Health Condition 1: null- Patients with colorectal adenocarcinoma previously untreated for metastatic disease
Conditions
Interventions
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
Sponsors
CureTech Ltd
Max Neeman Medical International
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Anti tumor activity of the antibody.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];Overall survival.Timepoint: [Time Frame: 32 months ] [Designated as safety issue: Yes];Progression-free survival rates.Timepoint: [Time Frame: 32 months ] Designated as safety issue: Yes];Response duration.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];Tumor and immunological markers.Timepoint: [Time Frame: 32 months ] [Designated as safety issue: Yes ] | — |
Countries
Bulgaria, India, Peru, Romania, United States of America
Contacts
Public ContactDr Shariq Anwar
Max Neeman Medical International
Outcome results
None listed