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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 03:29:57 GMT) CTRI Number CTRI/2010/091/002918 [Registered on: 21/10/2010] - Last Modified On 23/11/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Single Arm Trial Public Title of Study A clinical study to evaluate the safety and efficacy of Endoxifen in metastatic breast cancer patients Scientific Title of AN OPEN LABEL, MULTIPLE DOSE ESCALATING COHORT STUDY TO EVALUATE SAFETY, Study TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ORALLY ADMINISTERED ENDOXIFEN IN METASTATIC BREAST CANCER PATIENTS Secondary IDs if Any Secondary ID Identifier 051-10 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Rajesh CN Trial Coordinator (multi-center study) Designation Asst General Manager Affiliation Address Lambda Therapeutic Research Ltd., Near Gujarat High Court, S.G. Highway, Gota, Ahmadabad GUJARAT 380061 India Phone 079-40202051 Fax 079-40202022 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Praveen Shetty Query) Designation Affiliation NIL Address Lambda Therapeutic Research Ltd., Near Gujarat High Court,S.G. Highway, Gota Ahmadabad GUJARAT 380061 India Phone 079-40202098 Fax 079-40202022 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Rajesh CN Designation Affiliation Address Lambda Therapeutic Research Ltd., Near Gujarat High Court,S.G. Highway, Gota Ahmadabad GUJARAT 380061 India page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 079-40202051 Fax 079-40202022 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Intas Pharmaceuticals Ltd, 2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat, India, Tel. No.: + 91-79-2657-6655, Fax: + 91-79-2657-8862. Primary Sponsor Primary Sponsor Details Name Intas Pharmaceuticals Ltd Address Intas Pharmaceuticals Ltd, 2nd Floor,Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat, India, Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator DrKrishnan Dr. Rai Memorial No. 562, Century Plaza, 09952933735 medical Centre Anna salai, Teynampet-600018 [email protected] Chennai m TAMIL NADU DrKamalaksha Shenoy Kasturba Medical Attavar, 09880167140 College and Hospital Mangalore-575001 Bangalore [email protected] KARNATAKA om Dr SP Shrivastav Lions Cancer Detection New Civil Hospital 09824196710 Centre Campus,Majura Gate,Gujarat, India [email protected] Surat GUJARAT Dr J K Singh Mahavir cancer Pulvarisharif, Patna, 09431021001 sansthan Bihar, 801505 Patna [email protected] BIHAR m Dr Rajnish Nagarkar Manavata Curie Cancer Professional Ethics 02532592666 Center Committee,Opposite Mahamarg Bus [email protected] Stand,Mumbai o.in Naka,422004, Nashik MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Dr Rai Memorail Approved 25/01/2013 No Medical Centre- IRB,Chennai-600018 Institutional Ethics Com Approved 26/02/2011 No mittee,Mangalore-5750 01, Karnataka Mahaver cancer Approved 18/01/2011 No institute and research centre,Patna-801505, page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Bihar Professional Ethics Approved 12/01/2011 No Committee, Manavata Clinical Research Institute,Mumbai Naka, Nasik 422004 Research Independent Approved 29/01/2011 Yes Ethics Committee,223, Meghani Tower, Surat Regulatory Clearance Status Date Status from DCGI Approved/Obtained 15/09/2010 Health Condition / Health Type Condition Problems Studied Patients Malignant neoplasm of breast of unspecified site Intervention / Type Name Details Comparator Agent Intervention Endoxifen Endoxifen Enteric coated Tablets 1mg and 2 mg, Manufactured by Intas Pharmaceuticals Ltd., India. Comparator Agent NIL NIL Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 70.00 Year(s) Gender Female Details 1. The patient willing to give written informed consent to participate in the study before initiating any study related procedures.<br/> 2. Female more than 18 years of age on the day of signing the ICD <br/> 3. Patient with histologically or cytologically confirmed breast cancer before signing of ICD<br/> 4. Patients must have confirmation of inoperable metastatic breast cancer before signing of ICD<br/> 5. The patients should be eligible for third line therapy with resistance to Tamoxifen or Aromatase Inhibitors.<br/> 6. Pt must have negative serum pregnancy test at screening (need not to be performed for postmenopausal women). Exclusion Criteria Exclusion Criteria Details 1.Patient with known history of drug addiction within last 1 year. 2.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis). 3.Patient with history of Thromboembolism or stroke. 4.Known case of HIV infection. 5.Patient with history of ocular disturbances including corneal changes, decrement in color vision perception, retinal vein thrombosis, cataract and retinopathy. 6.Patient with history of endometrial adenocarcinoma, uterine sarcoma or known history of abnormal vaginal bleeding. 7.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints. Method of Generating Other Random Sequence Method of Other Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints To evaluate safety, tolerability and steady state 28 days Pharmacokinetics (PK) of Endoxifen at page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in escalating multiple-dose administered for 28 days in metastatic breast cancer patients Secondary Outcome Outcome Timepoints To evaluate Pharmacodynamics (PD) of 28 days Endoxifen administered for 28 days in metastatic breast cancer patients. Assessment of PD includes improvement in serum estradiol,estrone, and estrone sulfate levels. Target Sample Size Total Sample Size=18 Sample Size from India=18 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 1 Date of First 08/02/2011 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=9 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details NA Brief Summary This is an Open Label, Multiple Dose Escalating Cohort Study To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Orally Administered Endoxifen In Metastatic Breast Cancer Patients. There are 4 cohorts in the study Cohort 1: 2mg tablet of endoxifen once daily for 28 days Cohort 2: 4mg (2 x 2mg) tablet of endoxifen once daily for 28 days Cohort 3: 8mg (4 x 2mg) tablet of endoxifen once daily for 28 days Cohort 0: 1mg tablet of endoxifen once daily for 28 days Cohort 1 will receive 2 mg of Endoxifen once daily for 28 days and if found safe, Cohort 2 will receive 4 mg of Endoxifen once daily for 28 days. If 4 mg dose is found safe, then Cohort 3 will receive 8 mg of Endoxifen. If the Cohort 1 shows toxicity, then Cohort 0 will be administered 1 mg of Endoxifen Rationale for Dose selection Long-term systemic exposures to high levels of Endoxifen are found to be safe in women receiving Tamoxifen therapy. Breast cancer patients have variable capability to metabolize Tamoxifen due to variable function of enzyme cytochrome P450 2D6 (CYP2D6). Studies have shown a clear correlation of specific genetic variant of CYP2D6 with Endoxifen blood levels. The genetic polymorphisms of CYP2D6 have effects on steady-state plasma concentration of Endoxifen in patients receiving Tamoxifen therapy. Recent clinical investigations have shown the correlation with genetic variant of CYP2D6 and breast cancer relapse in early breast cancer patients treated with Tamoxifen. The higher systemic exposure to Endoxifen results in higher clinical efficacy measured as recurrence-free survival Primary objective: To evaluate safety, tolerability and steady state Pharmacokinetics of Endoxifen at escalating multiple-dose administered for 28 days in metastatic breast cancer patients. Secondary Objective: To evaluate Pharmacodynamics of Endoxifen administered for 28 days in metastatic breast cancer patients. Assessment of Pharmacodynamics includes improvement in Ki-67 (cancer proliferation marker) in breast cancer tissue; and serum estradiol, estrone, and estrone sulfate levels. NUMBER OF PATIENTS: Maximum 18 Patients will be enrolled from India. Each Cohort will have 6 patients page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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