CTRI

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CTRI Number

CTRI/2011/04/001690 [Registered on: 21/04/2011] Trial Registered Prospectively

Last Modified On:

12/02/2013

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A clinical trial to study the effectiveness and safety of Lanreotide injection in patients with carcinoid syndrome. Carcinoid syndrome is a group of symptoms associated with carcinoid tumors,such as diarrhea and/or flushing.

Scientific Title of Study

A double blind, randomized, placebo controlled clinical trial investigating the efficacy and safety of Somatuline Depot (Lanreotide) Injection in the treatment of carcinoid syndrome.

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
2-55-52030-730/TR321	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query
Modification(s)

Name	Naveen Kumar Nandamuri
Designation	Clinical Research Associate
Affiliation	Omnicare Clinical Reserach India Ltd.
Address	Omnicare Clinical Research India Pvt. ltd Omnicare Clinical Research (I) Pvt Ltd HM Towers 1st & 2nd floor, No. 58, Brigade Road Bangalore Karnataka, India Bangalore KARNATAKA 560025 India
Phone	08040650439
Fax	08040650461
Email	naveen.nandamuri@omnicarecr.com

Details of Contact Person
Public Query
Modification(s)

Name	Abhishek Kumar Srivastava
Designation	Clinical Research Associate
Affiliation	Omnicare Clinical Research India Ltd
Address	Omnicare Clinical Research India Pvt. ltd Omnicare Clinical Research (I) Pvt Ltd HM Towers 1st & 2nd floor, No. 58, Brigade Road Bangalore - 560 025, Karnataka, India Bangalore KARNATAKA 560025 India
Phone	08040650455
Fax	08040650461
Email	abhishekkumar.srivastava@omnicarecr.com

Source of Monetary or Material Support

Ipsen Pharma SAS, 65 quai Georges Gorse, 92650 Boulogne Billancourt, Cedex, France.

Primary Sponsor

Name	Ipsen Pharma SAS
Address	65 quai Georges Gorse, 92650 Boulogne Billancourt, Cedex, France
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NIL

Countries of Recruitment

India
Brazil
Croatia
Czech Republic
Israel
Latvia
Poland
Russian Federation
Serbia
South Africa
Turkey
Ukraine
United States of America

Sites of Study
Modification(s)

