| CTRI Number |
CTRI/2010/091/000034 [Registered on: 04/02/2010] |
| Last Modified On: |
30/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer |
Scientific Title of Study
Modification(s)
|
FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| LF 0207 |
Protocol Number |
| NCT00707304 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
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| Email |
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|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
Quintiles Research (India) Pvt Ltd. |
| Address |
8th Floor, DLF Square
M Block, Jacaranda Marg
DLF City Phase II
Gurgaon, Haryana
India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
Quintiles Research (India) Pvt. Ltd. |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400 059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Agennix Incorporated
Eight Greenway Plaza, Suite 910
Houston, TX 77046 USA
Phone: 713-552-1091
Fax: 713-552-0795
|
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Primary Sponsor
Modification(s)
|
| Name |
Agennix Incorporated |
| Address |
Agennix Incorporated,Eight Greenway Plaza, Suite 910Houston, TX 77046 USAPhone: 713-552-1091Fax: 713-552-0795 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Private Limited |
B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051 |
|
Countries of Recruitment
Modification(s)
|
India
Argentina
Australia
Brazil
Bulgaria
Canada
Colombia
Czech Republic
Germany
Greece
Italy
Latvia
Lithuania
Malaysia
Mexico
Peru
Philippines
Poland
Romania
Russian Federation
Republic of Korea
Singapore
Spain
Taiwan
Turkey
United Kingdom
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. S.V.S.S. Prasad |
Apollo Hospitals, Hyderabad |
Apollo Hospitals, Apollo Health City,Jubilee Hills-500 033
Hyderabad
ANDHRA PRADESH |
+91-40-2360-7777
+91-40-23543270
hydaherf@gmail.com |
| Dr. Lalit Mohan Sharma |
Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur |
Bhagwan Mahaveer Cancer Hospital and Research Centre,Jawahar Lal Nehru Marg-302 017
Jaipur
RAJASTHAN |
+91- 141-2700 10791
+91- 141-2709716
drlalit2003@yahoo.com |
| Dr. Chetan Dilip Deshmukh |
Deenanath Mangeshkar Hospital and Research Centre, Pune |
Deenanath Mangeshkar Hospital & Research Centre,Erandawane-411 004
Pune
MAHARASHTRA |
+91-20-66023025
+91-20-6602025
drchetandeshmukh@rediffmail.com |
| Dr. Venkatesan Srinivasan |
Dr. Kamakshi Memorial Hospital, Chennai |
Dr. Kamakshi Memorial Hospital,No. 1, Radial Road, Pallikarana-600 100
Chennai
TAMIL NADU |
+91- 44-22463282
+91- 44-22463282
vsrinivasan09@gmail.com |
| Dr. Gorijavolu Durga Prasad |
Indo-American Cancer Institute & Research Centre, Hyderabad |
Indo-American Cancer Institute & Research Centre,Road No. 14, Banjara Hills, -500 034
Hyderabad
ANDHRA PRADESH |
+91-40-23551235
+91-40-23542120
durgaoncodr@yahoo.co.uk |
| Dr. Ashish Bakshi |
Kaushalya Medical Foundation Trust Hospital, Mumbai |
Kaushalya Medical Foundation Trust Hospital, Ganeshwadi,Panchpakhadi, Thane-400 601
Mumbai
MAHARASHTRA |
+91-22-25436413
+91-22-25436413
baashish@yahoo.com |
| Dr. P. Ravimohan |
King George Hospital, Visakhapatnam |
Department of Medicine, Andhra Medical College,King George Hospital, New Block, Maharanipeta, -530 002
Visakhapatnam
ANDHRA PRADESH |
+91- 891-2529692
+91- 891-2714644
oncoravi@rediffmail.com |
| Dr. Nalini Kilara |
M S Ramaiah Memorial Hospital, Bangalore |
M S Ramaiah Memorial Hospital, New B E L Road, ,M. S Ramaiah Nagar, MSRIT Post-560 054
Bangalore
KARNATAKA |
+91- 80-40528403
+91-80-40528402
nalini_kilara@yahoo.com |
| Dr. Sachin V. Almel |
P.D. Hinduja National Hospital and Medical Research Centre, Mumbai |
P.D. Hinduja National Hospital & Medical Research Centre,Veer Savarkar Marg, Mahim West-400 016
Mumbai
MAHARASHTRA |
+91-22-24447007
+91-22-24440425
svalmel@yahoo.com |
| Dr. C. D. Sivanandan |
Regional Cancer Centre, Thiruvananthapuram |
Regional Cancer Centre, P.O. Box No. 2417,Medical College Campus -695 001
Thiruvananthapuram
KERALA |
+91-471-2522334
+91-471-2443498
sivanandancd@hotmail.com |
| Dr Mukul Goyal |
SEAROC Cancer Centre, Jaipur |
SEAROC Cancer Centre, S.K. Soni Hospital, ,Sector-5 Vidhyadhar Nagar, Sikar Road-302 013
Jaipur
RAJASTHAN |
91-9530370043
91-141-2233337
drmukulgoyal@yahoo.in |
| Dr. Shailesh Arjun Bondarde |
Shatabdi Hospital, Nashik |
Shatabdi Hospital, Suyojit City Center, ,Opposite Mahamarg Bus Stand, Mumbai Naka-422 005
Nashik
MAHARASHTRA |
+91- 253-2502105
+91- 253-2502105
