| CTRI Number |
CTRI/2025/05/086865 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Evaluate the Safety and Effectiveness of Study Drug RP12146 in Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA1/2 mutation |
|
Scientific Title of Study
|
A Phase I/Ib, Multi-center, Randomized, Open-Label Study to Assess the Safety, Tolerability and Anti-tumor Activity of RP12146, a Poly (ADP-ribose) Polymerase (PARP) Inhibitor, in Patients with BRCA1/2 Mutated Metastatic Castration-Resistant Prostate Cancer |
| Trial Acronym |
NA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| protocol no RP12146-2301; Version No. 2.1 dated 06.11.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prajak Barde |
| Designation |
Medical Director |
| Affiliation |
Incozen Therapeutics Pvt Ltd |
| Address |
Manjeera Trinity Corporate, JNTU Road, Kukatpally
Hyderabad
TELANGANA
500072
India |
| Phone |
4066291000 |
| Fax |
|
| Email |
prajakb@incozen.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajak Barde |
| Designation |
Medical Director |
| Affiliation |
Incozen Therapeutics Pvt Ltd |
| Address |
Manjeera Trinity Corporate, JNTU Road, Kukatpally
Hyderabad
TELANGANA
500072
India |
| Phone |
4066291000 |
| Fax |
|
| Email |
prajakb@incozen.com |
|
Details of Contact Person
Public Query
|
| Name |
Mustafa Pardiwala |
| Designation |
Deputy General Manager Clinical Operations |
| Affiliation |
Raptim Research Private Ltd |
| Address |
A-242,A-226, TTC Industrial Area, Near Mahape Depot,Mahape MIDC, Navi Mumbai
Thane
MAHARASHTRA
400710
India |
| Phone |
2268316161 |
| Fax |
|
| Email |
mustafa.pardiwala@raptimresearch.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Fenix Research Labs Private Limited
Manjeera Trinity Corporate, JNTU Road, Kukatpally, Hyderabad-500072, Telangana. India
|
|
Primary Sponsor
Modification(s)
|
| Name |
Fenix Research Labs Private Limited |
| Address |
Manjeera Trinity Corporate, JNTU Road, Kukatpally, Hyderabad-500072, Telangana. India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Raptim Research Private Ltd |
A-242,A-226, TTC Industrial Area, Near Mahape Depot,Mahape MIDC, Navi Mumbai – 400710, India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukul Gharote |
Aayush Multispeciality Hospital |
Surya, Arcade,2nd floor, Opposite
Nimani Bus stand, Panchvati,
422002, India
Nashik
MAHARASHTRA |
8758052774
drmukulgharote.citius@gmail.com |
| Dr Lovenish Goyal |
Addhar Health Institute |
Toshan road, near south bypass
crossing, 125005,
India
Hisar
HARYANA |
9896539142
drlovenish@gmail.com |
| Dr Ranjit Kumar Sahoo |
All India Institute of Medical Sciences (AIIMS), |
Room No. 102, 1st Floor, Old O.T. Block, Ansari Nagar, -110029
New Delhi
DELHI |
9013956187
drranjitmd@gmail.com |
| Dr Saurabh Rajeshwar Prasad |
KIMS Kingsway Hospitals |
SPANV Medisearch Lifesciences Private Limited, 44, Parwana Bhawan, Kingsway, 440001, India
Nagpur
MAHARASHTRA |
9373219772
drsaurabhprasad@gmail.com |
| Dr Viraj Borgaonkar |
Kruspamayi Hospital |
Akshay Opp. Youth Hostel; Near Baba Petrol
Pump; Railway station road; 431001 India
Aurangabad
MAHARASHTRA |
9673073555
virajoncosurg@gmail.com |
| Dr Sandeep Batra |
Max Super Speciality Hospital, Saket |
A unit of Devki Devi Foundation, 2, Press
Enclave Road, Saket- 110017 India
New Delhi
DELHI |
9811035061
Sandeep.Batra@maxhealthcare.com |
| Dr Ananda Selvakumar Pandy |
Meenakshi Mission Hospital and Research Centre |
Lake Area, Melur road, 625107, India.
Madurai
TAMIL NADU |
9894333759
drask81@yahoo.co.in |
| Dr Abhishek Singh Gajendra |
Muljibhai Patel Urological Hospital |
Dr. Virendra Desai Road, Nadiad- 387001, India
Kheda
GUJARAT |
9537264656
drabhisheksingh82@gmail.com |
| Dr Aditya Prakash Sharma |
Post Graduate Institute of Medical Education and Research (PGIMER) |
Sector 12, - 160012, India
Chandigarh
CHANDIGARH |
9592918983
aditya.p.sharma@gmail.com |
| Dr Tushar Vishvasrao Patil |
Sahyadri Super Speciality Hospital |
Deccan Gymkhana Plot No. 30 C, Erandawane, Karve Road, 411004, India
Pune
MAHARASHTRA |
9552522556
tussipats@hotmail.com |
| Dr Amit Joshi |
Tata Memorial Hospital |
Dr. Ernest Borges Road, Tata Memorial Hospital, Parel, 400012, India
Mumbai
MAHARASHTRA |
9769331525
dramitjoshi74@gmail.com |
| Dr Amit Jain |
Valentis Cancer Hospital |
Valentis Cancer Hospital, Mussoorie,
Mawana Road,250001 India
Meerut
UTTAR PRADESH |
9410815252
dramit2001@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Aadhar Health Institute |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committe Krupamayi Hospital |
Approved |
| Institutional Ethics Committee , Meenakshi Mission Hospital and Research Centre |
Approved |
| Institutional Ethics Committee III, TMC ACTREC |
Approved |
| Institutional Ethics Committee Valentis Cancer Hospital |
Approved |
| Institutional Ethics Committee, Devki Devi Foundation |
Approved |
| Institutional Ethics Committee, PGIMER |
Approved |
| Kingsway Hospitals Ethics Committee |
Approved |
| Leelavati Ethics Committee |
Approved |
| Muljibhai Patel Society for Research in Nephro- Urology Ethics Committee |
Approved |
| Sahyadri Hospitals Private Limited Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z192||Hormone resistant malignancy status, (2) ICD-10 Condition: C61||Malignant neoplasm of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
RP12146 100 mg |
Dose Escalation: For first nine patients, two tablets of 100 mg (200 mg) BID and then if no DLT then shift to four tablets of 100 mg (400 mg) BID, to determine Maximum Tolerated Dose (MTD).
