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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 06:18:36 GMT)
CTRI Number CTRI/2014/12/005234 [Registered on: 01/12/2014] - Trial Registered Prospectively Last Modified On 03/08/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study A study to assess the efficacy and safety of Fixed Dose Combination of Capecitabine & Cyclophosphamide in patients of Metastatic Breast Cancer Scientific Title of A Prospective, adaptive, randomized, open-Label, multicenter Clinical Trial to assess the efficacy Study and safety of Fixed Dose Combination of Capecitabine & Cyclophosphamide in patients of Metastatic Breast Cancer with failure of Anthracycline and/or taxane chemotherapy Secondary IDs if Any Secondary ID Identifier 471-13, Version 02, 24 Jan 2014, Protocol Number CT-Drugs/38/2014 Details of Principal Details of Principal Investigator Investigator or overall Name Tapan Shah Trial Coordinator (multi-center study) Designation Project 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 382461 India Phone 07940202570 Fax 07940202021 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ravi Alamchandani Query) Designation Assistant 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 382461 India Phone 07940202358 Fax 07940202021 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Tapan Shah Designation Project 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 382461
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India Phone 07940202570 Fax 07940202021 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Intas Pharmaceuticals Ltd. Primary Sponsor Primary Sponsor Details Name Intas Pharmaceuticals Ltd Address 2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad-380009, Gujarat, India Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NA NA Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Jayanti G Patel Apple Hospital Department of Medical 9825121347 Oncology, Udhna Darwaja, Ring [email protected] Road-395002 m Surat GUJARAT Dr Kunjahari Medhi Batra Hospital & Batra Cancer Centre, 1, 9818884856 Medical Research Tughlakabad Centre Institutional Area, [email protected] Mehrauli Badarpur Road-110062 New Delhi DELHI Dr M Gopichand City Cancer Centre 33-25-33, Ch. Venkata 9885256059 Krishnayya Street, Suryarao Pet-520002 [email protected] Krishna m ANDHRA PRADESH Dr Rajnish Vasant Curie Manavata Cancer Opp. Mahamarg, Bus 9823061929 Nagarkar Centre Stand, Mumbai Naka-422004, drraj@manavatacancer Maharashtra centre.com Nashik MAHARASHTRA Dr Venkatesan Dr. Kamakshi Memorial Department of 9841022366 Srinivasan Hospital Pvt. Ltd. Radiation Oncology, No. 1, Radial Road, [email protected] Pallikaranai-600100 om Chennai TAMIL NADU Dr Srinivasan Krishnan Dr. Rai Memorial Head, Clinical 9444896010 Medical Centre Research Department, #526, Century Plaza, [email protected] Anna Salai, Teynampet-600018 Chennai TAMIL NADU
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Dr Mukesh Choudhary Global Abhishek 3-B-III, Near Dharam 9558343663 Cancer Hospital and Singh Circle, Moti Research Centre Doongri Road- 302004 mukeshchoudharydm@ Jaipur gmail.com RAJASTHAN Dr S G Balamurugan Guru Hospital 4/120 F, Pandi Kovil 09486467768 Ring road, Madurai- 625107 [email protected] Madurai TAMIL NADU Dr Pritesh Lohar HCG Cancer Centre Sun Pharma Road, 8080857570 Opp. Satsang Party Plot-390012 [email protected] Vadodara m GUJARAT Dr S Bhattacharyya Health Point 21, Prannath Pandit 9051837235 Multispecialty Hospital street (opp. Lansdowne padmapukur)- 700025 shibashishbhattacharya Kolkata @ymail.com WEST BENGAL Dr Abhishek Kakroo Hemato Oncology 1st Floor Vedanta 9974911291 Clinic Ahmedabad Pvt Institute Of Medical Ltd Sciences, Stadium kakrooabhishek@yaho Road, o.com Navrangpura-380009 Ahmadabad GUJARAT Dr Pramod Patil Kailash Cancer Hospital Muni Seva Ashram, 9427787080 & Research Center Goraj, Waghodia, Vadodara - 391760, pramod.patil@greenash Gujarat, India ram.org Vadodara GUJARAT Dr Rajeev Gupta King George Medical Dept. of Radiotherapy, 7499523800 University (Erstwhile Shahmeena Road, CSMMU) Chowk-226003 drrajeevguptakgmu@ya Lucknow hoo.com UTTAR PRADESH Dr Suresh Babu MC Life Care Hospital Building No. 23/24, Om 9343262589 Complex, 20th Main, Gangothri Circle, BTM suresbabu_mc@yahoo. 1st Stage-560029 co.in Bangalore KARNATAKA Dr G Raja Madras Medical EVR Road, Chennai- 09841107677 College and Rajiv 600003 Gandhi Govt. General Chennai [email protected] Hospital TAMIL NADU Dr Rakesh Reddy Mahatma Gandhi 1/7 MVP 9013355935 Cancer Hospital & Colony-530017 Research Institute Visakhapatnam drrakeshreddyboya@ya ANDHRA PRADESH hoo.com Dr Guruprasad Bhat Mallikatta Neuro Centre Opp. Mallikatta Circle, 9663560802 Kadri, Mangalore-575002 [email protected] Dakshina Kannada n KARNATAKA Dr Rakesh Neve P.D.E.As, Ayurved Sector No. 27, Near 9881143140
