or un-controllable growth, Phase I trials pro-vide an option until the new GIST-specific trials, such as the planned NIH

trial, are on-line. IGF-1R inhibitors are of two types:

small molecule and monoclonal-antibodies.

Small molecule inhibitors work in much the same way as Imatinib or Sunit-inib work against KIT. They block the IGF-1R molecule usually at a signaling point inside the cell.

Monoclonal antibodies work by bind-ing to the IGF-1R protein portion outside the cell and thereby prevent the IGF1 ligand from binding to the receptor and initiating the tyrosine kinase signaling process.

Both methods can effectively stop IGF-1R signaling. Monoclonal antibodies tend to be more specific to their targets.

July 2009 Clinical Trials Update

The Life Raft Group

Who are we, what do we do?

The Life Raft Group (LRG) directs re-search to find a cure for a rare cancer and help those affected through support and advocacy until we do. The LRG provides support, information and assistance to patients and families with Gastrointestinal Stromal Tumor (GIST). The LRG achieves this by providing an online community for patients and caregiv-ers, supporting local in-person meetings, patient education through monthly newslet-ters and webcasts, one-on-one patient consultations, and most importantly, man-aging a major research project to find the cure for GIST.

Disclaimer

We are patients and caregivers, not doc-tors. Information shared is not a substitute for discussion with your doctor. For the very latest information, see the LRG Clinical Trials database at: http://liferaftgroup.org/treat_trials.html.

See Page 2

Insulin-like Growth Factor Receptor signaling

Small molecules can have collateral tar-gets that can either enhance tumor inhi-bition and/or caused unwanted side-effects. Most IGF-1R inhibitors in trials today are monoclonal antibodies. The exceptions are OSI-906 and XL228.

When drugs are assigned a generic

name you can usually tell which are monoclonal antibodies because they all have the suffix ‘mab’. Figitumumab (CP-751,871) and Cixutumumab (IMC-A12) are two examples.

One caution when evaluating IGF-1R trials is to be aware that some trials pre-clude the use of any prior IGF-1R ther-apy (BIIB022 and AMG 479). You may

want to take this into account in optimiz-ing your trial plan.

In this months report we have included eleven new Phase 1 trials of IGF-1R in-hibitors. Two of these will accept pa-tients younger than eighteen. This months report also reflects the termina-tion of the imatinib plus RAD001 trial that was accruing at nine sites in Ger-many.

FROM PAGE 1

Don’t forget to check out the

LRG Newsletter at www.

gistnews.org!

2

Note: Trials are first grouped together by treatment phase. For example, the first grouping lists 2 trials thatare open to patients in all treatment stages. Each trial description also lists the treatment stage under the "Stage" heading. Trials that are specifically for GIST are listed first. Trials are then sorted by phase in descending order) and then by drug name. Trial sites are sorted by country, state and then city.

AllTreatment Stage:

ImatinibImatinib Mesylate in Treating

Patients With Liver Metastasis Froma Gastrointestinal Stromal Tumor

Phase: 2

See site contact info below

Conditions: Gastrointestinal Stromal Tumor

NCT #: NCT00764595Contact:

Strategy: Block KIT

Stage: All

Drug Type: KIT/PDGFRA inhibitor

Niigata University Medicaland Dental SchoolNiigata, Japan81-25-227-2228Tatsuo Kanda, MD

SurgerySurgery in Treating Patients With

Liver Metastasis From a Gastrointestinal Stromal Tumor

Phase: 2




Strategy: Surgery

Stage: All

Drug Type: Surgery

Niigata University Medicaland Dental SchoolNiigata, Japan81-25-227-2228Tatsuo Kanda, MD

First-lineTreatment Stage:

Imatinib + BevacizumabImatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

Phase: 3

See each trial site.



Strategy: Block KITBlock tumor blood vessel growth

Stage: First-line

Drug Type: KIT/PDGFRA inhibitor+ VEGF inhibitor (antibody)

USC/Norris Comprehensive Cancer CenterLos Angeles, CA USAClinical Trials Office323-865-0451

Iowa Oncology Research Association - CCOPDes Moines, IA USA515-244-7586Roscoe F. Morton, MDUniversity of ChicagoChicago, IL USAClinical Trials Office, 773-834-7424Hedy Kindler, MDWichita - CCOPWichita, KS USA316-262-4467Shaker R. Dakhil, MDMichigan Cancer ResearchConsortium =- CCOPAnn Arbor, MI USA734-434-4930Phillip J. Stella, MD

Kalamazoo - CCOPKalamazoo, MI USA269-373-7458Raymond S. Lord, MDMetro Minnesota - CCOPSt. Louis ParK, MN USA592-993-1517Patrick J. Flynn, MDOzarks Regional - CCOPSpringfield, MO USA417-269-4520John W. Goodwin, MDUniversity of Mississippi Cancer ClinicJackson, MS USARobert D. Hamilton601-984-5590

Montana Cancer Consortium - CCOPBillings, MT USA406-238-6290Benjamin Marchello, MDSoutheast Cancer ControlConsortium - CCOPWinston-Salem, NC USA910-777-3036James M. Atkins, MDRoswell Park Cancer InstituteBuffalo, NY USAClinical Trials Office877-275-7724

