PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 03:42:49 GMT) CTRI Number CTRI/2014/05/004605 [Registered on: 19/05/2014] - Trial Registered Prospectively Last Modified On 05/02/2015 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group Trial Public Title of Study A clinical trial intended to compare two formulations of Trastuzumab, tablets in patients with metastatic breast cancer. Scientific Title of “A prospective, randomized, multi-centric clinical study to compare Trastuzumab (Test Product, Study Zydus) with Trastuzumab (Reference Product, Roche/Genentech ) in patients with metastatic breast cancer.” Secondary IDs if Any Secondary ID Identifier TRA.12.001.02.1, version 2.1 dated 18 Feb 2014 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Charu Gautam Trial Coordinator (multi-center study) Designation Associate VP – Global Clinical Operation Affiliation Cliantha Research Limited Address Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower,Near Judges Bungalow Road, Bodakdev Ahmadabad GUJARAT 380054 India Phone 07966135655 Fax 07966135641 Email
[email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Charu Gautam Query) Designation Associate VP – Global Clinical Operation Affiliation Cliantha Research Limited Address Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower,Near Judges Bungalow Road, Bodakdev Ahmadabad GUJARAT 380054 India Phone 07966135655 Fax 07966135641 Email
[email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Chirag Shah Designation Head- Clinical Trials Affiliation Cliantha Research Limited Address Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat.