SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With Selected FGFR Gene Alterations

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With Selected FGFR Gene Alterations


  • Org Study ID: CR108445
  • Secondary ID: 2017-001980-19,42756493BLC2002
  • NCT ID: NCT03473743
  • NCT Alias:
  • Sponsor: Janssen Research & Development, LLC - Industry
  • Source: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to identify the recommended Phase 2 dose (RP2D) and schedule of erdafitinib in combination with JNJ-63723283 (Phase 1b) and to evaluate the safety and clinical activity of erdafitinib alone and in combination with JNJ-63723283 (Phase 2).

Detailed Description


This open-label (all people know identity of intervention) and multicenter (when more than
one hospital or medical school team work on a medical research study) study of erdafitinib
plus JNJ-63723283 in participants with advanced urothelial cancer with selected fibroblast
growth factor receptor (FGFR) gene alterations who have progressed on or after one or more
prior lines of systemic therapy, will consists of 2 parts. Part 1 (Phase 1b: Dose Escalation)
will establish recommended Phase 2 dose (RP2D) for erdafitinib in combination with
JNJ-63723283, and Part 2 (Phase 2: Dose Expansion) will evaluate safety and efficacy of RP2D.
The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up
phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics,
immunogenicity, biomarkers, and safety.

Overal Status Start Date Phase Study Type
Recruiting April 5, 2018 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Phase 1b: Percentage of Participants with Dose-Limiting Toxicity (DLT)

Primary Outcome 1 - Time Frame: Approximately up to 8 weeks

Primary Outcome 2 - Measure: Phase 1b: Number of Participants with Adverse Events (AEs)

Primary Outcome 2 - Time Frame: Approximately up to 2 years

Primary Outcome 3 - Measure: Phase 2: Overall Response Rate (ORR) (Partial Response [PR] or Better) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Primary Outcome 3 - Time Frame: Approximately up to 2 years

Primary Outcome 4 - Measure: Phase 2: Number of Participants with AEs

Primary Outcome 4 - Time Frame: Approximately up to 2 years

Condition:

  • Urothelial Carcinoma

Eligibility

Criteria:
Inclusion Criteria:

- Histologic demonstration of transitional cell carcinoma of the urothelium. Minor
components (less than [<] 50 percent [%] overall) of variant histology such as
glandular or squamous differentiation, or evolution to more aggressive phenotypes such
as sarcomatoid or micropapillary change are acceptable

- Stage IV disease

- Documented progression of disease per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1, defined as any progression that requires a change in treatment, prior to
randomization

- Prior systemic therapy: (a) Phase 1b: Any number of lines of prior therapy; (b) Phase
2: Progressed after 1 or 2 lines of prior chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: 0 or 1

Exclusion Criteria:

- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b,
participants who have received the following prior antitumor therapy: received
nitrosoureas and mitomycin C within 6 weeks

- Chemotherapy within 3 weeks of Cycle 1 Day 1

- Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1),
or anti-programmed death ligand-2 (PD-L2) therapy

- Active malignancies (that is, requiring treatment change in the last 24 months) other
than urothelial cancer (except skin cancers within the last 24 months that are
considered completely cured)

- Symptomatic central nervous system metastases
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Study Contact

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

Link: To learn how to participate in this trial please click here.

