| CTRI Number |
CTRI/2014/08/004922 [Registered on: 25/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
18/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Folfox and CT-011 in patients with cancer of large intestine. |
|
Scientific Title of Study
|
Phase II study to evaluate the safety, tolerability and efficacy of FOLFOX + CT-011 versus FOLFOX alone administered intravenously to patients with colorectal adenocarcinoma previously untreated for metastatic disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-2008-01,Version 2.0, Amendment 1 dated 21 December 2008. |
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
|
| Name |
Dr Jayashri Krishnan |
| Designation |
Dy Head Operations |
| Affiliation |
Max Neeman Medical International |
| Address |
Max Neeman Medical International, 11 A,TNGO Colony,I Street,Nanganallur, Chennai-600061, India
Kancheepuram
TAMIL NADU
600061
India |
| Phone |
91-9771407484 |
| Fax |
|
| Email |
jayashri.krishnan@maxneeman.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
Max Neeman Medical International |
| Address |
Max Neeman Medical International,
Max House, 1st Floor 1, Dr. Jha Marg,
Okhla Phase-III, New Delhi-110020
South
DELHI
110020
India |
| Phone |
91-9810979215 |
| Fax |
91-11-40548168 |
| Email |
Shariq.Anwar@maxneeman.com |
|
|
Source of Monetary or Material Support
|
| CureTech Ltd., 42 Hayarkon Street Yavne, Israel 81227; Tel: +972-8-9324000; Fax: +972-8-9324001 |
|
|
Primary Sponsor
|
| Name |
CureTech Ltd |
| Address |
42 Hayarkon Street Yavne, Israel 81227 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Max Neeman Medical International |
Max House, 1st Floor, 1, Dr. Jha Marg,
Okhla Phase-III, New Delhi-110020 |
|
|
Countries of Recruitment
|
Bulgaria
India
Peru
Romania
United States of America |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Gupte |
Cancer Clinic, 208, Second Floor |
3 Farm land, Panchsheel Square Shrivardhan Complex,Ramdaspeth, Wardha Road-440012
Nagpur
MAHARASHTRA |
09373107176
0712-2444729
smita_gupte@rediffmail.com |
| Dr Dhananjay Shrikrishna Kelkar |
Deenanath Mangeshkar Hospital and Research Centre |
Surgery OPD Room no D-9, D wing Ground floor,
Deenanath Mangeshkar Hospital and Research Centre,Off Karve Road, Erandawane-411004
Pune
MAHARASHTRA |
91-20-40151000
91-20-25420104
drdsk@hotmail.com |
| Dr Balasubramanian Sivanesan |
G. Kuppuswamy Naidu Memorial Hospital |
Ground floor, VNCC block,
Oncology department, Pappanaickenpalayam- 641037
Coimbatore
TAMIL NADU |
09894744511
91-422-2245756
sivanesan@jipmer.net |
| Dr Minish Jain |
Grant Medical Foundation Ruby Hall Cli nic, 40 Sasoon Road |
OPD room No 2, 3rd Floor,
Grant Medical Foundation, ,Ruby Hall Cli nic, 40 Sasoon Road,-411001
Pune
MAHARASHTRA |
91-9823133390
91-20-26124529
minishjain009@gmail.com |
| DrRakesh Chopra |
Indraprastha Apollo Hospitals |
Oncology OPD room,
Sarita Vihar, Delhi Mathura Road,Sarita Vihar, Delhi Mathura Road-110076
New Delhi
DELHI |
09810034598
011-41677024
rakc1@rediffmail.com |
| Dr Chetna Bakshi |
Kaushalya Medical Foundation Trust Hospital |
OPD room, Cancer doctor,
Ganeshwadi,Panchpakhadi, Behind Nitin Company-400601
Thane
MAHARASHTRA |
09820019550
022-25345292
bakshi109@gmail.com |
| Dr Rajnish Nagarkar |
Manavata Clinical Research Institute |
Ground floor, OPD room,
Opp. Hotel Sandeep,Mahamarg Bus Stand-422004
Mumbai
MAHARASHTRA |
09823061929
0253-2592666
drrajnagarkar@yahoo.co.in |
| Dr Rajesh Kumar Singh |
Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences, |
OPD Room, Ground Floor, Regional Cancer Centre,,Indira Gandhi Institute of Medical Sciences, Sheikhpura,-800014
Patna
BIHAR |
91-9939088899
91-612-2296541
drrajeshsinghigims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics committee on clinical Trials, Indraprasatha Apollo Hospitals, Sarita Vihar, Delhi Mathura Road, New Delhi - 110076, Delhi, India |
Approved |
| Global Health Concern Ethics committee Shrivardhan Complex, Ramdaspeth, Wardha Road, Nagpur-440012, Maharashtra, India |
Approved |
| Indira Gandhi Institute of Medical Sciences, |