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Rugnalaya & Sterling Bhel Chowk, Nigdi, Multispeciality Hospital Pradhikaran, Pune-411 [email protected] 044, Maharashtra, India m Pune MAHARASHTRA Dr Adwaita Gore Prince Aly Khan Hemato Oncology and 9821262618 Hospital Bone Marrow Transplantation, Aga [email protected] Hall, Nesbit Road, Mazagaon-400010 Mumbai MAHARASHTRA Dr Jitendra Kumar S.S. Hospital and Department of 9431021001 Singh Research Centre Radiotherapy, Doctors Colony, Malahi Pakri [email protected] Chowk, om Kankarbagh-800020 Patna BIHAR Dr Shailesh Bondarde Shatabdi Super Suyojit City Center, 9822012427 Speciality Hospital Opp. Mahamarga Bus Stand, Mumbai Naka– shaileshbondarde1971 422005, @gmail.com Nashik MAHARASHTRA Dr Ghanashyam Sparsh Hospitals & Department of Medical 9937500878 Biswas Critical Care Pvt. Ltd. Oncology, A/407,Behind Metro [email protected] Tower, Sahid Nagar-751007 Khordha ORISSA Dr Kuntegowdernn Srinivasam Cancer No. 236/1, Vijayashree 9448055949 Ahalli C Lakshmaiah Care Hospitals India Layout, Arekere, Pvt. Ltd Bannnerghatta Main [email protected] Road-560076 Bangalore KARNATAKA Dr Sudeep Gupta Tata Memorial Centre Tata Memorial Hospital, 02224177201 Dr Ernest Borges Marg, Parel(E)–400012 sudeepgupta04@yahoo Mumbai .com MAHARASHTRA Dr Apurva Patel The Gujarat Cancer M.P. Shah Cancer 07922688419 and Research Institute Hospital, New Civil Hospital Campus, gcri.clinicaltrials@gmail. Asarwa, - 380016 com Ahmadabad GUJARAT Dr Tanveer Mohibbhai Unique Hospital Opp. Kiran Motor, Nr. 9909918887 Maksud Multispecialty & Canal, Civil Hospital Research Institute Char Rasta - Sosyo tanveermaksud@yahoo Circle Lane, Off. Ring .com Road-395002 Surat GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee?
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Institutional Ethics Submittted/Under No Date Specified No Committee, Prince Aly Review Khan Hospital Apple Hospital Ethics Approved 15/12/2014 No Committee, Apple Hospital Dr. Kamakshi Memorial Approved 13/02/2015 No Hospital Institutional Ethics Committee Ethics Committee Guru Approved 29/02/2016 No Hospital,Dr. S. G. Balamurugan Ethics Committee of Approved 11/07/2017 No Care Institute of Medical Sciences Ethics Committee Submittted/Under No Date Specified No Sterling Hospital, Dr. Review Rakesh Neve Ethics Committee, Approved 05/04/2017 No Mahatma Gandhi Cancer Hospital & Research Institute, Dr. Rakesh Reddy Ethics Committee, Approved 18/11/2014 No Unique Hospital Multispecialty & Research Institute GCRI / GCS Ethics Submittted/Under No Date Specified No Committee Review HCG Vadodara Ethics Submittted/Under No Date Specified No Committee Review Health Point Ethics Approved 10/03/2015 No Committee, Health Point Multispecialty Hospital Institutional Ethics Approved 16/01/2015 No Committee Sparsh Hospital Institutional Ethics Submittted/Under No Date Specified No Committee, Dr. Rai Review Memorial Medical Centre (Dr. RMMC-IEC) Institutional Ethics Approved 25/04/2016 No Committee, Madras Medical College, Dr. G. Raja Institutional Ethics Approved 20/04/2015 No Committee, Srinivasam Cancer Care Hospitals Institutional Ethics Approved 11/11/2014 No Committee,City Cancer Centre Institutional Ethics Approved 09/03/2015 No Committee,King George Medical University (Erstwhile CSMMU)
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Institutional Ethics Approved 03/11/2014 No Committee,S.S. Hospital and Research Centre Institutional Ethics Approved 13/04/2018 No Committee,Tata Memorial Centre, Dr Sudeep Gupta Kailash Cancer and Submittted/Under No Date Specified No Medical Centre Review Institutional Ethics Committee, Dr. Pramod Patil Life Care Hospital Approved 01/12/2014 No Institutional Ethics Committee,Life Care Hospital Manavata Clinical Approved 11/12/2014 No Research Institute Ethics Committee,Curie Manavata Cancer Centre Mangala Institutional Approved 22/12/2017 No Ethics Committee, Dr. Guruprasad Scientific Research and Submittted/Under No Date Specified No Ethical Review Review Committee, Batra Hospital & Medical Research Centre Searoc Ethics Submittted/Under No Date Specified No Committee, Soni Review Hospital, Dr. Mukesh Regulatory Clearance Status Date Status from DCGI Approved/Obtained 14/10/2014 Health Condition / Health Type Condition Problems Studied Patients Malignant neoplasm of breast of unspecified site Intervention / Type Name Details Comparator Agent Intervention FDC of Capecitabine & Dose: Group 1: 1400+60 Cyclophosphamide tablet mg/day, Group 2: 1800+80 mg/day, Group 3: 2200+100 mg/day, Frequency: Twice,Mode of Administration: Oral, Duration of treatment: 6 cycles Comparator Agent NA NA Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Female Details 1. The patient willing to give written, signed and dated, informed consent to participate in the study.
