| CTRI Number |
CTRI/2015/12/006440 [Registered on: 17/12/2015] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
BIOEQUIVALENCE STUDY OF NILUTAMIDE TABLET, 150 MG WITH NILANDRON (NILUTAMIDE) TABLET, 150 MG IN METASTATIC PROSTATE CANCER PATIENTS UNDER FED CONDITION. |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, MULTIPLE DOSE, CROSSOVER, PIVOTAL, STEADY STATE BIOEQUIVALENCE STUDY OF NILUTAMIDE TABLET, 150 MG MANUFACTURED BY STASON PHARMACEUTICALS, INC. USA WITH NILANDRON (NILUTAMIDE) TABLET, 150 MG OF COVIS PHARMA SARL. USA (acquired by CONCORDIA, USA) IN METASTATIC PROSTATE CANCER PATIENTS UNDER FED CONDITION. |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLCD-098-14, version 1.0 dated 17.02.2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Eswaraiah MD |
| Designation |
Head Regulatory affairs |
| Affiliation |
Syngene International Limited |
| Address |
Syngene International Limited,
Clinical Development
Tower 1 Semicon Park
Electronics City Phase II
Bangalore
KARNATAKA
560100
India |
| Phone |
9945622776 |
| Fax |
|
| Email |
anand.eswaraiah@syngeneintl.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Eswaraiah MD |
| Designation |
Head Regulatory affairs |
| Affiliation |
Syngene International Limited |
| Address |
Syngene International Limited,
Clinical Development
Tower 1 Semicon Park
Electronics City Phase II
Bangalore
KARNATAKA
560100
India |
| Phone |
9945622776 |
| Fax |
|
| Email |
anand.eswaraiah@syngeneintl.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Eswaraiah MD |
| Designation |
Head Regulatory affairs |
| Affiliation |
Syngene International Limited |
| Address |
Syngene International Limited,
Clinical Development
Tower 1 Semicon Park
Electronics City Phase II
Bangalore
KARNATAKA
560100
India |
| Phone |
9945622776 |
| Fax |
|
| Email |
anand.eswaraiah@syngeneintl.com |
|
|
Source of Monetary or Material Support
|
| Stason Pharmaceutical Inc USA |
|
|
Primary Sponsor
|
| Name |
Stason Pharmaceutical Inc |
| Address |
11 Morgan, Irvine, CA 92618, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rishi Grover |
Apple Hospital |
Apple Hospital Udhana Darwaja Surat 39500 Gujarat
Surat
GUJARAT |
09824735922
drrishi.grover@gmail.com |
| Dr Shailesh A Shah |
Bodyline Hospital |
Bodyline Hospital Opposite Annapurna Hall New Vikas Gruh Road Paldi Ahmedabad 7 Gujarat India
Ahmadabad
GUJARAT |
09824035673
shaileshshahuro@yahoo.com |
| Dr Smita Gupte |
Jasleen Hospital |
Jasleen Hospital, Opposite to Big Bazaar, Panchashil Square Dhantoli Nagpur 44001 Maharashtra India
Nagpur
MAHARASHTRA |
0712-2458303
smita_gupte@rediffmail.com |
| Dr Apul Goel |
King George’s Medical University |
King George’s Medical University Chowk Lucknow 226003 Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
09839181465
apul.goel@maxbiosite.in |
| Dr Venugopal Konanki |
Meenakshi Mission Hospital & Research centre |
Lake Are, Melur Road Madurai 625107 Tamil Nadu India
Madurai
TAMIL NADU |
09443058741
konanki9@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Apple Hospital Ethics Committee |
Approved |
| Bodyline Hospitals ethics committee |
Approved |
| Institutional ethics committee Jasleen Hospital |
Approved |
| King Georges medical College |
Submittted/Under Review |
| Meenakshi Mission Hospital & Reseach Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
METASTATIC PROSTATE CANCER, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nilandron (Nilutamide) tablet 150 mg |
Nilandron (Nilutamide) tablet 150 mg of Covis Pharma Sarl USA (acquired by CONCORDIA, USA) |
| Intervention |
Nilutamide Tablet 150 mg |
Nilutamide Tablet 150 mg Manufactured by Stason Pharmaceuticals Inc. USA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients willing to participate by providing written informed consent.