Syracuse Hematology-Oncology Associate of Central New York - CCOPEast Syracuse, NY USA315-472-7504Jeffrey J. Kirshner, MDColumbus - CCOPColumbus, OH USA614-443-2267Philip J. Kuebler, MDDayton Clinical OncologyProgram - CCOPKettering, OH USA937-395-8678Howard M Gross, MDToledo Community Hospital Oncology - CCOPToledo, OH USA419-255-5433Paul L. Schaefer, MD

3

Columbia River OncologyProgram - CCOPPortland, OR USA503-216-6260Janet C RuzichKnight Cancer Institute atOregon Health Sciences University (OHSU)Portland, OR USA503 494-6594Michael Heinrich, MDGeisinger Clinical & Medical Center - CCOPDanville, PA USA570-271-6413Albert M. Bernath, MDFox Chase Cancer CenterPhiladelphia, PA USA1-888-FOX-CHASEMargeret von Mehren, M.D.Gibbs Regional Cancer Center - CCOPSpartanburg, SC USA864-560-7050James Bearden, III, MDCancer Therapy and Research CenterSan Antonio, TX USAClinical Trials Office210-616-5798

University of Texas HealthScience CenterSan Antonio, TX USADorothy Nguyen210-567-4777

Fred Hutchinson Cancer Research CenterSeattle, WA USA206-386-2441Saul E. Rivkin, MDMarshfield Medical Research & Education Foundation - CCOPMarshfield, WI USA715-387-5426Mohammad Q. Khan, MD, FACP

Masitinib, (AB1010)Efficacy and Safety of Masitinib

(AB1010) in Comparison to Imatinibin Patients With Gastro-Intestinal

Stromal TumourPhase: 3

Centre Oscar LambretAntoine Adenis, [email protected]+33 (0)3 20 29 59 59



Strategy: Block KIT

Stage: First-line


Hopital Jean MinjozBesancon, France

Institut BergonieBordeaux, FranceBinh Bui Nguyen, MDCentre Georges Francois LeclercDijon, France

Centre Hospitalier Victor JousselinDreux, France

Centre Oscar Lambret - LilleLille, FranceAntoine Adenis, MDCentre Leon BerardLyon, [email protected] Yves-Blay, MD, PhDInstitut Paoli CalmetteMarseilles, FrancePatrice Viens, MD, PhDCentre Val d'AureleMontpellier, France

Centre Rene GauducheauNantes, France

Hopital de la SourceOrleans, France

Hopital Europeen GeorgesPompidouParis, France

Hopital Robert DebreReims, France

Hopital Charles NicolleRouen, France

Centre Rene HugueninSaint-Cloud, France

Hopital Saint-GeorgesBeirut, Lebanon

American University HospitalBeirut, Lebanon

Middle East Institute of HealthBsalim, Lebanon

Hopital Saint-JosephDora, Lebanon

Hamoud HospitalSaida, Lebanon

MD Anderson - OrlandoOrlando, FL USAClinical Trials Office - M.D.Anderson Cancer Center, 713-792-3245Jon Trent, MD, PhDHenry Ford Health SystemDetroit, MI USA

Beth Israel Medical CenterNew York, NY USA

4

Nilotinib or ImatinibPhase III, Open-Label Study of

Nilotinib Versus Imatinib in GIST Patients

Phase: 3

Novartis Pharmaceuticals



Strategy: Block KIT

+1-800-340-6843

Stage: First-line


Universitatsklinik f. InnereMedzin Onkologische AmbulanzInnsbruck, AustriaAnnaliese Gachter+43 512 504 [email protected] Wolfgang, MDUniversitatsklinik f. InnereMedzin IVienna, AustriaThomas Brodowicz, MD+43-40400-4466+43-40400-4685Thomas Brodowicz, MDHotel Dieu du QuebecQuebec, CanadaAnn Wright1-418-691-2950Felix Couture, MD1-418-691-5225Felix Couture, MDMount Sinai HospitalToronto, ON CanadaMartin Blackstein, MD011-416-586-5371Martin Blackstein, MDOttawa Regional Cancer Center University of OttawaOttawa, Ontario CanadaTim Asmis, MD613-737-7700 ext 70316Tim Asmis, MDMaisonneuve-Rosemont HospitalMontreal, QC CanadaJacinthe Lasalle, MD514-252-3400 ext 4670Lucas Sideris, MD

CHUM - Hopital Notre-DameMontreal, Quebec CanadaChantal Gosselin514-890-8000 ext. 24892Denis Soulieres, MDCHUS - Hospital FleurimontSherbrooke, Quebec CanadaBrigitte Jean1-819-346-1110 ext. 12872Rami Kotb, MDAichi Cancer Center HospitalAichi, JapanAkira Sawaki, [email protected] Sawaki, MDNational Cancer Center Hospital EastChiba, JapanToshihiko Doi, MD+81-4-7133-1111 [email protected] Doi, MDHokkaido University HospitalHokkaido, JapanYoshito Komatsu+81-11-706-5657Yoshito Komatsu, MDKanagawa Cancer CenterKanagawa, JapanHaruhiko Cho, MD+81-45-391-5791Haruhiko Cho, MDKumamoto University HospitalKumamoto, JapanHideo Baba, [email protected] Baba, MDNiigata University Medicaland Dental SchoolNiigata, JapanTatsuo Kanda, [email protected] Kanda, MDNational Hospital Organization - Osaka General HospitalOsaka, JapanToshimasa Tsujinaka, MD+81 6 6942 [email protected] Tsujinaka, MD

Osaka University HospitalOsaka, JapanToshirou Nishida, [email protected] Nishida, MDShizouka Cancer CenterShizuoka, JapanYusuke [email protected] Onozawa, MDNational Cancer Center HospitalTokyo, JapanYasuhide Yamada, MD+81 33 542 [email protected] Yamada, MDConsorci Hospitalari ParcTauliBarcelona, SpainJose G. [email protected] Pericay, MDUniversity Hospital La PazMadrid, SpainCristobal Belda-Iniesta, [email protected] Belda-Iniesta, MDChulalongkorn UniversityBangkok, ThailandVirote Sriuranpong, [email protected] Sriuranpong, MDSiriraj HospitalBangkok, ThailandVichien Srimuninnimit, MD+66-2-419-4488 [email protected]

Vichien Srimuninnimit, MDPrince of Songkla UniversitySongkla, ThailandPatrapim Sunpaweravong, [email protected] Sunpaweravong, MDCity of HopeDuarte, CA USANeeti Arora626-256-4673 xt [email protected] Chow, MD

5

City of Hope - PasadenaPasadena, CA USADoni Woo, RN626-396-2900Mark McNamara, MDMD Anderson Cancer CenterHouston, TX USADiane [email protected] Ta713-792-2848Jon Trent, MD, PhD

Dasatinib (BMS-354825)Dasatinib as First-Line Therapy in

Treating Patients With Gastrointestinal Stromal Tumors

Phase: 2




Strategy: Block KIT + Block KIT Signal Path

Stage: First-line

Drug Type: KIT/PDGFRA inhibitor + SRC inhibitor

Centre Hospitaleir Universitaire VaudoisLausanne, Switzerland41-21-314-0150Michael Montemurro, MD

NilotinibTreatment of Patients With Metastatic or Unresectable

Gastrointestinal Stromal Tumors inFirst Line With Nilotinib. (OPEN)

Phase: 2

Novartis Basel+ 41 61 324 1111



Strategy: Block KIT

Stage: First-line


Site name unknown, Bad SaarowBad Saarow, Germany

Site name unknown, MilanMilan, Italy

Gleevec-resistantTreatment Stage:

SunitinibSafety And Efficacy Study Of

Sunitinib Malate In Chinese PatientsWith Imatinib Resistant Or

Intolerant Malignant Phase: 4

Pfizer Oncology Clinical Trial Information [email protected] CT.gov Call Center1-800-718-1021



Strategy: Block KIT

Stage: Gleevec-resistant


Site name unknown Beijing100035Beijing, China

Site name unknown Beijing100071Beijing, China

Site name unknown, Beijing 100021Beijing, China

Site name unknown, Nanjing 210002Nanjing, Jiangsu China

6

Sunitinib or ImatinibSafety And Effectiveness Of Daily

Dosing With Sunitinib Or Imatinib InPatients With Gastrointestinal

Stromal Tumors (Resistant at 400 mgPhase: 3

Pfizer Oncology Clinical Trial Information Service1-877-369-9753PfizerCancerTrials@emergingmed.com1-800-718-1021



Strategy: Block KIT



Site name unknown Marseille, France 13385Marseille, France

Site name unknown, Goettingen 37075Goettingen, Germany

Site name unknown, Hamburg 22767Hamburg, Germany

Southwest German CancerCenter at Eberhard-KarlsUniversityTuebingen, [email protected] T. Hartmann, MDSite name inknown, HongKong, 0Hong Kong, Hong Kong

Site name unknown, Lai Chi Kok 0Lai Chi Kok, Kowloon HongKong SAR

Site name unknown, TuenMun 0Tuen Mun, New TerritoriesHong Kong SAR

Site name unknown, Bologna 40138Bologna, Italy

Istituto Nazionale Dei TumoriMilan, ItalyPaolo Casali MDSite name unknown, San Giovanni Rotondo 71013San Giovanni Rotondo, Foggia Italy

Site name unknown, Seoul135-710Seoul, Republic of Korea



Site name unknown, Barcelona 08036Barcelona, Spain

Site name unknown, Valencia 46009Valencia, Spain

Site name unknown, Glasgow G12 0YHGlasgow, UK

Royal Marsden HospitalLondon, UK

Site name unknown, London NW1 2PGLondon, UK

Site name unknown, London W1London, UK

Christie Hospital NHS TrustManchester, Lancashire UK

Karmanos Cancer InstituteDetroit, MI USAall (800) KARMANOS (1-800-527-6266) or e-mail [email protected] Sheilds, MDSite name unknown, Farmington Hills 48334Farmington Hills, MI USA

Site name unknown, Henderson 89074Henderson, NV USA

Site name unknown, Las Vegas 89102Las Vegas, NV USA



Cleveland Clinic Taussig Cancer CenterCleveland, OH USA

Fox Chase Cancer CenterPhiladelphia, PA USA1-888-FOX-CHASEMargeret von Mehren, M.D.