Locations

Facility Status Contact
Rocky Mountain Cancer Centers
Aurora, Colorado 80012
United States
Recruiting
University of Iowa Hospital and Clinic
Iowa City, Iowa 52242
United States
Withdrawn
Maryland Oncology Hematology, PA
Rockville, Maryland 20850
United States
Recruiting
Nevada Cancer Institute
Las Vegas, Nevada 89169
United States
Withdrawn
Weill Cornell Medical College
New York, New York 10029
United States
Recruiting
Practice Dr Dan Costin
White Plains, New York 10601
United States
Not yet recruiting
Toledo Clinic Cancer Centers
Toledo, Ohio 43623-3536
United States
Not yet recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United States
Withdrawn
Penn State Hershey Cancer Institute
Hershey, Pennsylvania 17033
United States
Not yet recruiting
Texas Oncology, P.A.
Fort Worth, Texas 76104
United States
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Recruiting
Gomel Regional Clinical Hospital
Gomel, 246012
Belarus
Not yet recruiting
Grodno Regional Clinical Hospital
Grodno, 230017
Belarus
Not yet recruiting
Minsk city Clinical Oncological Dispensary
Minsk, 220013
Belarus
Not yet recruiting
Cliniques Universitaires Saint-Luc
Brussel, 1200
Belgium
Recruiting
Az Groeninge
Kortrijk, 8500
Belgium
Not yet recruiting
CHU de Liège - Domaine Universitaire du Sart Tilman
Liege, 4000
Belgium
Not yet recruiting
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas, 9100
Belgium
Not yet recruiting
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, 2610
Belgium
Recruiting
Institut de Cancerologie de Ouest (ICO) Site Paul Papin
Angers Cedex 02, 49055
France
Not yet recruiting
Hopital Saint André
Bordeaux, 33075
France
Not yet recruiting
Centre Hospitalier
La Roche Sur Yon, 85925
France
Not yet recruiting
Centre hospitalier Saint Louis
La Rochelle Cedex 1, 17019
France
Not yet recruiting
Centre Leon Bérard
Lyon, 69008
France
Not yet recruiting
Institut Paoli-Calmettes
Marseille Cedex 09, 13273
France
Not yet recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
France
Not yet recruiting
Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
Reims, 51092
France
Not yet recruiting
Clinique Sainte Anne
Strasbourg, 67000
France
Not yet recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31000
France
Not yet recruiting
Institut de Cancérologie de Lorraine
Vandoeuvre Lès Nancy, 54519
France
Not yet recruiting
Institut Gustave Roussy
Villejuif, 94805
France
Not yet recruiting
LTD 'Aversi Clinic'
T'Bilisi, 0160
Georgia
Not yet recruiting
Institute for Personalized Medicine LTD
Tbilisi, 0186
Georgia
Not yet recruiting
Research Institute of Clinical Medicine
Tbilisi, 112
Georgia
Not yet recruiting
LTD Mammological Center Named after K Madichi
Tblisi, 0159
Georgia
Not yet recruiting
Cliniche Humanitas Gavazzeni
Bergamo, 24125
Italy
Not yet recruiting
Istituto di Candiolo, IRCCS
Candiolo, 10060
Italy
Not yet recruiting
UOS Oncologia Medica, A.O. Cannizzaro
Catania, 95126
Italy
Not yet recruiting
P.O. Ss. Annunziata
Chieti Scalo, 66013
Italy
Not yet recruiting
Arcispedale S. Anna Ferrara
Ferrara, 44124
Italy
Not yet recruiting
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
Lecco, 23900
Italy
Not yet recruiting
IRCCS Ospedale San Raffaele
Milano, 20132
Italy
Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
Italy
Not yet recruiting
AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto
Piacenza, 29121
Italy
Not yet recruiting
Azienda USL Toscana Nord Ovest
Pontedera (Pi), 56025
Italy
Not yet recruiting
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123
Italy
Not yet recruiting
Campus Bio-Medico di Roma
Roma, 00128
Italy
Not yet recruiting
Azienda Socio Sanitaria Territoriale (ASST) della Valtellin
Sondrio, 23100
Italy
Not yet recruiting
Azienda Ospedaliera S. Maria Terni
Terni, 05100
Italy
Not yet recruiting
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine, 33100
Italy
Not yet recruiting
Chonnam National University Hospital
Gwangju, 61469
Korea, Republic of
Not yet recruiting
Chonnam National University Hwasun Hospital
Jeonnam, 58128
Korea, Republic of
Not yet recruiting
CHA Bundang Medical center, CHA University
Seongnam, 13496
Korea, Republic of
Not yet recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Korea, Republic of
Not yet recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic of
Not yet recruiting
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591
Korea, Republic of
Not yet recruiting
SMG - SNU Boramae Medical Center
Seoul, 07061
Korea, Republic of
Not yet recruiting
The Catholic University of Korea St. Vincent's Hospital
Suwon-Si, 16247
Korea, Republic of
Not yet recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Korea, Republic of
Not yet recruiting
GUZ Kursk Regional Oncology Dispensary
Kislino Village, Ryshkovsky Ru, 305524
Russian Federation
Not yet recruiting
Leningrad Regional Oncology Dispensary
Kuzmolovsky, 188663
Russian Federation
Not yet recruiting
Clinical Hospital #122 n.a. after L.G. Sokolov
Saint Petersburg, 194291
Russian Federation
Not yet recruiting
City Polyprofiled Hospital #2
Saint Petersburg, 194354
Russian Federation
Not yet recruiting
Clinical and research Oncological Center
Saint Petersburg, 197758
Russian Federation
Not yet recruiting
City Pokrovskaya Hospital
St Petersburg, 199106
Russian Federation
Not yet recruiting
GBUZ 'Regional clinical oncologic dispensary of Volgograd'
Volgograd, 400138
Russian Federation
Not yet recruiting
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
Spain
Not yet recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Spain
Not yet recruiting
Hosp. Clinico San Carlos
Madrid, 28040
Spain
Not yet recruiting
Hosp. Univ. Fund. Jimenez Diaz
Madrid, 28050
Spain
Recruiting
Hosp. Univ. Hm Sanchinarro
Madrid, 28050
Spain
Recruiting
Corporacio Sanitari Parc Tauli
Sabadell, 08208
Spain
Not yet recruiting
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Spain
Not yet recruiting
H. Clinico Universitario de Santiago de Compostela
Santiago De Compostela, 15706
Spain
Not yet recruiting
Hosp. Virgen Macarena
Sevilla, 41009
Spain
Not yet recruiting
Hosp. Virgen Del Rocio
Sevilla, 41013
Spain
Recruiting
Instituto Valenciano de Oncologia
Valencia, 46009
Spain
Not yet recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United Kingdom
Not yet recruiting
Royal Lancaster Infirmary
Lancaster, LA1 4rp
United Kingdom
Not yet recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
United Kingdom
Not yet recruiting