shaileshbondarde@yahoo.com |
| Dr. Vanita Noronha |
Tata Memorial Hospital, Mumbai |
Tata Memorial Hospital,Dr. E. Borges Road-400 012
Mumbai
MAHARASHTRA |
+91-22- 24177214
+91- 22-24171734
vanita.noronha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethical Review Board, M S Ramaiah Medical College and Teaching Hospital, Bangalore-Dr. Nalini Kilara |
Approved |
| Ethics Committee - Shatabdi Hospital, Nashik-Dr. Shailesh Arjun Bondarde |
Approved |
| Ethics Committee Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur-Dr.Lalit Mohan Sharma |
Approved |
| Ethics Committee, Apollo Hospitals, Hyderabad-Dr.S.V.S.S Prasad |
Approved |
| Human Ethics Committee, Regional Cancer Centre, Trivandrum- Dr. C. D. Sivanandan |
Approved |
| Human Ethics Committee, Tata Memorial Hospital, Mumbai-Dr. Vinita Noronha |
Approved |
| Institutional Ethics Committee - Kaushalya Medical Foundation Trust Hospital, Thane-Dr.Ashish Vijay Bakshi |
Approved |
| Institutional Ethics Committee - King George Hospital, Visakhapatnam-Dr.P Ravi Mohan |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre, Pune-Dr. Chetan Dilip Deshmukh |
Approved |
| Institutional Ethics Committee, Indo-American Cancer Institute & Research Centre, Hyderabad-Dr.G Durga Prasad |
Approved |
| Medical Ethics Committee, Dr. Kamakshi Memorial Hospital, Chennai-Dr. Venkatesan Srinivasan |
Approved |
| National Health & Education Society, P.D. Hinduja National Hospital and Medical Research Centre, Mumbai-Dr.Sachin Almel |
Approved |
| SEAROC Ethics Committee, SEAROC Cancer Centre, Jaipur-Dr.Anish Maru |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Non Small Cell Lung Cancer, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
oral, twice per day |
| Intervention |
Talactoferrin |
oral, 1.5 gm twice per day |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age greater than and equal to 18 yrs
2. Histologically or cytologically confirmed stage IIIB or IV NSCLC
3. Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
4. At least one target lesion that is unirradiated and measurable by RECIST
5. Adequate hematologic, renal and hepatic function
6. ECOG 0, 1, or 2
7. Able to understand and sign an Informed Consent
|
|
| ExclusionCriteria |
| Details |
1. Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
2. Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
3. History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
4. Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
5. Serious active infection
6. Psychiatric illness/ social situations that would limit study compliance
7. Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
8. Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
9. Known HIV positive or on active anti-retroviral therapy
10. Known Hepatitis B surface antigen positive or hepatitis C positive
11. Receipt of any investigational medication within 4 weeks prior to randomization
12. Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
13. Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
14. Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Overall survival |
After the occurrence of the required number of events |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Survival Rate |
Six month and one year |
| Progression free survival |
At time of final analysis |
| Objective response and disease stabilization rate |
At time of final analysis |
| Safety and tolerability |
At time of final analysis |
|
Target Sample Size
Modification(s)
|
Total Sample Size="720"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
03/08/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
18/11/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens. The previous treatment must include a platinum-based chemotherapy. Approximately 720 patients will receive best supportive care (not including any anti-cancer therapy) and be randomly assigned at a ratio of 2:1 to talactoferrin or placebo. Patients would receive the above therapy until the occurrence of progressive disease (PD), start of a next-line therapy for NSCLC, unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first. Safety will be assessed throughout the study by the occurrence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v 3.0, and changes in vital signs, physical examination, and laboratory values. Globally the enrollment target is 720 patients. In India the enrollment target is 200 patients. The tentative date of enrollment of first patient in India is July 15, 2010. |