BIIB021 (CNF2024)An Open-Label, 18FDG-PET

Pharmacodynamic Assessment of theEffect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors

Phase: 2

Biogen [email protected]



Strategy: Destroy KIT


Drug Type: HSP90 inhibitor

Site name unknown, RochesterRochester, MN USA

Memorial Sloan-KetteringCancer CenterNew York, NY USARobert Maki, MD

7

NilotinibNilotinib in Advanced GISTPhase: 2




Strategy: Block KIT



Fox Chase Cancer CenterPhiladelphia, PA USA1-888-FOX-CHASE (369-2427)Margeret von Mehren, M.D.

NilotinibPhase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib

Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or

Phase: 2

Novartis Basel



Strategy: Block KIT

41 61 324 1111



Site name unknown, Tel AvivTel Aviv, Israel

Site name unknown, Tel HashomerTel Hashomer, Israel

Sorafenib (Nexavar, BAY43-9006)

Sorafenib in Treating Patients WithMalignant Gastrointestinal StromalTumor That Progressed During or

After Previous Treatment With Phase: 2

Clinical Trials Office - University of Chicago CancerResearch




773-834-7424


Drug Type: KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI) + RAFinhibitor

University of ChicagoChicago, IL USAClinical Trials Office, 773-834-7424Hedy Kindler, MD

Imatinib + SunitinibImatinib Mesylate and Sunitinib in

Treating Patients With Gastrointestinal Stromal Tumors

Phase: 1



Strategy: Block KIT



Vanderbilt-Ingram CancerCenter-Cool SpringsFranklin, TN USA615 343-4128Jordan BerlinVanderbilt-Ingram CancerCenter at FranklinFranklin, TN USA615 343-4128Jordan Berlin

Vanderbilt-Ingram CancerCenterNashville, TN USA800 811-8480Clinical Trials Office

Study to the Optimal Duration of Therapy With Oral Angiogenesis

InhibitorsPhase: 4




Strategy: Block tumor blood vessel growth


Drug Type: VEGFR inhibitor (TKI)

University Medical CenterNijmegen st RaboudNijmegen, Gelderland Netherlands31 24 [email protected]

C.M.L van Herpen, Md, Phd

Dasatinib (BMS-354825)Trial of Dasatinib in Advanced

SarcomasPhase: 2

Kathleen [email protected]





Drug Type: KIT/PDGFRA inhibitor + SRC inhibitor

Arkansas Children's HospitalLittle Rock, AR USABryce [email protected] StineCity of HopeDuarte, CA USANeeti Arora626-256-4673 ext. [email protected] Chow, MD

8

Cedars-Sinai Outpatient Cancer CenterLos Angeles, CA USAChi [email protected] Forscher, MDStanford Cancer CenterPalo Alto, CA USAMaria [email protected]

Kristen Ganjoo, MDSarcoma Oncology CenterSanta Monica, CA USAViky Chua(310) [email protected] Chawla, MDWashington Cancer InstituteWashington, DC USAChristina Sheeran,202 [email protected] A. Priebat, MDUniversity of Iowa Hospitals and ClinicsIowa City, IA USAMelanie Frees, [email protected] Milhem, MDKootenai Cancer CenterCoeur d'Alene, ID USASheryl [email protected] Samuels, MDOncology Specialists, ParkRidgePark Ridge, IL USAKathy [email protected] Kaiser, MDIndiana University SimonCancer CenterIndianapolis, IN USAKristen Potter, [email protected] Rushing, MDMassachusetts General HospitalBoston, MA USAAnthony [email protected] Choy, MD

Dana Farber Cancer InstituteBoston, MA USASarah [email protected] Butrynski, MDJohns Hopkins Sidney Kimmel Comp Cancer CenterBaltimore, MD USAAdult Oncology, 410-955-8804Pediatric Oncology, 410-955-8751David Loeb, MD, PhDUniversity of MichiganAnn Arbor, MI USAGino [email protected] Schuetze, MD, PhDNebraska Methodist HospitalOmaha, NB USAGladys [email protected] Leu, MDPennsylvania Oncology Hematology AssociatesPhiladelphia, PA USADeb Riordan, RN, [email protected] Staddon, MDFox Chase Cancer CenterPhiladelphia, PA USA1-888-FOX-CHASEMargeret von Mehren, M.D.University of Pittsburgh Cancer InstitutePittsburgh, PA USALynne [email protected] Tawbi, MD, MScMD Anderson Cancer CenterHouston, TX USAJoanne [email protected] Patel, MD

EverolimusTreatment of Patients With RAD001

Who Have Progressive SarcomaPhase: 2

Novartis Pharmaceuticals+1 800-340-6843

Conditions: Sarcoma


Strategy: Block KIT Signal Path


Drug Type: mTOR inhibitor

Site name unknown, BerlinBerlin, Germany

Site name unknown, DusseldorfDusseldorf, Germany

Site name unknown, Mannheim 68135Mannheim, Germany

Site name unknown, MunchenMunchen, Germany

Site name unknown, MilanMilan, Italy

9

Doxorubicin + Flavopiridol

Doxorubicin and Flavopiridol in Treating Patients With Metastatic orRecurrent Sarcoma That Cannot Be

Removed By SurgeryPhase: 1


Conditions: Gastrointestinal Stromal TumorSarcoma


Strategy: Freeze the cell division cycle


Drug Type: Transcription inhibitor + Chemotherapy

Memorial Sloan-KetteringCancer CenterNew York, NY [email protected] D'Adamo, MD, PhD,

Imatinib + IL-2Imatinib + IL-2

Phase: 1



NCT #:Contact:

Strategy: Block KIT + Stimulate the immune system


Drug Type: KIT inhibitor + Immune stimulate

Institut Gustave-RoussyVillejuif Cedex, FrancePatricia Pautier, MD33 (0) 1 42 11 42 [email protected] Zitvogel, MD

Multi-bacteria vaccine (MBV)

A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1

Antigen.Phase: 1




Strategy: Stimulate the immune system


Drug Type: Immune stimulate

Krankenhaus NordwestFrankfurt, GermanyAntje [email protected] 7601 4161Elke Jaeger, MD

SF1126 A Phase I Open Label, Safety,

Pharmacokinetic and Pharmacodynamic Dose EscalationStudy in SF1126, a PI Kinase (PI3K)

Phase: 1


Conditions: Solid Tumors




Drug Type: PI3K inhibitor

TGen Clinical Research ServicesScottsdale, AZ USACathy Costanza, RN, BS, [email protected] [email protected] Ramanathan, MD

Arizona Cancer CenterTucson, AZ USADiane Rensvold, [email protected] Safarewitz, [email protected] Mahadevan, MD, PhDEmory Winship Cancer InstituteAtlanta, GA USAAlmelida Rene [email protected] Harvey, [email protected] Harris, MDIndiana University SimonCancer CenterIndianapolis, IN USAMary Jane Waddell, RN, [email protected] M Funke, [email protected]. Gabriela Chiorean, MD

AUY922Phase I-II Study to Determine the

Maximum Tolerated Dose (MTD) ofAUY922 in Advanced Solid

Malignancies, and Efficacy in HER2Phase: 1

Novartis Pharmaceuticals1 800 340-6843






Site Name unknown, BellinzonaBellinzona, Switzerland

David Geffen School of Medicine at UCLALos Angeles, CA [email protected] Britten, M.D.

10

Medical College of GeorgiaAugusta, GA [email protected] Samuel, M.D.Dana Farber Cancer InstituteBoston, MA USA617 [email protected] Hodi, MD, PhDWashington University School of MedicineSt. Louis, MO [email protected] Pluard, MDNevada Cancer InstituteLas Vegas, NV USASandy Lahr(702) 822-5174Nicholas Vogelzang, MDMD Anderson Cancer CenterHouston, TX USA800-392-1611 (in U.S.A.)713-792-6161 (outside U.S.A.)Jon Trent, MD, PhDCancer Therapy and Research CenterSan Antonio, TX [email protected] Mita, M.D.

BGT226A Phase I/II Study of BGT226 in

Adult Patients With Advanced SolidMalignancies Including Patients With Advanced Breast CancerPhase: 1

Novartis




800 340-6843


Drug Type: mTOR inhibitorPI3K inhibitor

Princess Margaret HospitalToronto, ON CanadaLillian Siu, M.D.Hospital Vall d'HebronBarcelona, Spain

Dana Farber Cancer InstituteBoston, MA USAMelissa Hohos617 [email protected] Demetri, MD, PhDMassachusetts General HospitalBoston, MA [email protected] Isakoff, MDNevada Cancer InstituteLas Vegas, NV USA Dianna Tercan(702) 822-5483Lin-Chi Chen, M.D., Ph.D.Cancer Therapy and Research CenterSan Antonio, TX USAEpp Goodwin210-450-5798Francis Giles, MD

MP470Safety Study to Determine the

Maximum Tolerated Dose, Pharmacokinetics and

Pharmacodynamics of Oral MP470,Phase: 1

SuperGenGil Fine, [email protected] Mittan, CLS925-560-0100



Strategy: Block KIT



TGen Clinical Research ServicesScottsdale, AZ USARaoul Tibes, MDSouth Texas Accelerated Research Therapeutics (START)San Antonio, TX USAJim Agnew, RNAnthony Tolcher, MD

SNX-5422SNX-5422 in Treating Patients WithSolid Tumor or Lymphoma That Has

Not Responded to TreatmentPhase: 1






Warren Grant MagnusonClinical CenterBethesda, MD USAClinical Trials Office 888-NCI-1937Giuseppe Giaccone, MD, PhD

