None listed
Conditions
Interventions
PRIOR TO STUDY ENTRY, ALL PATIENTS MUST SUBMIT A TUMOR SAMPLE FOR ASSESSMENT OF IGF¬1/IGF-2 LEVELS AND KRAS STATUS. ONLY PATIENTS WHO ARE FOUND TO HAVE HIGH IGF-1/LOW IGF-2 LEVELS AND A WTKRAS GENOTYP
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT HAS METASTATIC COLORECTAL CANCER WHOSE PRIMARY TUMOR ORIGINATED FROM THE RECTUM. 2. PATIENT HAS ARCHIVAL (RECENT OR REMOTE) TUMOR, OR NEWLY OBTAINED FORMALIN-FIXED TISSUE AVAILABLE FOR ANALYSIS FOR BIOMARKER STUDIES. ARCHIVAL SPECIMENS MUST BE TUMOR BLOCK, SURGICAL SPECIMENS OR CORE NEEDLE BIOPSY SPECIMENS. (FINE NEEDLE BIOPSIES ARE NOT ADEQUATE.) PLEASE REFER TO PROCEDURES MANUAL FOR DETAILS ON SAMPLE COLLECTION AND PROCESSING. 3. PATIENT´S TUMOR IS KRAS WILD TYPE AS DETERMINED BY TESTING AT THE PROGRAM CENTRAL LABORATORY DURING THE SCREENING PERIOD AS OUTLINED IN THE DALOTUZUMAB PNO25 ASSAY CHARTER. 4. PATIENT´S WHOSE TUMOR OVER-EXPRESSES IGF-1, DETERMINED BY THE CENTRAL LABORATORY DURING THE SCREENING. THE IGF-1 LEVEL DETERMINATION IS OUTLINED IN THE DALOTUZUMAB PNO25 ASSAY CHARTER. 5. PATIENT HAS AT LEAST ONE MEASURABLE LESION GREATER THAN OR EQUAL TO 15 MM. (REFER TO THE INVESTIGATORS´ IMAGING OPERATIONS MANUAL [WITHIN THE PROCEDURES MANUAL] FOR DETAILED INFORMATION].
Exclusion criteria
Exclusion criteria: 1. PATIENT HAS A MUTANT KRAS (MUTKRAS) METASTATIC RECTAL CANCER DETERMINED BY TESTING AT THE PROGRAM CENTRAL LABORATORY DURING THE SCREENING PERIOD. 2. PATIENT HAS A HIGH IGF-2 EXPRESSING METASTATIC RECTAL CANCER DETERMINED BY TESTING AT THE PROGRAM CENTRAL LABORATORY DURING THE SCREENING. 3. PATIENT IS A KNOWN DIABETIC PATIENT WHO IS POORLY CONTROLLED (HBAL C >8%). 4. PATIENT WHO HAS HAD CHEMOTHERAPY OR BIOLOGICAL THERAPY WITHIN 2 WEEKS PRIOR TO INITIAL DOSING ON THIS STUDY, OR WHOSE TOXICITIES FROM AGENTS ADMINISTERED 2 WEEKS EARLIER HAVE NOT RESOLVED TO AT LEAST GRADE 1 OR BASELINE, OR WHO IS WITHIN 3 WEEKS FROM A PRIOR SURGERY. 5. PATIENT WHO HAS HAD RADIOTHERAPY WITHIN TWO WEEKS PRIOR TO INITIAL DOSING ON THIS STUDY, UNLESS THE RADIOTHERAPY WAS FOR MANAGEMENT OF PAIN. 6. PATIENT IS CURRENTLY PARTICIPATING OR HAS PARTICIPATED IN A STUDY WITH AN INVESTIGATIONAL COMPOUND OR DEVICE WITHIN 30 DAYS OR 5 HALF-LIVES OF THE INVESTIGATIONAL AGENT, WHICHEVER IS LONGER, OF INITIAL DOSING ON THIS STUDY. 7. PATIENT COULD NOT COMPLETE PREVIOUS COURSE OF IRINOTECAN DUE TO INTOLERABLE TOXICITY, OTHER THAN DISCONTINUATION DUE TO FATIGUE FOLLOWING PROLONGED ADMINISTRATION (>4 MONTHS EXPOSURE).
Countries
Belgium, Chile, Denmark, Korea North, New Zealand, Norway, Russian Federation, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactRodolfo Hernan Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed