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CTRI Number  CTRI/2022/05/042819 [Registered on: 25/05/2022] Trial Registered Prospectively
Last Modified On: 13/12/2022
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparative bioavailability study of Etoposide Capsules 100 mg in adult patients with platinum resistant or refractory ovarian cancer. 
Scientific Title of Study   A Multicentric, Open Label, Balanced, Randomized, Two-Treatment, Two-Period With Two Consecutive Profile in Single Period, Two-Sequence, Crossover, Multiple Oral Dose, Comparative Bioavailability Study of Etoposide Capsules 100 mg (Intas Pharmaceuticals Limited, India) With Vepesid 100 mg (Etoposide) Soft Capsules (Cheplapharm Arzneimittel GmbH) in Adult Patients With Platinum Resistant or Refractory Ovarian Cancer. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
0463-20 version 1.1 dated 17-Mar-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prashant Modi 
Designation  Sr. General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota

Ahmadabad
GUJARAT
382481
India 
Phone  07940202214  
Fax  07940202021  
Email  prashantmodi@lambda-cro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naman Shah 
Designation  Sr. General Manager 
Affiliation  Lambda Therapeutic Research Ltd. 
Address  Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota

Ahmadabad
GUJARAT
382481
India 
Phone  07940202389  
Fax  07940202021  
Email  namanshah@lambda-cro.com  
 
Details of Contact Person
Public Query
 
Name  Prashant Modi 
Designation  Sr. General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota

Ahmadabad
GUJARAT
382481
India 
Phone  07940202214  
Fax  07940202021  
Email  prashantmodi@lambda-cro.com  
 
Source of Monetary or Material Support  
Intas Pharmaceuticals Limited, Corporate Office Bldg., Near Sola Bridge,S.G. Highway, Thaltej, Ahmedabad-380054, Gujarat, India 
 
Primary Sponsor  
Name  Intas Pharmaceuticals Ltd India 
Address  Intas Pharmaceuticals Limited, Corporate House, Nr. Sola Bridge, S. G. Highway, Thaltej, Ahmedabad – 380 054. Gujarat, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mangesh Korde   Chopda medicare & Research Centre, Meghnam Heart Institute  Department of Clinical Research, Room No. NA, Chopda Medicare & Research Centre Pvt. Ltd Magnum Heart Institute,3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India
Nashik
MAHARASHTRA 
9028532380

drmangeshkorde@yahoo.in 
Dr Ashok Diwan  Dept of Oncology & Radiation Therapy, GMCH  Department of Clinical Research, Room No. NA, Dept. of Oncology & Radiation Therapy,Oncology Government Medical Collage and Hospital Medical Square, GMCH,Nagpur-440003, India
Nagpur
MAHARASHTRA 
9822816608

tinuad76@gmail.com 
Dr K Velavan  Erode Cancer Centre  Department of Clinical Research, Room No. NA, 1/393 Velavan Nagar, Perundurai Road, Thindal, Erode- 638012
Erode
TAMIL NADU 
9842822443

erodecancercentre@gmail.com 
Dr Kunal Jain  GBH Memorial Cancer Hospital  Department of Clinical Research, Room No. NA, American International institute of Medical Science, Near Transport Nagar, Airport Road, Bedwas,Udaipur-313002
Udaipur
RAJASTHAN 
7737667554

drkunaljain.oncology@gmail.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre  Department of Clinical Research, Room No. NA, Behind Shivang Auto, Mumbai Naka, Nashik- 422002
Nashik
MAHARASHTRA 
9823061929

drraj@manavatacancercentre.com 
DrBhushan Wani  Khandesh Cancer Centre  Department of Clinical Research, Room No. NA, 490/3, Surat Bypass Road Surat.
Surat
GUJARAT 
7757930184

kccdhule@gmail.com 
DrShilpa Kandipali  King George Hospital, Andhra Medical Collage  Department of Clinical Research, Room No. NA, Maharani Peta, Opposite Collecter Office Road, Vishakhapatnam-530002.
Visakhapatnam
ANDHRA PRADESH 
9440731463

shilpakandipali@gmail.com 
Dr SP Shrivastav  Kiran Hospital Multi Super Speciality Hospital & Research Centre  Department of Clinical Research, Room No. NA, Near Sumul Diary, Surat- 395004, Gujarat
Surat
GUJARAT 
9824196710

communication@kiranhospital.com 
DrMahesh Kalloli  KLES Dr. Prabhakar Kore Hospital & MRC  Department of Clinical Research, Room No. NA, Nehrunagar, Belgavi- 590010
Belgaum
KARNATAKA 
9945014996