Vorinostat + BortezomibVorinostat and Bortezomib in

Treating Patients With Metastatic orUnresectable Solid Tumors

Phase: 1



Strategy: Inhibit protein translation + Unblock cell death genes


Drug Type: HDAC inhibitor + Proteasome inhibitor

Carbone Cancer Center, University of WisconsinMadison, WI USAClinical Trials Office608-262-5223George Wilding, MD

11

AMG 479 + AMG 655AMG 655 in Combination With AMG

479 in Advanced, Refractory Solid Tumors

Phase: 2

Amgen Call Center866-572-6436



Strategy: Block related tumor signal paths


Drug Type: IGF1R inhibitor + TNF Inhibitor

Site name unknown, Barcelona 08036Barcelona, Spain

Site name unknown, SantaMonica 90403Santa Monica, CA USA

University of ChicagoChicago, IL USAClinical Trials Office, 773-834-7424Hedy Kindler, MDSite name unknown, IndianapolisIndianapolis, IN USA

Site name unknown, DetroitDetroit, MI USA

AT13387Phase 1 Study of HSP90 inhibitor

AT13387 in solid tumorsPhase: 1

Andrew [email protected]






Beth Israel Deaconess Medical CenterBoston, MA USASue Gotthardt RN, OCN(617) 632-9272Bruce Dezube M.D.Massachusetts General HospitalBoston, MA USAEunice Kwak, MDDana Farber Cancer InstituteBoston, MA USAGeoffrey Shapiro, MD, PhD

BAY 73-4506Phase I study of BAY 73-4506Phase: 1



NCT #:Contact:

Strategy: Block KIT


Drug Type: KIT/PDGFRA inhibitorVEGFR inhibitor (TKI)

MD Anderson Cancer CenterHouston, TX USAClinical Trials Office713-792-3245Jon Trent, MD, PhDSouth Texas Accelerated Research Therapeutics (START)San Antonio, TX USATracy Dufresne, [email protected]

BEZ235A Phase I/II Study of BEZ235 in Patients With Advanced Solid

Malignancies Enriched by PatientsWith Advanced Breast CancerPhase: 1

Novartis




862-778-8300



Nevada Cancer InstituteLas Vegas, NV USADianna Tercan(702) 822-5483Wolfram Samlowski, M.D.Sarah Cannon Research InstituteNashville, TN [email protected] A. Burris, III MD

BIIB021 (CNF2024) Once or Twice Daily Administration

of BIIB021 to Subjects With Advanced Solid Tumors

Phase: 1







Premier Oncology, SantaMonicaSanta Monica, CA USA

South Texas Accelerated Research Therapeutics (START)San Antonio, TX USA

12

BIIB022Phase 1 Study of BIIB022 (Anti-IGF

-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors

Phase: 1






Drug Type: IGF1R inhibitor

Site name unknown, Los Angeles, CALos Angeles, CA USA

University of ColoradoAurora, CO USASarah [email protected] LeongFox Chase Cancer CenterPhiladelphia, PA USAKathleen Lear, RN, OCN, CCRP Phone: 215-214-1511Email: [email protected] Cohen, MD

BKM120A Phase IA, Multi-Center, Open-Label, Dose- Escalation Study of

BKM120, Administered Orally on aContinuous Daily Dosing Schedule

Phase: 1



NCT #:Contact:




Sarah Cannon Research InstituteNashville, TN USA615-329-SCRI (7274)

BMS-754807Multiple Dose Study In Cancer

Patients: Safety and Tolerability of BMS-754807 in Advanced or

Metastatic Solid TumorsPhase: 1

For site information outside the USA please email:

[email protected] line of email MUST contain NCT# & Site#.






Site name unknown, EastMelbourneEast Melbourne, AustraliaSite # 003

Site name unknown, Footscray, AustraliaFootscray, Victoria AustraliaSite # 004

Site name unknown, Heidelberg AustraliaHeidelberg, Victoria AustraliaSite # 002

Site name unknown, Parkville, AustraliaParkville, Victoria AustraliaSite #001

Cixutumumab + Temsirolimus

Cixutumumab and Temsirolimus in Treating Young Patients With SolidTumors That Have Recurred or Not

Responded to TreatmentPhase: 1





Drug Type: IGF1R inhibitor + mTOR Inhibitor

Children's Hospital of Orange CountyOrange, CA USAViolet Shen714-532-8636

Children's National Medical CenterWashington, DC USAClinical Trials Office202-884-2549

Masonic Cancer Center atUniversity of MinnesotaMinneapolis, MN USAClinical Trials Office612-624-2620

Cincinnati Children's Hospital Medical CenterCincinnati, OH USAClinical Trials Office513-636-2799

13

GDC-0941A Study of GDC-0941 in Patients

With Locally Advanced or MetastaticSolid Tumors for Which Standard Therapy Either Does Not Exist or

Phase: 1







TGen Clinical Research ServicesScottsdale, AZ USALynne [email protected] D. Hoff, MDDana Farber Cancer InstituteBoston, MA USAMelissa Hohos617 [email protected] Demetri, MD, PhDKarmanos Cancer InstituteDetroit, MI USAJie [email protected]

GDC-0941A Study of GDC-0941 in Patients

With Locally Advanced or MetastaticSolid Tumors or Non-Hodgkin's Lymphoma for Which Standard

Phase: 1







Royal Marsden HospitalLondon, UKKrunal Shah0208 722 [email protected]

IMC-A12 + CCI-779IMC-A12 in Combination With

Temsirolimus (CCI-779) in PatientsWith Advanced Cancers

Phase: 1

Aung Naing, MD713-563-0181






Karmanos Cancer InstituteDetroit, MI USAall (800) KARMANOS (1-800-527-6266) or e-mail [email protected].