Dose Expansion: 15 patients on optimal/MTD dose of RP12146 and 15 patients on one dose lower than optimal/MTD dose of RP12146
RP12146 will be administered orally twice a day (BID) in 28 days of the cycle
Route of administration: Oral
Total duration: Till disease progression or unacceptable toxicity until a maximum duration of 24 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
For Part A
Patients must be greater than equal to 18 years of age or older at the time of signing informed consent
Patients must have histologically and or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC)
Patients must provide informed consent for screening of BRCA1 or BRCA2 mutation status
For Part B
Provision of full informed consent prior to any study-specific procedures.
Patients must be greater than equal to 18 years of age, at the time of signing informed consent.
Patients who have histologically and/or cytologically confirmed mCRPC.
Presence of a deleterious somatic or germline BRCA1 and BRCA2 mutation as confirmed by the central genomics testing laboratory.
Disease status is defined as:
Surgically or medically castrated male patients with metastatic prostate cancer whose disease has progressed following at least one line of androgen receptor (AR) directed therapies or one prior taxane-based chemotherapy (e.g., docetaxel).
Patients with at least one measurable lesion per RECIST 1.1 at baseline that can be accurately assessed by CT or MRI scan and is suitable for repeated assessment at follow-up visits.
ECOG performance status 0 to 2.
Life expectancy of at least 3 months.
Adequate bone marrow, liver, and renal functions as assessed within 7 (± 2) days before the first dose of the study drug.
Patient with vasectomy or patient who agrees to remain completely abstinent or who uses barrier contraceptive measures and agrees to refrain from donating sperm during the entire study treatment period.
Ability to swallow and retain oral medication.
Willingness and capability to comply with the requirements of the study.
|
|
| ExclusionCriteria |
| Details |
Patients with castration-sensitive or non-metastatic castration-resistant prostate cancer
Patients who have had or are receiving anticancer therapy such as chemotherapy, biologic therapy, or any investigational product within 4 weeks or 5 half-lives prior to C1D1, whichever is shorter
Patients who have not recovered from acute toxicities defined as NCI-CTCAE grade greater than 1 of previous therapy except treatment-related alopecia
Prior treatment with a PARP inhibitor such as Olaparib, Rucaparib, Talazoparib, or any other investigational PARP inhibitor
Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery
Patients with symptomatic uncontrolled brain metastasis
HIV-positive patients who are on antiretroviral therapy, or patients with active hepatitis C virus infection or active hepatitis B virus infection
Active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal diseases such as Crohn’s disease or ulcerative colitis
Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure New York Heart Association greater than Class II, unstable angina, or unstable cardiac arrhythmia requiring medication, or clinically relevant findings in the ECG such as second or third-degree AV block, significant prolongation of the QTcF interval unless agreed otherwise between the investigator and the medical monitor
Concurrent disease or condition that would interfere with study participation or safety
Concurrent medications or substances with the potential to affect the activity or pharmacokinetics of RP12146
Symptomatic spinal cord compression unless it is appropriately treated and clinically stable, or impending spinal cord compression unless it is asymptomatic
Patients with other active malignancies at the time of screening with the exception of basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy or whose control may be jeopardized by the complications of this therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Adverse Events (AE), Grade 3/4 AEs, Serious Adverse Events (SAEs), and Dose-limiting toxicities (DLTs),
To determine the Maximum tolerated dose (MTD)/Optimal dose of RP12146
Incidence of drug interruption, dose modification, and drug discontinuation |
28 days for DLT. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall Response Rate (ORR), Duration of Response (DoR), Clinical Benefit Rate (CBR), and Radiographic Progression-Free Survival (rPFS) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Prostate Specific Antigen (PSA) response defined as greater than 50 percent decline from baseline to lowest post-baseline PSA
Pharmacokinetic (PK) parameters of RP12146 |
2 years or till disease progression of last enrolled patients |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
25/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| This is a phase I/Ib, open label, multi-center study in metastatic castration-resistant prostate cancers who have failed at least one line of androgen receptor (AR) directed therapies (e.g., abiraterone acetate, enzalutamide, and apalutamide) or one prior taxane-based chemotherapy (e.g., docetaxel) and have somatic/germline BRCA1/2 mutation. In Phase-I (Dose Escalation) study, optimal dose either 200mg BID or 400mg BID as decided by Data and Safety Monitoring Board (DSMB) based on emerging safety and tolerability data. This will be followed by Phase-I/b (Dose Expansion) study where two parallel expansion groups will receive IP, one with optimal dose and second with one dose lower than optimal dose. In Phase-I, approximately 6-9 patients will be enrolled while in Phase-Ib remaining patients to complete enrollment of 40 patients. Each cycle is of 28 days. Patients will receive IP until disease progression or consent withdrawal, or unacceptable toxicity leading to discontinuation of the patients. Hence duration of participation in this study is variable, and patients will continue in the study until disease progression, unequivocal clinical progression, consent withdrawal, or unacceptable toxicity. | |