rectal cancer MedDRA version: 14.1 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
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 PN025 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 PN025 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]. 6. Patient?s disease has progressed after treatment with both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy. Note: Failing oxaliplatin would include failure due to toxicities. Note: Failing irinotecan requires a minimum previous exposure to irinotecan of two cycles. 7. Patient has performance status 0-1 on the ECOG Performance Scale. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 (HbA1c >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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare PFS of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino relative to patients treated with Cetux + Irino;Secondary Objective: To evaluate the ORR of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino compared to patients with Cetux + Irino;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: Screening, Cycle 1/Day 42 (+/- 3days) and every 42 days thereafter until patient progresses | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Response Rate;Timepoint(s) of evaluation of this end point: Screening, Cycle 1/Day 42 (+/- 3days) and every 42 days thereafter until patient progresses | — |
Countries
Australia, Belgium, Brazil, Chile, Denmark, Korea, Democratic People's Republic of, New Zealand, Peru, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactMarta Arias-Salgado
Merck, Sharp & Dohme de España, S.A.
Outcome results
None listed