MD Anderson Cancer CenterHouston, TX USA713-563-0181Aung Naing, MD

IMC-A12 + CCI-779Monoclonal Antibody IMC-A12 andTemsirolimus in Treating Patients

With Locally Advanced or MetastaticCancer

Phase: 1






MD Anderson Cancer CenterHouston, TX USAClinical Trials Office - M.D.Anderson Cancer Center, 713-792-3245Aung Naing, MD

IPI-493A Phase I Dose Escation Study of IPI

-493Phase: 1







Premier Oncology, ScottsdaleScottsdale, AZ USAPatricia Shannon, RN480 860-5000 xt [email protected] Mendelson, M.D.San Deigo Pacific Oncologyand Hematology AssociatesEncinitas, CA USAKaren Brady, RN MSN 760-752-3340 [email protected] Just, M.D.Premier Oncology, SantaMonicaSanta Monica, CA USAMarilyn Mulay, NP310-633-8400 [email protected] Rosen M.D.University of ColoradoAurora, CO USAStacy Grolnic, [email protected] Weekes, MD, PhDMary Crowley Medical Research Center (CentralOffice)Dallas, TX USAKay Easterwood-Sanchez214-658-1943Neil Senzer, MD

14

KW2450Safety Study to Evaluate KW-2450 inSubjects With Advanced Solid Tumor

Phase: 1

Danyel Davis(609) [email protected] Rao(609) 919-1100nrao@kyowa-kirin-pharma.






Memorial Sloan-KetteringCancer CenterNew York, NY USA

MEDI-573A Dose-Escalation Study to Evaluate

the Safety, Tolerability, and Antitumor Activity of MEDI-573 in

Subjects With Advanced Solid Phase: 1

Jill [email protected] [email protected]






Mayo Clinic, JacksonvilleJacksonville, FL USAMichele [email protected] E. Menefee, MD

Karmanos Cancer InstituteDetroit, MI USAKaren [email protected] LoRusso, DOMayo Clinic, RochesterRochester, MN USAJanet Lensing507-284-3137 [email protected] Haluska, MD, PhD

OSI-906Phase 1 Study of Continuous OSI

-906 DosingPhase: 1

OSIP Medical Information800.572.1932, [email protected]






Beatson West of ScotlandCancer CentreGlasgow, UK

Vanderbilt-Ingram CancerCenterNashville, TN USA

OSI-906Phase 1 Study of Intermittent OSI

-906 DosingPhase: 1

OSIP Medical Information800.572.1932 ext [email protected]






Department of Cancer Therapeutics, Institute of Cancer ResearchSutton, Surrey UK

MD Anderson Cancer CenterHouston, TX USAEdward Kim, MD

PX-478Phase I Trial of PX-478

Phase: 1




Strategy: Block related tumor signal pathsBlock tumor blood vessel


Drug Type: HIF-1α inhibitor

TGen Clinical Research ServicesScottsdale, AZ USALynne [email protected] D. VonHoff, MDMD Anderson Cancer CenterHouston, TX USAHala Abdulkadir713-792-9944 [email protected] S. Herbst, PhD

15

PX-866Phase I Trial of Oral PX-866Phase: 1







University of ColoradoAurora, CO USASharon [email protected] Jimeno, MDMD Anderson Cancer CenterHouston, TX USARhonda Clement713-563-3559 [email protected] Herbst, MD

R1507A Multiple Ascending Dose Study ofR1507 in Children and Adolescents

With Advanced Solid TumorsPhase: 1

Hoffmann-La RochePlease reference Study ID Number: NO21200973-235-5000800-526-6367 (US only)






Site name unknown, Denver 80218Denver, CO USA

Site name unknown, Bethesda 20982Bethesda, MD USA

Memorial Sloan-KetteringCancer CenterNew York, NY USA212-639-8267Dr. Tanya Trippett

University of PennsylvaniaPhiladelphia, PA USA

MD Anderson Cancer CenterHouston, TX USA800-392-1611 Patients800-392-1611 Referring MDCynthia E. Herzog

SNX-5422Safety and Pharmacology of SNX-5422 Mesylate in Subjects With

Refractory Solid Tumor Malignancies

Phase: 1

Pfizer Oncology Clinical Trial Information1-877-369-9753PfizerCancerTrials@emergingmed.comPfizer CT.gov Call Center1-800-718-1021






