None listed
Conditions
Interventions
Group 1 Type of group
CT-011 (3.0 mg / kg) plus FOLFOX
Group name:Group 2 Type of group
Folfox will be administered only for 76 weeks.
Sponsors
CureTech Ltd,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • The patient´s age is 18 years or older, of both sexes. • Adenocarcinoma of the colon or rectum confined by histological or cytological study. • Patients with metastatic disease who are eligible for first-line chemotherapy of FOLFOX. An adjuvant or neoadjuvant is allowed to be administered at least 12 months before metastatic disease. • Measurable disease defined by the identification of at least 1 measurable CT lesion according to RECIST criteria. MRI with contrast can be used in situations where CT results are inconsistent with respect to the extent of liver disease. A PET should not be used to assess measurability or response. • ECOG functional status 3 months • Hematology; RAN> 1.5X10 ^ / 1, platelets> 100x10 ^ 9/1. • Adequate renal function creatinine 50cc / min. • Adequate liver functions: bilirubin less than 1.5 mg / dl; (except in patients with Gilbert´s syndrome, who must have a total bilirubin lower than 3.0 mg / dl). AST or ALT <3 x LSN, or <5 x ULN, if liver metastases are known. • Normal cardiac function: There is no active coronary artery disease; there is no Class II, ITI or IV disease of the New York Heart Association; There is no arrhythmia that requires treatment. • Women of childbearing age whose pregnancy tests (urine or blood) show negative results and who commit to using effective contraceptive methods. Reliable contraceptives should be used from the test test and should be continued throughout the study and for at least four months since the last treatment with CT-011. A woman of childbearing age is defined as one who is biologically capable of becoming pregnant. • Men participating in this study should agree to use a form of reliable barrier contraceptives for the duration of the study and for 4 months since the last treatment with CT-011. • Informed consent signed and dated in writing must be obtained to participate in this clinical trial before any study procedure.
Exclusion criteria
Exclusion criteria: • Patients who received adjuvant or neoadjuvant therapy for a non-metastatic disease given in the last 12 months. • Patients who have received oxaliplatin in a period of 12 months before the diagnosis of metastatic disease. • Patients in simultaneous treatment against cancer other than those allowed in the study. • Patients treated with concurrent steroids, other than those authorized for routine antiemetics, or inhaling steroids. • Presence of clinically apparent or suspicious brain metastases. • Patients who have had myocardial infarction, congestive heart failure or significant arrhythmia in the last 6 months. • Serious active infection at the time of the previous review of the study. Conditions requiring antibiotics must be completely resolved and the patient must be without antibiotics before starting the treatment protocol. • Active autoimmune disorders / conditions or a history of having them, including ulcerative colitis or active diverticulitis. Chronic diabetes mellitus, vitiligo or stable hypothyroidism will not be considered exclusion criteria. • Women who are pregnant or breastfeeding. • Concurrent active malignancy. • Ascites, pleural effusion, or osteoblastic bone metastases as the only site of the disease. • Other previous malignant neoplasms, except for non-melanoma cured skin cancer or cervical carcinoma in situ treated curatively or malignant neoplasms properly treated without evidence of activity for more than 5 years. • Patients with a condition that can interfere with the subjects´ ability to understand the study requirements. • Patients with a history of life-threatening allergic reactions to food or medication. • Patients with symptomatic peripheral neuropathy> Grade 1. • Known HIV positive, hepatitis B surface antigen or hepatitis C antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the time from randomization to disease progression or death from any cause. Patients who survive without evaluation of the posterior baseline of the tumor will be censored on Day one; Patients who survive without documented progression at the end of the study or at the time of interruption of the study will be censored at the time of the last evaluation of the tumor. Measure:Progression-free survival in patients with colorectal adenocarcinoma not previously treated for metastatic disease Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:will be evaluated by the RECIST criteria. The overall objective response rate is defined as the proportion of patients who achieved a clinical response of CR or PR. Measure:Emergence of clinical response Timepoints:During the study ; Outcome name:It is defined as the time interval between the date of CR or RP (any state that registers first) on which it was documented and the first date on which the recurrence or progression of the disease (PD) is objectively documented, taking as reference for PD the smallest measurements recorded since the start of treatment. The duration of the stable disease (SD) is defined as the time elapsed from the beginning of the treatment until the criteria for disease progression are reached, having as reference the smallest measurements recorded since the beginning of the treatment. Measure:Response Duration Timepoints:During the study ; Outcome name:It is defined as the time from randomization to the date of death. If a patient is still alive at the time of the analysis, the survival time at the time of the last follow-up is considered. Measure:Global survival Timepoints:During the study | — |
Contacts
Public ContactPilar Garcia
GENEXION S.A.C
Outcome results
None listed