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BRIEF TITLE: Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations

Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations


  • Org Study ID: TPU-TAS-120-101
  • Secondary ID: 2013-004810-16
  • NCT ID: NCT02052778
  • NCT Alias:
  • Sponsor: Taiho Oncology, Inc. - Industry
  • Source: Taiho Oncology, Inc.

Brief Summary

This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2 study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients with advanced solid tumors with and without FGF/FGFR-related abnormalities. The study will be conducted in 3 parts, (1) Dose escalation to determine the MTD and/ or RP2D of TAS-120 in which this part of the study has been completed; (2) Phase 1 expansion to further evaluate the safety and efficacy of RP2D of TAS-120 in patients with tumors harboring specific FGFR aberrations, specifically in patients with cholangiocarcinoma, gliomas , urothelial carcinomas and any other tumors with FGFR fusion or activating mutation or amplification. Up to approximately 185 patients will be enrolled in the phase 1 expansion; and (3) Phase 2 study to confirm ORR of TAS-120 in intra-hepatic CCA patients with tumors harboring FGFR2 gene fusions. Approx. 100 patients will be enrolled in phase 2.

Detailed Description


Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Dec 2017

Phase 1 Dose Expansion: (CLOSED)

Up to approximately 185 patients will be enrolled among the 8 groups as outlined below:

- Group 1- CCA (iCCA or eCCA) with FGFR2 gene fusions.

- Group 2- CCA (iCCA or eCCA) with FGFR2 gene fusions that are chemotherapy naive or
intolerant to first line chemotherapy (i.e., on chemotherapy regimen ≤ 1 cycle).

- Group 3 - CCA (iCCA or eCCA) with FGFR2 gene fusions treated with prior FGFR inhibitors.

- Group 4 - CCA (iCCA or eCCA) with other FGFR2 abnormalities, ie, gene mutations,
rearrangements or amplifications.

- Group 5 - GBM or grade III glioma (i.e, anaplastic astrocytoma or anaplastic
oliogodendroglioma) with FGFR gene fusions or activating mutations

- Group 6 - Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating
mutations.

- Group 7: Basket of tumor types with tumors harboring FGFR2 amplification (≥10 copies).

- Group 8 - Basket of tumor types (except CCA, brain tumors and advanced urothelial
carcinomas) with tumors harboring FGFR gene fusions or activating mutations.

Phase 2:

Approximately 100 iCCA patients with confirmed FGFR2 gene fusions will be treated. Patients
will be centrally screened for FGFR2 gene fusions. This is a Single arm study with the
primary endpoint of ORR.

Overal Status Start Date Phase Study Type
Recruiting Start Date: July 2014 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Phase 1 - Overall Response Rate (ORR)

Primary Outcome 1 - Time Frame: 12 months

Primary Outcome 2 - Measure: Phase 1 - Early Progression Rate (EPR) for GBM or grade III glioma

Primary Outcome 2 - Time Frame: 12 months

Primary Outcome 3 - Measure: Phase 2 - Overall Response Rate (ORR)

Primary Outcome 3 - Time Frame: 12 months

Condition:

  • Cholangiocarcinoma
  • Brain Tumor
  • Urothelial Cancer
  • Other Tumor Types With FGFR2 Gene Fusions
  • Activating Mutations
  • FGFR2 Amplification

Eligibility

Criteria:
Inclusion Criteria:

Has histologically or cytologically confirmed, locally advanced, metastatic cancer meeting
the following criteria:

Phase 1 Expansion

1. Patient has failed all standard therapies or standard therapy does not exist or is not
tolerated.

2. Patient has specific FGF/FGFR aberrations

- Intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 gene fusions or other
FGFR2 abnormalities, i.e., gene mutations (see Appendix A), rearrangements or
amplifications

- Glioblastoma or grade III glioma (i.e., anaplastic astrocytoma or anaplastic
oligodendroglioma) with FGFR gene fusions or activating mutations.

- Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations

- All other tumor types harboring FGF9, FGF19 or FGFR2 amplifications (≥ 10
copies), FGFR gene fusions, or FGFR activating mutations

Phase 2

1. Patient has histologically or cytologically confirmed, locally advanced, metastatic,
unresectable iCCA harboring FGFR2 gene fusions based on results from a NGS assay by
the Sponsor's designated central laboratory

2. Patient has been treated with and failed at least one prior systemic gemcitabine and
platinum-based chemotherapy for the advanced disease

3. Must have documentation of radiographic progression of disease on prior systemic
therapy

4. Patient has measurable disease as defined by Response Evaluation Criteria in Solid
Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or RANO
criteria (2010) for brain tumors.

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

6. Adequate organ function

Exclusion Criteria:

A patient will be excluded from this study if any of the following criteria are met:

1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus
homeostasis.

2. History and/or current evidence of clinically significant ectopic
mineralization/calcification.

3. History and/or current evidence of clinically significant retinal disorder confirmed
by retinal examination.

4. A serious illness or medical condition(s)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jerry Huang, MD

Role: Study Director

Affiliation: Taiho Oncology, Inc.

Overall Contact

Name: Jerry Huang, MD

Phone:

Email: jhuang@taihooncology.com

Locations

Facility Status Contact
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Recruiting Rachel Hungerford, RN
480-256-5423
BMDACCResearch@bannerhealth.com
Mayo Clinic (AZ)
Scottsdale, Arizona 85259
United States
Recruiting Brett Madden
480-342-4800
Madden.brett@mayo.edu
City of Hope National Medical Center
Duarte, California 91010
United States
Recruiting Daneng Li
626-471-9200
danli@coh.org
UCSF - Helen Diller
San Francisco, California 94158
United States
Recruiting Lillian Jahan
415-502-4174
lillian.jahan@ucsf.edu
Mayo Clinic (Jacksonville)
Jacksonville, Florida 32224
United States
Recruiting Evans Pope
904-953-3814
Pope.evans@mayo.edu
Florida Hospital
Orlando, Florida 32804
United States
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Cancer Treatment Centers of America
Newnan, Georgia 30265
United States
Recruiting Becky Slawik
770-400-7191
Becky.slawik@ctca-hope.com
Cancer Treatment Centers of America Zion, IL
Zion, Illinois 60099
United States
Recruiting Maria E Rivas
847-872-4019
maria.rivas@ctca-hope.com
The University of Kansas Cancer Center
Westwood, Kansas 66205
United States
Recruiting LaToya Berry
913-945-8871
lberry4@kumc.edu
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Recruiting Patty Lynch
617-643-0815
lynch.patricia2@mgh.harvard.edu
Cancer Center at Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Recruiting Mary Linton Peters
617-667-2100
mbpeters@bidmc.harvard.edu
Dana Farber Cancer Institution
Boston, Massachusetts 02215
United States
Recruiting GI Clinical Research Line
617-632-5960
Wayne State Universtity (Karmanos Cancer Institute)
Detroit, Michigan 48201
United States
Recruiting Amanda Newman
313-576-8411
newmana@karmanos.org
Mayo Clinic (MN)
Rochester, Minnesota 55905
United States
Recruiting Toni Mangskau
507-538-3365
cancerctr@mayo.edu
New Mexico Cancer Care Alliance
Albuquerque, New Mexico 87106
United States
Recruiting Ursa Brown-Glaberman
505-272-4946
ubrown-glaberman@salud.unm.edu
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Sidney Kimmel Cancer Center at Jefferson
Philadelphia, Pennsylvania 19107
United States
Recruiting Cynthia Perez
215-955-6407
Cynthia.Perez@jefferson.edu
Cancer Treatment Centers of America Philadelphia, PA
Philadelphia, Pennsylvania 19124
United States
Recruiting Paolo Casibang, RN
215-537-6438
ERMC@ctca-hope.com
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
Recruiting Kimberly Auth
412-623-5396
preastk@upmc.edu
