JOURNAL ONKOLOGIE – STUDIE
An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer
Rekrutierend
NCT-Nummer:
NCT02365597
Studienbeginn:
April 2015
Letztes Update:
19.07.2021
Wirkstoff:
Erdafitinib, Midazolam, Metformin
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Janssen Research & Development, LLC
Collaborator:
-
Studienleiter
Study Director
Janssen Research & Development, LLC
Kontakt
Kontakt:
E-Mail: JNJ.CT@sylogent.com» Kontaktdaten anzeigen
Studienlocations
(3 von 152)
Nordallee 1
54292 Trier
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10967 Berlin
(Berlin)
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91054 Erlangen
(Bayern)
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45136 Essen
(Nordrhein-Westfalen)
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60590 Frankfurt
(Hessen)
GermanyZurückgezogen» Google-Maps
79106 Freiburg
(Baden-Württemberg)
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Ferdinand-Sauerbruch-Straße
17475 Greifswald Greifswald
(Mecklenburg-Vorpommern)
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37075 Göttingen
(Niedersachsen)
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22763 Hamburg
(Hamburg)
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30625 Hannover
(Niedersachsen)
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69120 Heidelberg
(Baden-Württemberg)
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81675 Muenchen
(Bayern)
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48129 Muenster
(Nordrhein-Westfalen)
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93053 Regensburg
(Bayern)
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St.-Elisabeth-Straße 23
94315 Straubing
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92637 Weiden/Opf
(Bayern)
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85259 Scottsdale
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86336 Sedona
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85724 Tucson
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94904 Greenbrae
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90048 Los Angeles
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90095 Los Angeles
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92868 Orange
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95817 Sacramento
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94305 Stanford
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80012 Aurora
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20007 Washington
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60611 Chicago
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60637 Chicago
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52242 Iowa City
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40202 Louisville
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48109 Ann Arbor
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48201 Detroit
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55404 Minneapolis
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68130 Omaha
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89169 Las Vegas
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08903 New Brunswick
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10021 New York
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10065 New York
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28204 Charlotte
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97504 Medford
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97062 Tualatin
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17033 Hershey
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15232 Pittsburgh
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29572 Myrtle Beach
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37203 Nashville
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75231 Dallas
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75246 Dallas
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75390 Dallas
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76210 Denton
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77024 Houston
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77030 Houston
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23666 Hampton
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53792 Madison
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A-8036 Graz
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4020 Linz
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A-1090 Vienna
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9300 Aalst
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1200 Brussel
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6000 Charleroi
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9000 Gent
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2610 Wilrijk
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49055 ANGERS Cedex
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Bordeaux
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14076 Caen Cédex 05
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21000 Dijon
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69008 Lyon
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06189 Nice Cedex 2
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30029 Nîmes
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75475 Paris Cedex 10
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75908 Paris Cedex 15
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44805 Saint Herblain Cedex
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92150 Suresnes
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31059 Toulouse cedex 09
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94805 Villejuif Cedex
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560027 Bangalore
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160012 Chandigarh
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401107 Mira Road (East)
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387001 Nadiad
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84101 Beer Sheba
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60930 Beer Yaakov
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31096 Haifa
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44281 Kfar-Saba
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49100 Petah Tikva
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64239 Tel-Aviv
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52100 Arezzo
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47014 Meldola
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20100 Milano
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80131 Napoli
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28100 Novara
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10043 Orbassano
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35128 Padova
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43126 Parma
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56126 Pisa
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00152 Roma
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00168 Roma
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00161 Rome
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20089 Rozzano
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10126 Torino
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60126 Torrette Di Ancona
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301-721 Daejeon
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410-769 Goyangsi
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21565 Incheon
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03722 Seoul
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05505 Seoul
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135-710 Seoul
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MD 2025 Chisinau
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050659 Bucharest
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11172 Bucharest
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022328 Bucuresti
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050159 Bucuresti
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400015 Cluj-Napoca
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200385 Craiova
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700483 Iasi
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Timisoara
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656049 Barnaul
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115478 Moscow N/a
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105425 Moscow
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125284 Moscow
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644013 Omsk
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357502 Pyatigorsk
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191104 Saint-Petersburg
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197758 Saint-Petersburg
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450000 Ufa
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Badalona
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08035 Barcelona
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08036 Barcelona
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28006 Madrid
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28007 Madrid
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28020 Madrid
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28034 Madrid
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28041 Madrid
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28046 Madrid
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28050 Madrid
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29010 Málaga
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31008 Pamplona
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08208 Sabadell
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39008 Santander
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15706 Santiago de Compostela
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41013 Sevilla
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46010 Valencia
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40705 Taichung
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70403 Tainan
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10002 Taipei
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333 Taoyuan
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BB2 3HH Blackburn
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DD1 9SY Dundee
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RM7 0AG Essex
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W6 8RF London
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PL6 8DH Plymouth
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SM2 5PT Sutton
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CH63 4JY Wirral
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Studien-Informationen
Detailed Description:This is a multicenter, open-label study (participants will know the identity of study drugs
administered) to evaluate the efficacy and safety of erdafitinib in participants with
urothelial cancer. The study comprises a 30-days Screening Phase, a Treatment Phase comprised
of 28-day treatment cycles that will continue until disease progression or unacceptable
toxicity occurs, and a post-treatment Follow-up Phase that will extend from the
End-of-Treatment Visit until the participant has died, withdraws consent, is lost to
follow-up, or the end of the study, whichever comes first. The end of study is defined as the
date when all participants have completed the study treatment (Regimens 1 to 3) or until the
last participant enrolled under the drug-drug interaction (DDI) substudy completes the end of
treatment visit,(whichever happens last). The purpose of DDI sub-study is to evaluate the
interaction of repeated doses of erdafitinib with a sensitive cytochrome 450 (CYP) 3A
substrate (midazolam) and with an organic cation transporter 2 (OCT2) probe substrate
(metformin). Safety will be monitored throughout the study.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Must have histologic demonstration of metastatic or surgically unresectable urothelial
cancer. Minor components of variant histology such as glandular or squamous
differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or
micropapillary change are acceptable
- Must have measurable disease according to the Response Evaluation Criteria in Solid
Tumors (RECIST, version 1.1) at baseline
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1,
or 2
- Must have adequate bone marrow, liver, and renal function as described in protocol
- Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at
Screening for women of child bearing potential who are sexually active
- Must have shown disease progression according to RECIST, version 1.1, following prior
chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants
who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or
progression according to RECIST, version 1.1, within 12 months of the last dose are
considered to have received chemotherapy in the metastatic setting. These participants
will be referred to as chemo-refractory participants. (Participants who have shown
disease progression according to RECIST, version 1.1 following prior treatment with
anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible) For DDI
substudy
- Disease progression following prior chemotherapy for metastatic or surgically
unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant
chemotherapy and showed disease recurrence or progression within 12 months of the last
dose are considered to have received chemotherapy in the metastatic setting.
Exclusion Criteria:
- Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with
an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and
mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the
first administration of study drug. Localized palliative radiation therapy (but should
not include radiation to target lesions) and ongoing bisphosphonates and denosumab,
are permitted
- Has persistent phosphate level greater than upper limit of normal (ULN) during
screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical
management
- Has a history of or current uncontrolled cardiovascular disease
- Females who are pregnant, breast-feeding, or planning to become pregnant within 3
months after the last dose of study drug and males who plan to father a child while
enrolled in this study or within 5 months after the last dose of study drug
- Has not recovered from reversible toxicity of prior anticancer therapy (except
toxicities which are not clinically significant such as alopecia, skin discoloration,
or Grade 1 neuropathy)
Studien-Rationale
Primary outcome:1. Percentage of Participants with Best Overall Response (Time Frame - From the start of the study treatment until the end of treatment (1 year)):
The objective response rate is defined as the percentage of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST v1.1) criteria. Per RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary outcome:
1. Progression-free survival (Time Frame - From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (up to 5 years)):
Progression-free survival is defined as the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience a complete response during the study) or death, whichever comes first.
2. Duration of Response (Time Frame - From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (up to 5 years)):
The duration of response (CR or PR) is defined as the earliest date a participant achieved a complete response (CR) or a partial response (PR), calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
3. Overall survival (Time Frame - From the date of the first dose of study drug until death (up to 5 years)):
Overall survival is defined as the time interval in days between the date of the first dose of study drug and the participant's death from any cause. If the participant is alive or the vital status is unknown, the participant's data will be censored at the date the participant was last known to be alive.
4. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Screening up to end of study (up to 5 years)):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
5. Percentage of Participants With Biomarker Assessment (Time Frame - Baseline up to end of study (up to 5 years)):
Presence of circulating biomarkers (DNA, RNA, or proteins) associated with FGFR aberrations will be observed.
6. Plasma Concentration of Erdafitinib (Time Frame - Baseline up to end of study (up to 5 years))
7. Plasma Clearance of Erdafitinib (Time Frame - Baseline up to end of study (up to 5 years))
8. Volume of Distribution of Erdafitinib (Time Frame - Baseline up to end of study (up to 5 years))
9. Plasma Concentration of Midazolam and its Metabolite (1-OH-midazolam) (Time Frame - Up to 14 days)
10. Plasma Concentration of Metformin (Time Frame - Up to 15 days)
Geprüfte Regime
- Erdafitinib (JNJ-42756493):
8 mg orally once daily for 28 days on a 28 day cycle. - Midazolam:
Participants who enrolled in DDI substudy will receive pretreatment with single dose of midazolam on Day -2 and single dose of midazolam on Day 13. - Metformin:
Participants who enrolled in DDI substudy will receive pretreatment with single dose of metformin on Day -1 and single dose of metformin on Day 14.
Quelle: ClinicalTrials.gov
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