DETECT-01 DETICENE EVALUATION FOR COLORECTAL CANCER THERAPY

Conditions: Metastatic colorectal carcinoma (mCRC) refractory to fluoropyrimidine-,irinotecan-, oxaliplatin- (if KRAS mutated) and panitumumab- or cetuximab- (if KRAS wildtype) containing regimens
MedDRA version: 14.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-002080-21-IT

Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Male or female = 18 years of age;
2. Eastern Cooperative Oncology Group (ECOG) performance status of = 1;
3. Life expectancy of at least 3 months;
4. Understand and voluntarily sign an informed consent form;
5. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma;
6. Measurable disease (RECIST criteria v1.1) using conventional techniques (CT
scan or MRI);
7. Previous treatment including: fluoropyrimidine, oxaliplatin, irinotecan for patients
with mutant KRAS (as assessed in primary tumor or metastases evaluating
codon 12 and 13 mutations) or fluoropyrimidine, oxaliplatin, irinotecan,
cetuximab and/or panitumumab for patients with wild-type KRAS.
8. Imaging confirmed (CT/MRI) disease progression within 3 months of previous
standard treatment. Patients who have been withdrawn from standard treatment
due to unacceptable toxicity will also be allowed into the study. Patients treated
with oxaliplatin in an adjuvant setting should have progressed during or within 6
months of completion of adjuvant therapy;
9. Women of childbearing potential and men must agree to use adequate
contraception since signing of the informed consent form until at least 3 months
after the last study drug administration;
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10. Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements conducted within 7 days of starting study treatment:
· Total bilirubin < 1.5 x the upper limit of normal (ULN);
· Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5 x
ULN (<5 x ULN for patients with liver involvement of their cancer);
· Serum creatinine < 1.5 x the ULN;
· INR/PTT < 1.5 x ULN (patients who are being therapeutically anti-coagulated
with an agent such as warfarin or heparin will be allowed to participate
provided that no prior evidence of underlying abnormality in this parameter
exists. Close monitoring of at least weekly evaluations will be performed until
INR/PTT is stable based on a measurement that is pre-dose as defined by
the local standard of care.);
· Platelet count >100000 /mm3, Hemoglobin (Hb) >9 g/dL, Absolute Neutrophil
Count (ANC) >1500/mm3;
· Alkaline phosphatase limit < 2.5 x ULN (<5 x ULN for patients with liver
involvement by mCRC);
11. Able to adhere to the study visit schedule and other protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Prior treatment with dacarbazine or temozolomide;
2. Previous or concurrent cancer that is distinct in primary site or histology from
colorectal cancer within 5 years prior to randomization EXCEPT for curatively
treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder
tumors [Ta (Non-invasive tumor),Tis (Carcinoma in situ) and T1 (Tumor invades
lamina propria)];
3. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
before start of study medication;
4. Pregnant or breast-feeding patients. Women of childbearing potential must have a
pregnancy test performed a maximum of 7 days before start of treatment, and a
negative result must be documented before start of treatment;
5. Congestive heart failure > New York Heart Association (NYHA) class 2;
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6. Unstable angina (angina symptoms at rest), new-onset angina (begun within the
last 3 months). Myocardial infarction less than 6 months before start of study
medication.
7. Arterial or venous thrombotic or embolic events such as cerebrovascular accident
(including transient ischemic attacks), or pulmonary embolism within the 6 months
before start of study medication;
8. Ongoing infection > grade 2 NCI-CTC version 3.0;
9. Untreated, symptomatic brain metastases (brain radiologic imaging not required);
10. Non-healing wound, ulcer, or bone fracture;
11. Renal failure requiring hemo-or peritoneal dialysis;
12. Substance abuse, medical, psychological or social conditions that may interfere
with the patient’s participation in the study or evaluation of the study results;
13. Known hypersensitivity to any of the study drugs, study drug classes, or excipients
in the formulation.
Investigational Product Dosage and