A clinical trial to study the effects of two drugs, Folfox and CT-011 in patients with cancer of large intestine.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/08/004922
• Date of registration: 25-08-2014
• Prospective Registration: No
• Primary sponsor: CureTech Ltd
• Public title: A clinical trial to study the effects of two drugs, Folfox and CT-011 in patients with cancer of large intestine.
• Scientific title: 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
• Date of first enrolment: 12-08-2009
• Target sample size: 171
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=900
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 2

Countries of recruitment

Bulgaria, India, Peru, Romania, United States of America

Contacts

• Name: Dr Shariq Anwar
• Affiliation: Max Neeman Medical International

• Name: Dr Jayashri Krishnan
• Affiliation: Max Neeman Medical International

Key inclusion & exclusion criteria

Inclusion criteria: 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


Exclusion criteria: 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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients with colorectal adenocarcinoma previously untreated for metastatic disease

Intervention(s)

Intervention1: 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

Control Intervention1: Chemotherapy regimens include FOLFOX4 or mFOLFOX6 (5-FU, oxaliplatin: Humanized monoclonal antibody.

Treatment details similar as of Intervention.

Primary Outcome(s)

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 ]Timepoint: Within 32months following the first CT-011 treatment

Secondary Outcome(s)

Anti tumor activity of the antibody.Timepoint: [Time Frame: 32 months ] [Designated as safety issue: Yes]

Tumor and immunological markers.Timepoint: [Time Frame: 32 months ] [Designated as safety issue: Yes ]

Progression-free survival rates.Timepoint: [Time Frame: 32 months ] Designated as safety issue: Yes]

Safety, tolerability, pharmacokinetics and immunogenicity of CT-011.Timepoint: [Time Frame: 32 months ] [Designated as safety issue: Yes]

Overall survival.Timepoint: [Time Frame: 32 months ] [Designated as safety issue: Yes]

Objective response rate by RECIST.Timepoint: [ Time Frame: 32 months ] [Designated as safety issue: Yes]

Response duration.Timepoint: [Time Frame: 32 months ] [Designated as safety issue: Yes]

Secondary ID(s)

CT-2008-01,Version 2.0, Amendment 1 dated 21 December 2008.

Source(s) of Monetary Support

CureTech Ltd., 42 Hayarkon Street Yavne, Israel 81227; Tel: [phone]; Fax: [phone]

Secondary Sponsor(s)

Max Neeman Medical International

Ethics review

Status: Approved
Approval date: 12/03/2009
Contact:

Global Health Concern Ethics committee Shrivardhan Complex, Ramdaspeth, Wardha Road, Nagpur-440012, Maharashtra, India

Status: Approved
Approval date: 27/04/2009
Contact:

Institutional Ethics Committee Kaushalya Medical Foundation Trust Hospital, Ganeshwadi, Panchpakhadi, Behind Nitin Company, Thane(W)-400601, Maharashtra, India

Status: Approved
Approval date: 28/04/2009
Contact:

Ethics committee on clinical Trials, Indraprasatha Apollo Hospitals, Sarita Vihar, Delhi Mathura Road, New Delhi - 110076, Delhi, India

Status: Approved
Approval date: 03/06/2009
Contact:

Institutional Ethics committee, Poona Medical Research Foundation, 40 Sassoon Road, Pune- 411001

Status: Approved
Approval date: 04/06/2009
Contact:

Indira Gandhi Institute of Medical Sciences,

Status: Approved
Approval date: 10/06/2009
Contact:

Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre, Off Karve Road Erandawane, Pune - 411004, Maharashtra, India

Status: Approved
Approval date: 16/06/2009
Contact:

Institutional Ethics Committee G. Kuppuswamy Naidu Memorial Hospital, P.B. No. 6327, Pappanaickenpalayam, Coimbatore- 641037, Tamilnadu, India

Status: Approved
Approval date: 19/08/2010
Contact:

Manavata Clinical Research Institute, Professional Ethics committee Opp. Hotel Sandeep, Near Mahamarg Bus Stand, Mumbai Naka, Nashik-422004,