Approved |
| Institutional Ethics Committee G. Kuppuswamy Naidu Memorial Hospital, P.B. No. 6327, Pappanaickenpalayam, Coimbatore- 641037, Tamilnadu, India |
Approved |
| Institutional Ethics Committee Kaushalya Medical Foundation Trust Hospital, Ganeshwadi, Panchpakhadi, Behind Nitin Company, Thane(W)-400601, Maharashtra, India |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre, Off Karve Road Erandawane, Pune - 411004, Maharashtra, India |
Approved |
| Institutional Ethics committee, Poona Medical Research Foundation, 40 Sassoon Road, Pune- 411001 |
Approved |
| Manavata Clinical Research Institute, Professional Ethics committee Opp. Hotel Sandeep, Near Mahamarg Bus Stand, Mumbai Naka, Nashik-422004, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with colorectal adenocarcinoma previously untreated for metastatic disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chemotherapy regimens include FOLFOX4 or mFOLFOX6 (5-FU, oxaliplatin |
Humanized monoclonal antibody.
Treatment details similar as of Intervention. |
| Intervention |
CT-011 |
CT-011 (Monoclonal Antibody), 3.0 mg/kg for days 0, 4, 8, 12, 24, 36, 48, 60, 76 along with the combination of FOLFOX .
Dose Value; 3mg/kg (OD).
Frequency: Every 2 weeks
Route: Intravenous
TOTAL duration of therapy: 32 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients age is 18 years or older, both genders.
2. Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
3. ECOG performance status 8804; 1
4. At least 4 weeks from prior major surgery or radiotherapy.
5. Life expectancy greater than 3 months
6. Hematology: ANC 8805; 1.5X109 per Litre; Platelets greater than 100x109 per Litre.
7. Adequate Renal function
8. Adequate Hepatic functions
9. Normal Cardiac function
|
|
| ExclusionCriteria |
| Details |
1. Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
2. Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
3. Patients on concurrent anti cancer therapy other than that allowed in the study.
4. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
5. Presence of clinically apparent or suspected brain metastasis.
6. Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
7. Serious active infection at the time of pre-study screening.
8. Active or history of autoimmune disorders or conditions.
9. Women who are pregnant or lactating
10. Concurrent active malignancy.
11. Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
12. Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
13. Subjects with a condition which may interfere with the subjects ability to understand the requirements of the study.
14. Patients with history of life threatening allergic reactions to food or drugs
15. Patients with symptomatic peripheral neuropathy greater than Grade 1.
16. Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone. [ Time Frame: 32 months ] |
Within 32months following the first CT-011 treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety, tolerability, pharmacokinetics and immunogenicity of CT-011. |
[Time Frame: 32 months ] [Designated as safety issue: Yes] |
| Anti tumor activity of the antibody. |
[Time Frame: 32 months ] [Designated as safety issue: Yes] |
| Objective response rate by RECIST. |
[ Time Frame: 32 months ] [Designated as safety issue: Yes] |
| Progression-free survival rates. |
[Time Frame: 32 months ] Designated as safety issue: Yes] |
| Response duration. |
[Time Frame: 32 months ] [Designated as safety issue: Yes] |
| Overall survival. |
[Time Frame: 32 months ] [Designated as safety issue: Yes] |
| Tumor and immunological markers. |
[Time Frame: 32 months ] [Designated as safety issue: Yes ] |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/08/2009 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3.0 mg/kg in combination with FOLFOX (FOLFOX4 or mFOLFOX6 compared with treatment by FOLFOX alone. Approximately 68 patients are planned to be enrolled to this study at 08 participating sites. This is a global trial including following countries:
Bulgaria
India
Peru
Romania
United States of America |