Greenville Health System ITOR
Greenville, South Carolina 29605
United States
Recruiting Lisa Johnson
864-455-3600
Ljohnson4@ghs.org
Spartanburg Medical Center
Spartanburg, South Carolina 29303
United States
Recruiting Ken Kuenzli, RN
864-560-7579
kkuenzli@gibbscc.org
Mary Crowley
Dallas, Texas 75251
United States
Recruiting Mary Crowley Cancer Research
972-566-3000
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Funda Meric-Bernstam
713-792-3737
Fmeric@mdanderson.org
Virginia Mason Cancer Center
Seattle, Washington 98101
United States
Recruiting Ryan Sinit
206-341-8945
Ryan.Sinit@virginiamason.org
UW Carbone Cancer Center
Madison, Wisconsin 53792
United States
Recruiting Cancer Connect
608-262-5223
cancerconnect@uwhealth.org
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting Medical College of Wisconsin Clinical Trials office
866-680-0505
_cccto@mcw.edu
Royal Melbourne Hospital
Melbourne,
Australia
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Scientia Clinical Research University of New South Wales
Randwick, 2031
Australia
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Scientia Clinical Research University of New South Wales
Randwick, NSW 2031
Australia
Recruiting Noman Bakhshi
+61 29382 5824
noman.bakhshi@scientiaclinicalresearch.com.au
Institut Bergonie
Bordeaux, 33000
France
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Hospices Civils de Lyon
Bron, 69677
France
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Centre Léon Bérard Bât
Lyon, 69008
France
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Pitié-Salpêtrière Hospital
Paris, 75013
France
Recruiting Marc Sanson
0033142160435
marc.sanson@aphp.fr
Institute Goustave-Roussy
Paris,
France
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Rennes, Centre Eugène Marquis
Rennes cedex, 35042
France
Recruiting Christelle Nicolle
+33 (0)2 99 25 32 64
c.nicolle@rennes.unicancer.fr
The Chinese University of Hong Kong
Sha Tin,
Hong Kong
Recruiting Dr. Stephen Lam Chan
(852) 35052166
l_chan@clo.cuhk.edu.hk
Prince of Wales Hospital
Shatin,
Hong Kong
Recruiting Dr. Stephen Lam Chan
(852) 35052166
chanlam_stephen@cuhk.edu.hk
Nagoya University Hospital
Nagoya, 466-8560
Japan
Recruiting Takashi Mizuno
+81 52744 2222
tmzn@med.nagoya-u.ac.jp
Osaka International Cancer Institute
Osaka, 541-8567
Japan
Recruiting Tatsuya Ioka
06 6945 1181
ioka_ta@hotmail.com
Yonsei University, Severance Hospital (Seoul)
Seoul, 03722
Korea, Republic of
Recruiting Hyun Jung Park
82-2-2228-8054
HJWWJD@yuhs.ac
ASAN Medical Center (Seoul)
Seoul, 05505
Korea, Republic of
Recruiting Su-Young Kim
+82 2 3010 5634
sykim92@amc.seoul.kr
Samsung Medical Center (Seoul)
Seoul, 06351
Korea, Republic of
Recruiting Joon Oh Park, M.D., Ph.D
+82 2 3410 3459
oncopark@skku.edu
Seoul National University Hospital
Seoul, 110-744
Korea, Republic of
Recruiting Dr. Do-Youn Oh
+82 2 2072 0701
ohdoyoun@snu.ac.kr
University of Amsterdam
Amsterdam, 1105AZ
Netherlands
Recruiting HJ Klumpen
+31205665955
Secr-onco@amc.nl
Val D'Hebron University Hospital
Barcelona, 08035
Spain
Recruiting Ignacio Matos
34934894350
imatos@vhio.net
Hospital Clinic i Provincial de Barcelona,
Barcelona, 08036
Spain
Recruiting Dr Javier García-Corbacho
93 2279214
Garcia33@clinic.ub.es
University Hospital Ramón y Cajal
Madrid, 28034
Spain
Recruiting Federico Longo
+34913368263
federico.longo@salud.madrid.org
Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro
Madrid,
Spain
Recruiting Valentina Boni
+34 917567825
Valentina.Boni@start.stoh.com
National Taiwan University Hospital
Taipei, 10048
Taiwan
Recruiting Chih-Hung Hsu
+886 2 2312 3456
chihhunghsu@ntu.edu.tw
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
United Kingdom
Recruiting Dr. Debashis Sarker
+44 20 7188 8103
earlyphaseresearchteam@gstt.nhs.uk
University College London Hospital
London, W1T 7HA
United Kingdom
Recruiting Jerry Huang, MD
609-250-7208
jhuang@taihooncology.com
Sarah Cannon Research Institute
London,
United Kingdom
Recruiting Tobias Arkenau
0203 219 5200
Tobias.Arkenau@HCAHealthcare.co.uk