mahesh.kalloli@gmail.com 
Dr Yogesh Anap  Kolhapur Cancer Centre Pvt. Ltd  Department of Clinical Research, Room No. NA, R S 238, Opp Mayur Petrol Pump, Gokul Shirgaon, Kolhapur- 416234
Kolhapur
MAHARASHTRA 
9420635556

yogesh.anap1@gmail.com 
DrViraj Vijay Bongaonkar  Krupamayi Hospitals  Department of Clinical Research, Room No. NA, Akshay, Opp Youth Hostel, Near Baba Petrol Pump Station Road
Aurangabad
MAHARASHTRA 
7972999571

drsushilonco@gmail.com 
Dr B Ravishankar  Omega Hospital  Department of Clinical Research, Room No. NA, Plot No 4, Health City, Chingadili, Hanumanthavaka
Visakhapatnam
ANDHRA PRADESH 
9849123256

dr.bellalaravishankar@gmail.com 
Dr Rachan Shetty  Omega Hospital  Department of Clinical Research, Room No. NA, Mahaveer Circle, Kankanady, Manglore
Bangalore
KARNATAKA 
9008753317

drrachanshetty.medoncology@gmail.com 
Dr Anil Kumar MR  Oncoville Cancer Hospital & Research Centre  Department of Clinical Research, Room No. NA, Nagarbhavi 2nd Stage, Bangalore Number 4 , 80ft road , 7th block, Landmark: near Essential Hospital, Bangalore
Bangalore
KARNATAKA 
9739808502

dranil.onco@gmail.com 
Dr Rakesh Neve  PDEAS Ayurved Rugnalaya and Sterling Multispeciality Hospital  Department of Clinical Research, Room No. NA, Sector No 27, Behind Sweet Junction Pradhikaran, Nigdi Pune Maharashtra - 411044
Pune
MAHARASHTRA 
9881143140

rakesh.neve@gmail.com 
DrAniket Thoke  Sanjeevani CBCC USA Cancer Hospital  Department of Clinical Research, Room No. NA, Sanjeevani CBCC USA Cancer Hospital, Admin Building, 1st floor, Room No 216, Infront of Jain Mandir, Dawada Colony, Pachpedi Naka, Raipur- 492001
Raipur
CHHATTISGARH 
9752929741

drthoke@gmail.com 
DrBhushan Nemade  Sankalp Speciality Hospital  Department of Clinical Research, Room No. NA, Dhanvantari Marg, Vallabh Nagar, Behind Chhan Hotel, Mumbai Agra Highway, Mumbai Naka Nashik-422009, Maharashtra, India
Mumbai
MAHARASHTRA 
9766126162

drbtnemade@yahoo.co.in 
Dr Kartikeya Jain  Shree Himalaya Cancer Hospital & Research Institute  Department of Clinical Research, Room No. NA, 4, Vinod Baug, B/H Railway Station, Jetalpur Bridge, Alkapuri, Vadodara
Vadodara
GUJARAT 
9427432642

dr.kartikeyresearch@gmail.com 
Dr Rajendra Singh Arora  Sujan Surgical Cancer Hospital  Department of Clinical Research, Room No. NA, 52/B, Main Road, Shankar Nagar, Gopal Nagar, Amravati, Maharashtra 444605
Amravati
MAHARASHTRA 
9823097573

dr_rsarara@rediffmail.com 
Dr Ravikumar Wategaonkar  Vedant Multispeciality Hospital  Department of Clinical Research, Room No. NA, GP 83, Opp Rotary Club, Sambhaji Nagar, MIDC, Chinchwad, Pune- 411019
Pune
MAHARASHTRA 
9823602626

drwategaonkar18@gmail.com 
Dr Ravikumar Wategaonkar  Vedant Multispecialty Hospital  Department of Clinical Research, Room No. NA, GP 83, Opp Rotary Club, Sambhaji Nagar, MIDC, Chinchwad, Pune- 411019
Pune
MAHARASHTRA 
9823602626

drwategaonkar18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Amravati Ethics Committee, Dr Rajendra Singh Arora  Approved 
Ethics Committee GBH Memorial Cancer Hospital, Dr. Kunal Jain  Approved 
IEC - Vedant Multispeciality Hospital, Dr. Ravikumar Wategaonkar  Approved 
IEC, Dr K Velavan  Approved 
IEC, KAHER, Dr.Mahesh Kalloli  Approved 
IEC, Oncoville Cancer Hospital & Research Centre, Dr. Anil Kumar  Approved 
Institutional Ethics Committee , Dr.Shilpa Kandipali   Approved 
Institutional Ethics Committee Krupamayi Hospitals, Dr.Viraj Vijay Bongaonkar  Approved 
Institutional Ethics Committee Sterling Multispeciality Hospital, Dr. Rakesh Neve  Approved 
Institutional Ethics Committee, Dr. Ashok Diwan  Approved 
Institutional Ethics Committee, Dr. B Ravishankar  Approved 
Khandesh Cancer Centre Ethical Committee, Dr.Bhushan Wani  Approved 
Kiran Hospital Ethics Committee, Dr. S P Shrivstav  Approved 
Kolhapur Cancer Centre Institutional Ethics Committee, Dr. Yogesh Anap  Approved 
Magna Care Ethics Committee, Dr. Mangesh Korde  Approved 
Manavata Clinical Research Institute Ethics Committee, HCG Manavata Cancer Centre, Dr. Rajnish Nagarkar  Approved 
Navsanjeevani Hospital Ethics Committee, Dr. Bhushan Tapiram Nemade  Approved 
Omega Hospital, Ethical Committee, Dr.Rachan Shetty  Approved 
Sanjeevani Cancer Hospital Ethics Committee, Dr.Aniket Thoke  Approved 
Shree Himalaya Cancer Hospital & Research Institute Ethics Committee, Dr.Kartikeya Jain  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etoposide Capsules 100 mg  Dosage Level(s): Once daily monotherapy, Timing of dosing: Preferably in morning, Route of Administration: Oral, Duration of dosing: 6 days. 
Comparator Agent  Vepesid 100 mg (Etoposide) soft capsules  Dosage Level(s): Once daily monotherapy, Timing of dosing: Preferably in morning, Route of Administration: Oral, Duration of dosing: 6 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Participants are eligible to be included in the study only if all of the following criteria apply:
1. Participant must sign an ICF indicating that she understands the purpose of, and procedures required for the study as described in this protocol and is willing to participate in the study.
2. Participant must be woman, aged greater than 18 years of age, at the time of signing the informed consent.
3. Documented medical history of histo-pathologically or cytologically confirmed diagnosis of epithelial carcinoma of the ovary, fallopian tube cancer or primary peritoneal carcinoma.
4. Documented past medical history of platinum resistant or refractory disease as per standard clinical and Gynecologic Cancer Intergroup Committee (GCIC) criteria: Platinum-resistant disease, defined as disease progression less than or equal to 6 months after completing a platinum-based regimen (3- 6 cycles). Platinum-refractory disease: Lack of response (CR or PR) or disease progression while receiving the platinum-based therapy.
5. Participant who are already receiving and tolerating oral etoposide monotherapy at dose of 100 mg once daily as per the independent clinical judgment of the Investigator for at least one previous cycle (i.e. 21 days treatment in a 28-days cycle).
6. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at screening and baseline.
7. Body mass index (BMI) within the range 18.5 – 30 kg per m2 (inclusive) at screening and baseline.
8. Life expectancy of greater than or equal to 12 weeks at screening and baseline.
9. Participants if have received radiotherapy (regardless of site & dose), a gap of 28 days must be maintained between the last dose of radiotherapy and baseline.
10. Participant with adequate hematologic, liver and renal function at screening and/or baseline as defined in schedule of assessments. Bone marrow function: ANC greater or equal to 1500 per mm3 without granulocyte colony-stimulating factor support at screening and at baseline, Platelet count greater or equal to 100,000 per mm3 without transfusion at screening and at baseline, Hemoglobin greater or equal to 9 g per dL without erythropoietin dependency and without packed red blood cell transfusion at screening and at baseline. Renal function: Creatinine Clearance greater than 50 mL per min as calculated by Cockcroft Gault formula at screening and at baseline. Hepatic function: Bilirubin less than or equal to ULN at screen, ALT, AST, Alkaline phosphatase less or equal to 2.5 times ULN at screening (ALT, AST, Alkaline phosphatase less than or equal to5 times ULN will be allowed in cases where increase is related to liver metastases), Serum Albumin greater than or equal to 3 g per dL at screening.
11. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1% per year), with low user dependency when used consistently and correctly, during the intervention period and for at least 6 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 6 months. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test at screening; and urine pregnancy test before the first dose of study intervention at baseline. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
12. Willing and able to adhere to the lifestyle restrictions specified in this protocol. 
 