2. Male between 30 to 70 years of age with a histopathologically confirmed metastatic prostate cancer consistent with stage D2 (Stage IV [subtype D2] metastatic prostate cancer).
3. Body mass index of 18–25 kg/m2 (both inclusive).
4. Patients who completed the active run-in period (30 days at 300mg followed by 150 mg once a day as their individual therapy for at least 15 days prior to randomization).
5. Performance status with 0 or 1 as per Eastern Cooperative Oncology Group (ECOG) scale.
6. Life expectancy must be ≥ 6 months.
7. Laboratory values must be as follows:
 White blood cell count: ≥ 3,000/mm3,
 Absolute granulocyte count: ≥ 1,500/mm3
 Platelets: ≥ 100,000/mm3
 Hemoglobin: ≥ 8g/dL
 Serum creatinine:≤ 1.5 x upper limit of normal (ULN)
 Alkaline Phosphatase ≤3 x UNL
 AST: ≤ 3 x ULN
 ALT: ≤3 x ULN
 Serum calcium: ≤ ULN
 Total bilirubin: ≤1.5 x ULN
8. Patient must be willing to provide written informed consent and agree to - use effective contraception while on treatment and for three months after completion of therapy. |
|
| ExclusionCriteria |
| Details |
1. Patients with any pre-planned inpatient hospitalizations for a procedure or elective surgery that would occur during participation in the study.
2. Patients with a history of severe hypersensitivity reaction to nilutamide or any component of this preparation.
3. Patient has received any other investigational agent within 90 days of first day of study drug dosing.
4. Patient has another severe and/or life-threatening medical disease.
5. Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
6. Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation.
7. Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent.
8. Patients with known evidence of brain metastases or carcinomatous meningitis.
9. Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer. Other cured tumors may be entered after discussion with and approval of the study chair.
10. Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
11. Immunocompromised patients (other than that related to the use of corticosteroids) including patients with known HIV infection.
12. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
13. Patients with current peripheral neuropathy of any etiology that is greater than Grade I.
14. Patient with a history of severe hepatic impairment and severe respiratory insufficiency.
15. Prior radiation therapy is allowed; at least 21 days must have elapsed since completion of radiation therapy, and patients must have recovered from side effects.
16. Patients may have received prior surgery; at least 21 days must have elapsed since completion of surgery and patient must have recovered from all side effects.
17. Previous history or evidence of drug abuse in past 10 years
18. Positive serological tests for HIV, Hepatitis B &/or C.
19. Patient who are considered for any reason by the investigator to be inappropriate for study participation.
20. Patient who are not expected to survive for the duration of the study.
21. Refuse to abstain from food for at least 10 h before dosing and for at least 4 h after dose in each period.
22. Refuse to abstain from fluid for at least 1 h before and 1 h after dosing.
23. Patients with documented anti androgen withdrawal syndrome with nilutamide
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate pharmacokinetic bioequivalence of Nilutamide tablet 150 mg manufactured by Stason Pharmaceuticals, Inc., versus Nilandron (Nilutamide) tablet, 150 mg of Covis Pharma Sarl (acquired by CONCORDIA, USA) in Metastatic Prostate Cancer Patients. |
Two 28 days assessment periods i.e. on 56th day assessment will be done. tablet 150 mg manufactured by Stason Pharmaceuticals, Inc., versus Nilandron (Nilutamide) tablet, 150 mg of Covis Pharma Sarl (acquired by CONCORDIA, USA) in Metastatic Prostate Cancer Patients. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of Nilutamide tablets |
During the study period |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2016 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The current study will be a randomized, open label, Two Treatment, multiple dose, crossover, pivotal, steady state bioequivalence study of Nilutamide tablet, 150 mg of Stason Pharmaceuticals, Inc. in metastatic prostate cancer patients |