TGen Clinical Research ServicesScottsdale, AZ USAJoyce Ingold [email protected] D. Von Hoff, MDSarah Cannon Research InstituteNashville, TN USAJessica Gilbert615 329-7238Howard A. Burris, III MD

SNX-5422Safety Study Of SNX-5422 To Treat

Solid Tumor Cancers And Lymphomas

Phase: 1

Pfizer Oncology Clinical Trial Information [email protected] CT.gov Call Center1-800-718-1021






Site name unknown, Bethesda 20982Bethesda, MD USA

Sorafenib + VorinostatPhase I Vorinostat + Sorafenib in

Patients With Advanced Solid Tumors

Phase: 1




Strategy: Block KIT + Unblock cell death genes + Destroy KIT


Drug Type: HDAC inhibitor + KIT/PDGFRA inhibitor

University of ColoradoAurora, CO USAStacy [email protected] Ross Camidge MD

16

STA-9090Study of STA-9090, Administered

Once-Weekly in Patients With SolidTumors

Phase: 1







Premier Oncology, SantaMonicaSanta Monica, CA USA310-633-8400Lee Rosen, MDUS Oncology - Dayton Oncology & HematologyKettering, OH [email protected](937)293-1622Robert Raju, MD

STA-9090Study of STA-9090, Administered

Twice-Weekly in Patients With SolidTumors

Phase: 1







Dana Farber Cancer InstituteBoston, MA USAMelissa Hohos, RN,617-632-2201Geoffrey Shapiro, MD, PhDMassachusetts General HospitalBoston, MA USAPilar De La Roche Mur617-632-5841

Beth Israel Deaconess Medical CenterBoston, MA USAPilar De La Roche Mur617-632-5841

Karmanos Cancer InstituteDetroit, MI USADr. Patricia LoRusso313-576-8716

,

Sunitinib + CP-751,871Phase 1 Study of CP-751,871 in Combination With Sunitinib in Patients With Advanced Solid

TumorsPhase: 1

EmergingMed(877) [email protected] CT.gov Call Center1-800-718-1021



Strategy: Block KIT + Block related tumor signal paths


Drug Type: KIT/PDGFRA inhibitor + IGF1R inhibitor

Premier Oncology, SantaMonicaSanta Monica, CA USA310 633-8400Lee RosenSouth Texas Accelerated Research Therapeutics (START)San Antonio, TX USA

XL147Study of the Safety and

Pharmacokinetics of XL147 in AdultsWith Solid Tumors

Phase: 1

Exelixis Contact Line




866-939-4041



Hospital Vall d'HebronBarcelona, SpainGemma Sala+34 93 489 4158 [email protected] Baselga, MD, PhDDana Farber Cancer InstituteBoston, MA USAPilar de la Rocha [email protected] Shapiro, MDMary Crowley Medical Research Center (Baylor)Dallas, TX USAJ.R. Dolan214-658-1943Gerald Edelman MD, PhD

XL228Study of XL228 Administered Intravenously to Subjects With

Advanced MalignanciesPhase: 1

Exelixis Contact Line1-866-939-4041






UCLA's Jonsson Comprehensive Cancer CenterLos Angeles, CA USALisa Yonemoto310-825-4477Carolyn Britten, MD

17

University of MichiganAnn Arbor, MI USANabeela Iqbal734-232-0759David Smith, MDDuke UniversityDurham, NC USASharon Norman919-681-5257Herb Horowttz, MD

XL765Study of the Safety and

Pharmacokinetics of XL765 in AdultsWith Solid Tumors

Phase: 1

Exelixis Contact Line




866-939-4041



Hospital Vall d'HebronBarcelona, SpainGemma Sala +34 93 489 4158 [email protected] Baselga, MD, PhDKarmanos Cancer InstituteDetroit, MI USATheresa Laeder 313-576-9386Patricia LoRusso, DOSouth Texas Accelerated Research Therapeutics (START)San Antonio, TX USAGina Mangold, MBA 210-413-3594 [email protected] Papadopoulos, MD

PalliativeTreatment Stage:

RadiationRadiation Therapy as Palliative Treatment of GIST (GIST-RT)Phase: 1




Strategy: Radiation

Stage: Palliative

Drug Type: None

Helsinki University CentralHospitalHelsinki, Finland947173208 Ext. [email protected] Joensuu, MD

Sunitinib + RadiationSutent and Radiation as Treatment

for Limited Extent Metastatic CancerPhase: 2


Conditions: Any type of Cancer


Strategy: Block KIT

Stage: Palliative


Mount Sinai School of MedicineNew York, NY [email protected] Kao, MD

Stable DiseaseTreatment Stage:

ImatinibA phase III randomized study evaluating surgery of residual

disease in patients with metastatic gastro-intestinal stromal tumor

Phase: 3

Anne KirkpatrickProject Manager - EORTC, Brussels, [email protected]+32 2 7741691


NCT #:Contact:

Strategy: Block KIT

Stage: Stable Disease


Netherlands Cancer Institute - Antoni van Leeuwenhoek HospitalAmsterdam, Netherlands

18

july 2009 ct - gist support group & information center … jim hughes lrg clinical trials...

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