ExclusionCriteria 
Details  Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. History of clinically significant medical condition including but not limited to cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances; any severe, acute, or chronic medical, psychiatric or social condition; or laboratory abnormality that as per Investigators opinion may either (a) not be in the best interest of the participant (e.g., compromise the well-being), (b) interfere with the informed consent process and or with compliance with the requirements of the trial, or (c) prevent, limit, or confound the protocol-specified assessments or (d) result in the variation of absorption or metabolism of drug, i.e., ulcerative colitis, or gastrointestinal disease.
2. Known allergies, hypersensitivity, or intolerance to etoposide capsules 100 mg or its excipients (refer to SmPC of Vepesid).
3. Contraindications to the use of etoposide as per SmPC of Vepesid at screening and at baseline.
4. Had major surgery, (e.g., requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 30 days after the last dose of study intervention administration. NOTE: Participants with planned minor surgical procedures to be conducted under local anesthesia may participate.
5. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening.
6. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
7. History of drug abuse within 1 year before screening or positive test result(s) for drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at baseline with exception of drugs prescribed for medical reason.
8. History of alcohol abuse within 1 year before screening or positive test result(s) for alcohol abuse at baseline.
9. Lymphoma, leukemia, or any malignancy within the past 5 years from screening except for malignancy under study, basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
10. Participant s unable to ingest oral medications.
11. Known CNS disease at screening, except for treated asymptomatic CNS metastases, provided all of the following criteria are met: Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla, or spinal cord), No evidence of interim progression or hemorrhage after completion of CNS-directed therapy, No ongoing requirement for corticosteroids as therapy for CNS disease, No stereotactic radiation within 14 days or whole-brain radiation within 28 days prior to randomization.
12. Leptomeningeal disease at screening and baseline.
13. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than or equal to 4 weeks prior to baseline.
14. Documented medical history of any of the following clinically significant cardiac conditions within 6 months of screening: Unstable angina, Myocardial infarction, New York Heart Association (NYHA) cardiac disease (Class II or greater), Unstable arrhythmias, Clinically significant pericardial disease, Electrocardiographic evidence of acute ischemic or active conduction system abnormalities, Any other cardiac illness that could lead to a safety risk to the participant in case of enrolment in the study.
15. Participants requiring dose adjustment from 100 mg established dose during screening period.
16. Received an investigational intervention (including investigational live vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer, before signing the consent or is currently enrolled in an investigational study.
17. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of study intervention for the current study.
18. Uncontrolled blood pressure (BP) with or without antihypertensive medications, defined as systolic greater or equal to 140 mm Hg or diastolic greater or equal to 90 mm Hg at screening.
19. Concomitant use of CYP3A4 inhibitors at baseline or participant who may require prohibited therapies defined in the protocol during the study.
20. Current evidence of tumor lysis syndrome at screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To characterize the pharmacokinetic profile and to compare bioavailability of Etoposide Capsules 100 mg relative to Vepesid 100 mg (Etoposide) soft capsules  12 days.

Following pharmacokinetic parameters will be evaluated, Primary Pharmacokinetic Parameters: Post dose on day 05, day 06 and day 11, day 12: Cmax, ss and AUC0-Tau,ss 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the pharmacokinetic profile of Etoposide Capsules 100 mg relative to Vepesid 100 mg (etoposide) soft capsules  Day 12.

Secondary Pharmacokinetic Parameters:
• Post-dose on day 05, day 06 and day 11, day 12: Tmax,ss, Cav,ss, CTau,ss and %Fluctuation
• Pre-dose on Day 03, 04, 05, 06, 09, 10, 11 and 12: Cpd 
Safety: To compare the safety of Etoposide Capsules 100
mg relative to Vepesid 100 mg (Etoposide) soft capsules. 
Frequency and/or incidence of significant clinical
signs and symptoms, and laboratory abnormalities
during treatment. 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   31/05/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is a multicentric, open label, balanced, randomized, two-treatment, two-period with two consecutive profile in single period, two-sequence, crossover, multiple oral dose, comparative bioavailability study of Etoposide Capsules 100 mg (Test drug from Intas Pharmaceuticals Limited, India)  with Vepesid 100 mg (Etoposide) Soft Capsules (Reference drug from Cheplapharm Arzneimittel GmbH) in adult patients with platinum resistant or refractory ovarian cancer. A target of 58 completers has been kept in this study. The study will be conducted in 2 phases: a 10-day screening phase, and a 12-day open label intervention phase extending from Day 1 (baseline) to Day 13 (EOS). The two-periods of the study will be conducted in two consecutive cycles. There will be no wash out period between two periods. The duration of individual participation will be approximately 23 days.
 
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