No of Sites = 13
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Naresh Somani	Bhagwan Mahaveer cancer hospital and research centre	Department of Medical Oncology, Bhagwan Mahaveer cancer hospital and research centre, JLN marg, Malviya Nagar, Jaipur 302017, Rajasthan Jaipur RAJASTHAN	0141-2700107 0141-2709716 drsomani@somexresearch.com
Dr B R Shrivastav	Cancer Hospital & Research Institute	Department of Surgical Oncology, Cancer Hospital & Research Institute, Mandre Ki Mata, Cancer Hills, Gwalior 474009, Madhya Pradesh Gwalior MADHYA PRADESH	751-233650 0751-2336509 br_shrivastav08@yahoo.com
DrRajesh Kumar Grover	Delhi State Cancer Institute	Delhi State Cancer Institute, Dilshad Garden,Delhi-110095 East DELHI	91-11-22110303 91-11-22110505 dsci.delhi@yahoo.co.in
Dr Krishna Mohan MVT	Indo-American Cancer Institute & Research Centre	Indo-American Cancer Institute & Research Centre, Road No-14, Banjara hills, Hyderabad Andhra Pradesh - 500034, India Hyderabad ANDHRA PRADESH	9866154503 04023542120 mvtkm@yahoo.com
Dr Uday Pratap Shahi	Institute of Medical Sciences, Banaras Hindu University, Varanasi	Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, Banaras Hindu University,Lanka, Varanasi-221005, Uttar Pradesh Varanasi UTTAR PRADESH	9450592811 0542-2309367 udayshahi@yahoo.com
Dr S H Advani	Jaslok Hospital & Research Centre	Dept. of Medical Oncology Jaslok Hospital & Research Centre, 15, Dr. G. Deshmukh Marg, Peddar road, Mumbai 400026, Maharashtra, India Mumbai MAHARASHTRA	022-66573232 022-23515880 shadvani2000@yahoo.com
Dr Nirni S Somanath	Omega Hospital	Omega Hospitals, M.L.A. Colony Road No-12, Banjara hills, Hyderabad Andhra Pradesh - 500034, India. Hyderabad ANDHRA PRADESH	9849062003 4023541198 nirni2002@rediffmail.com
Dr Rajesh Kumar Singh	Regional Cancer Centre	Department of Radiotherapy, Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna 800014, Bihar Patna BIHAR	0612-2296541 0612-2296541 drrajeshing238@gmail.com
Dr Rajesh Bhojwani	Santokaba Durlabhji Memorial Hospital and Research Institute	Santokaba Durlabhji Memorial Hospital D-201 Bhawani Singh Marg, Near Rambag Circle, Jaipur-302015 Rajasthan, India Jaipur RAJASTHAN	9829176755 0141-5110209 docbhojwani@gmail.com
Dr Shailesh Bondarde	Shatabdi Super Specialty Hospital	Shatabdi Super Specialty Hospital,Suyojit City Centre, Opp. Mahamarg Bus stand Mumbai naka, Nasik, Maharastra – 422005, India Nashik MAHARASHTRA	0253-2502105 0253-2501888 shaileshbondarde@yahoo.com
Dr Shyam Agarwal	Sir Gangaram Hospital	Department of Medical oncology,Room No: 212 A, Sir Gangaram Hospital, Rajinder Nagar, Delhi 110060 New Delhi DELHI	9811075870 011-25861002 drshyam_aggarwal@yahoo.com
Dr Sandeep Nijhawan	SMS Medical College and Hospital	Department of Gastroenterology, SMS Medical College and Hospital, JLN Marg, Jaipur-302004, Rajasathan, India. Jaipur RAJASTHAN	91-141-2560462 91-141-2575466 drnijhawansandeep@gmail.com
Dr George Karimundackal	Tata Memorial Hospital	Department of Surgical Oncology Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai, Maharastra - 400012, India. Mumbai MAHARASHTRA	22-24177241 2224171734 gkarimundackal@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 12
Name of Committee	Approval Status
Ethics Committee, Jaslok Hospital & Research Centre	Approved
Ethics Committee,Bhagwan Mahaveer cancer hospital and research centre, Jaipur	Approved
Human Ethics Committee, Tata Memorial Hospital, Mumbai	Approved
Institutional Ethics Committee for Human Research, Indo-American Cancer Institute & Research Centre, Hyderabad	Approved
Institutional Ethics Committee Santokaba Durlabhji Memorial Hospital Jaipur	Approved
Institutional Ethics Committee, Sir Gangaram Hospital, Delhi	Approved
Institutional Ethics Committee, Chatrapati Shahuji Maharaj Medical University, Lucknow	Approved
Institutional Ethics Committee,Cancer Hospital & Research Institute, Gwalior	Approved
Institutional Ethics Committee,Institute of Medical Sciences, Banaras Hindu University, Varanasi	Submittted/Under Review
Institutional Ethics Committee,Regional Cancer Centre, Patna, Indira Gandhi Institute of Medical Sciences	Submittted/Under Review
Institutional Ethics Committee,Shatabdi Super Specialty Hospital,Nasik	Approved
MAARG Independent Ethics Committee,Omega Hospitals,Hyderabad	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	Treatment of carcinoid syndrome. Patients with a histopathologically confirmed diagnosis of carcinoid tumor or, a carcinoid tumor of unknown location with liver metastases. ,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Placebo: Saline solution (with an empty 0.5 mL syringe fitted with a 2 cm needle of 1.4 mm external diameter, sealed in a laminated bag)	During the double-blind phase of the study, patients will be randomized in a 1:1 ratio to one of the treatments administered as a deep subcutaneous injection every 4 weeks (± 3 days).
Intervention	•Somatuline Depot / Lanreotide Autogel: 120 mg	During the double-blind phase of the study, patients will be randomized in a 1:1 ratio to one of the treatments administered as a deep subcutaneous injection every 4 weeks (± 3 days).During the open-label phase of the study, all patients will receive: •Somatuline Depot / Lanreotide Autogel 120 mg.Throughout the study, patients will be allowed to use subcutaneous octreotide as needed as rescue medication.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Male or female at least 18 years of age at the time of first dosing 2. Patients must be willing to receive subcutaneous octreotide injections as rescue medication, as needed to control their symptoms, if any. 3. Patients with a histopathologically confirmed diagnosis of carcinoid tumor or, a carcinoid tumor of unknown location with liver metastases (documented biopsy), and a history of carcinoid syndrome (flushing and/or diarrhea) that are either naïve to treatment with an SSTa or responsive (according to the opinion of the Principal Investigator) to conventional doses of LAR (≤ 30 mg every 4 weeks) or to daily doses of ≤ 600 µg of subcutaneous octreotide. 4. Confirmation of positive somatostatin receptor status by SRS (up to 6 months prior to study entry at Screening Visit) 5. Absence of tumor progression documented by two sequential CAT scans or two sequential MRIs (≥ 3 months apart); the last scan/MRI must have been performed within 6 months of study entry (Screening Visit). 6. Patients previously treated with LAR must have received their last dose of LAR at least 4 weeks prior to first dose of study drug (no later than at the Screening Visit).

