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CTRI Number  CTRI/2021/08/036009 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 06/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study is to evaluate recurrence-free survival in participants with high-risk non-muscle-invasive bladder cancer who harbor fibroblast growth factor receptor mutationor infusion and who recurred after bacillus calmette-guerin therapy treated with erdafitinib. 
Scientific Title of Study   A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions 
Trial Acronym  THOR 2 
Secondary IDs if Any  
Secondary ID  Identifier 
2019-002449-39  EudraCT 
42756493BLC2003  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanish Davis 
Designation  R and D Director GCO India 
Affiliation  Johnson and Johnson Private Limited 
Address  Arena Space Behind Majas Depot Off J V Link Road Jogeshwari East Mumbai Maharashtra 40060 India

Mumbai
MAHARASHTRA
40060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanish Davis 
Designation  R and D Director GCO India 
Affiliation  Johnson and Johnson Private Limited 
Address  Arena Space Behind Majas Depot Off J V Link Road Jogeshwari East Mumbai Maharashtra 40060 India

The Dangs
MAHARASHTRA
40060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanish Davis 
Designation  R and D Director GCO India 
Affiliation  Johnson and Johnson Private Limited 
Address  Arena Space Behind Majas Depot Off J V Link Road Jogeshwari East Mumbai Maharashtra 40060 India

The Dangs
MAHARASHTRA
40060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Source of Monetary or Material Support  
Johnson & Johnson Private Limited LBS Marg Mulund West Mumbai 400080 Address for correspondence: Arena Space, Behind Majas Bus Depot, Off J.V. Link Road, Jogeshwari (E),Mumbai - 400060 
 
Primary Sponsor  
Name  Janssen Research Development LLC 
Address  Johnson and Johnson Private Limited Arena Space, Off J V Link Road Behind Majas Depot Jogeshwari East Mumbai 40060 Maharashtra India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Belgium
Brazil
China
Czech Republic
France
Germany
India
Italy
Japan
Poland
Spain
United Kingdom
United States of America
Taiwan  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajendra Shimpi  Inamdar Multispecialty Hospital  Survey No 15 Fatima Nagar Pune - 411040
Pune
MAHARASHTRA 		 9822059799

rajendrakshimpi@gmail.com 
Dr Ravichandran Ramaswamy   Meenakshi Mission Hospital and Research Center  Clinical Research Department, Research room, Lake Area, Melur Road Madurai-625107 India
Madurai
TAMIL NADU 		 9442648266

drravi1962@gmail.com 
Dr Mahesh Desai   Muljibhai Patel Urological Hospital  Uro research Department, Clinical Research division, Ground Floor, Dr Vijendra Desai Road, Nadiad-387001 India
Surat
GUJARAT 		 9824028041

mrdesai@mpuh.org 
Dr Sudhir Rawal   Rajiv Gandhi Cancer Institute and Research Centre   Department of Clinical Research, Room no. 2261, second Floor, New Building Sector 5 Rohini Delhi 110085 India
North West
DELHI 		 9810139757

sudhirrawal85@gmail.com 
Dr Ganesh Bakshi   Tata Memorial Hospital  Department of Medical Oncology, Room no 304, 3rd floor. HBB Bock, Dr E Borges Road, Parel - 400012 India
Mumbai (Suburban)
MAHARASHTRA 		 9869331584

gkbakshi73uro@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics committee Inamdar Multispeciality Hospital  Approved 
Institutional Ethics committee   Approved 
Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre   Submittted/Under Review 
Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee   Approved 
TMH, Institutional Ethics Committee   Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erdafitinib  Participants will receive 8mg erdafitinib daily dose orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days. 
Comparator Agent  Investigator Choice (Gemcitabine)  Intravesical gemcitabine 2000mg administered once weekly for at least 4 doses of induction and then monthly for at least 6 months. 
Comparator Agent  Investigator Choice (Mitomycin C)  Intravesical mitomycin C 40 mg will be administered once weekly for at least 4 doses of induction and than for at least 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  - Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
- Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
- Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
- Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
- Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- A woman of childbearing potential must have a negative pregnancy test (beta-hCG [beta-human chorionic gonadotropin]) (urine or serum) within 7 days before randomization (Cohort 1) or
the first dose of study drug (Cohort 2 and Cohort 3)
- Adequate bone marrow, liver, and renal function as specified in the protocol 
 
ExclusionCriteria 
Details  - Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder
- Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder
- Prior treatment with an FGFR inhibitor
- Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
- Current central serous retinopathy or retinal pigment epithelial detachment of any grade 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Recurrence-Free Survival (RFS)  Recurrence-Free Survival (RFS) 
 
Secondary Outcome  
Outcome  TimePoints 
Time to Disease Worsening  Up to 4 years 
Time to Progression  Up to 4 years 
Disease-Specific Survival  Up to 4 years 
Overall Survival  Up to 4 years 
Recurrence-Free Survival  Months 6, 12, and 24 
Recurrence-Free Survival 2 (RFS2)  Up to 4 years 
RFS by Central Histopathologic Review  Up to 4 years 
Plasma Concentration of Erdafitinib  Cycle 1 Day 14, Cycle 2 Day 1 (each cycle is of 28
days) 
Number of Participants with Adverse events  Up to 4 years 
Change from Baseline in Patient’s Global
Impression of Severity (of cancer) (PGIS) 		 Baseline up to 4 years 
Change from Baseline in Patient’s Global
Impression of Change (of cancer) (PGIC) 		 Baseline, Cycle 2 Day 1 and end of treatment (up to
2 years) (each cycle is of 28 days) 
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life
Questionnaire (EORTC QLQ) -C30 		 Baseline up to 4 years 
Change from Baseline in EORTC QLQ- Non-
Muscle-Invasive Bladder Cancer (NMIBC) 24 		 Baseline up to 4 years 
Change from Baseline in EuroQol European Quality
of Life – 5 Dimensions-5 Levels (EQ-5D-5L) 		 Baseline up to 4 years 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="23" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/02/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="6"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.
 
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