2. Female ?18 years and ?65 years of age.
3. Patient must have histopathologically / cytologically confirmed breast cancer.
4. Have at least one measurable lesion as per the RECIST criteria (version 1.1)
5.
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Eastern Cooperative Oncology Group (ECOG) performance status ? 2
6. Left Ventricular Ejection fraction (LVEF) ? 50% as per Echocardiography (ECHO).
7. Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.
8. Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IMP administration
9. Patients with life expectancy of at least 6 months.
10. Serum pregnancy test at screening visit and urine pregnancy test at baseline visit must be negative and agreed to use birth control measured throughout study duration.
11. Patient with adequate bone marrow, renal and hepatic function. Exclusion Criteria Exclusion Criteria Details 1. Patients with known hypersensitivity to capecitabinecyclophosphamide, any excipients of IMPs or with known DPD deficiency. 2. Concurrent chemotherapy or radiation therapy regimens. 3. Patient with clinically significant cardiac conditions: 4. Known History of drug addiction within last 1 year 5. Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 6. Patients who are unwilling or unable to follow protocol requirements. Method of Generating Computer generated randomization Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints • To assess efficacy of FDC of capecitabine and At end of 6 cycles cyclophosphamide in patients with metastatic breast cancer. Secondary Outcome Outcome Timepoints • To evaluate pharmacokinetic profile of First 5 days of cycle 1, Capecitabine and cyclophosphamide. Throughout study period. • To evaluate safety of the patients who are exposed to the investigational medicinal products. Target Sample Size Total Sample Size=216 Sample Size from India=216 Final Enrollment numbers achieved (Total)=166 Final Enrollment numbers achieved (India)=166 Phase of Trial Phase 2/ Phase 3 Date of First 20/12/2014 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India)
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Publication Details NA Brief Summary Metastatic breast cancer (MBC) is incurable and standard therapies provide typically palliation or prolonged symptom free survival. Anthracycline and taxanes are effective agents in advanced breast cancer and prolong survival time, so they are generally considered as the most effective cytotoxic agents for the management of MBC. However, during the past 10 years, approximately one third of patients fail to respond to first-line treatment with anthracycline or taxanes in MBC. Therefore, treating patients with anthracycline-pretreated/resistant MBC represents a significant challenge to oncologists. The combination of capecitabine and cyclophosphamide potentially provides an attractive oral alternative, giving patients more freedom and a sense of control over their treatment. Both cyclophosphamide and capecitabine have demonstrated efficacy in breast cancer in a range of settings. By developing FDC, there is significant improvement expected in patient compliance without compromising efficacy and safety. With this concept, FDC of capecitabine and cyclophosphamide is developed to evaluate efficacy and safety in patient with metastatic breast cancer.
This is an open label randomized multicentre study to evaluate the efficacy and safety profile of FDC. This study will be initiated after obtaining the approvals of Institutional/ Independent Ethics Committee (IEC), clinical trial permission from the Drug Controller General of India (DCGI). The subjects qualifying inclusion and exclusion criteria will be invited to participate in this study. The recruitment will happen as per randomization schedule. Randomization list will be generated by computer generated randomization number. All the Response assessment for the enrolled patients will be based on RECIST Criteria Version 1.1.
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