ExclusionCriteria

Details

1. Patient has a history of known allergy or hypersensitivity to:Investigational drug or any components of its formulationOctreotide.
2. History of carcinoid syndrome refractory to treatment with conventional doses of SSTa.
3. Treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled SSTa and/or tumor debulking 3 months prior to study entry(Screening Visit.
4. History of hepatic arterial embolization, hepatic arterial chemoembolization and/or selective internal radiation therapy (eg. SIR-Spheres) 6 months prior to study entry(Screening Visit).
5. Short bowel syndrome.
6. Uncontrolled diabetes and/or hypertension.
7. Severe renal impairment (glomerular filtration rate 30 mL/min/1.73m2) and/or liver impairment (serum total bilirubin 1.5 mg/dL).
8. Diagnosis of cardiac disease New York Heart Association functional classification Class I. (Patient has limitation of physical activity. Ordinary physical activity causes undue fatigue, palpitation, or dyspnea).
9. Life expectancy less than one year.
10. Any malignancies except:Carcinoid tumor
¡©Basocellular carcinoma of the skin,In situ carcinoma of the cervix,¡Ã 5 years disease free after curative cancer treatment.
11. Any serious medical condition that could jeopardize the safety of the patient and/or the efficacy assessments of the study.
12. Patient is being treated with a Proton Pump Inhibitor (PPI) and has been at a stable dose (no change in dose or frequency of administration) for less than 4 weeks at study entry (Screening Visit).

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Usage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that subcutaneous octreotide is used as rescue medication during the 16-week double-blind phase of the study.	After Baseline.

Secondary Outcome

Outcome	TimePoints
The secondary endpoints are: 1.Frequency of diarrhea events (per day) during the 16-week double-blind phase of the study based on patient IVRS diary records	events (per day).
Frequency of flushing events (per day) during the 16-week double-blind phase of the study based on patient IVRS diary records	events (per day).
Usage of other rescue medications for diarrhea and/or flushing events (e.g., loperamide 2 mg tabs and/or tincture of opium), measured as the percentage of days that the medications were used as rescue medication during the 16 week double-blind phase of the study based on patient IVRS diary records	percentage of days that the medications were used as rescue medication
Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the study	Number of patients who roll over into the open-label phase.
Changes from baseline in Quality of Life (QoL) during the 16-week double blind phase of the study; assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 Carcinoid/NETs module: EORTC QLQ-G.I. NET 21.	Changes from baseline.
Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA) during the 16-week double-blind phase of the study.	changes from baseline in biochemical marker,during the 16-week.
Absolute changes from baseline in biochemical marker - urinary 5 hydroxyindoleacetic acid (5-HIAA) during the 16-week double-blind phase of the study.	changes from baseline in biochemical(5-HIAA) during the 16-week.

Target Sample Size

Total Sample Size="100"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

25/05/2011

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

01/11/2011

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

This, clinical trial to study the effectiveness and safety of Lanreotide injection in patients with carcinoid syndrome, is a global competitive recruitment study. This study will be conducted in India in 12 research centers (Hospitals), DCGI (Health Authority) has given approval to conduct the study on 06 April 2011. Also, this study has received approval from 8 Ethics Committees to carry out the study in their respective study centre’s. (Hospital).

25 patients will be enrolled in the study from India, to meet the global target .The trial expected to start in India by May 2011.