Wild-Type KRAS Metastatic Colorectal Cancer. --------------------------------------------------------- cáncer colorrectal metastásico con KRAS no mutado MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Trade Name: Vectibix 20mg/ml concentrate for solution for infusion
Product Name: Panitumumab
Product Code: AMG 954
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Panitumumab
Current S
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Parts 1 and 2 Disease related: -Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum. -Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment (see Section 7.5.1.1) -Radiographic evidence of disease progression during or following prior treatment with irinotecan and/or oxaliplatin based chemotherapy for mCRC. -At least 1 uni-dimensionally measurable lesion = 20 mm in one dimension per modified RECIST (Appendix F) using conventional techniques (CT scan or MRI) or spiral CT scan. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to enrollment. All sites of disease must be evaluated. -Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix E) Demographic: -Man or woman = 18 years of age -A life expectancy estimate of = 3 months Laboratory: To be performed = 7 days before enrollment, unless otherwise specified: Hematologic function within the following limits: -Absolute neutrophil count (ANC) = 1.0 x 10*9 cells/L -Platelets = 100 x 10*9/L Renal function within the following limits: -Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria - Parts 1&2 Disease Related: History of prior or concurrent central nervous system (CNS) metastases History of other primary cancer, unless: -Curatively resected non-melanomatous skin cancer -Curatively treated cervical carcinoma in situ -Other primary solid tumor treated with curative intent and no known active disease present for = 5 years before enrollment Medications: -Participation in a phase 3 randomized study of panitumumab in combination with chemotherapy, regardless of treatment assignment -Prior treatment with anti-EGFr inhibitors (eg, panitumumab, cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant setting = 6 months before enrollment -Prior treatment with c-Met, IGF-IR, or IGF-IIR inhibitors -Prior treatment with either AMG 102 or AMG 479 -Use of experimental or approved systemic chemotherapy or radiotherapy = 21 days before enrollment -Use of experimental or approved targeted therapies = 30 days before enrollment -Known allergy or hypersensitivity to any component of panitumumab, AMG 102, or AMG 479 General: -History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan -Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment -Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as = grade 2 per CTCAE version 3.0) -Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion) -Serious or non-healing wound = 35 days before enrollment -Any uncontrolled concurrent illness (eg, infection, bleeding diathesis) or history of any medical condition that may interfere with the interpretation of the study results -Major surgical procedure = 35 days before enrollment or minor surgical procedure = 14 days before enrollment. Subjects must have recovered from surgery related toxicities. Central venous catheter placement, fine needle aspiration, thoracentesis, or paracentesis is not considered a major or minor surgical procedure. -Other investigational procedures or drugs (ie, participation in another clinical study) are excluded = 30 days -Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding -Man or woman of childbearing potential who is not willing to use adequate contraceptive precautions during treatment and for 6 months after the last dose of the last investigational product (men and women). Adequate contraceptive precautions includes double barrier contraceptive methods (eg, diaphragm and condom) or abstinence -Previously enrolled into this study -Subject unwilling or unable to comply with study requirements -Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: To identify a tolerable dose of AMG 102 in combination with panitumumab based on the incidence of dose-limiting toxicities (DLTs) Part 2: To evaluate the efficacy as assessed by the overall objective response rate (ORR) of AMG 102 (tolerable dose selected from part 1) in combination with panitumumab and AMG 479 in combination with panitumumab versus panitumumab alone;Secondary Objective: Part 1: To evaluate the safety of AMG 102 in combination with panitumumab. Pharmacokinetics (PK) exposure of AMG 102 and panitumumab when given in combination. Part 2: To evaluate the safety and efficacy of AMG 102 (tolerable dose selected from part 1) in combination with panitumumab and AMG 479 in combination with panitumumab versus panitumumab alone. • PK exposure of AMG 102 and panitumumab when given in combination • PK exposure of AMG 479 and panitumumab when given in combination • PK exposure of panitumumab when given alone;Primary end point(s): Part 1 – Dose-limiting Toxicity (DLT): Subject incidence of selected adverse and laboratory abnormalities as defined in Section 6.7.1 of the Protocol Part 2 – Overall Objective Response Rate (ORR): The incidence during the treatment phase of either a confirmed CR or PR per modified RECIST criteria (responder). Responses must be confirmed by 2 assessments no less than 28 days apart. All subjects that do not meet the criteria for a confirmed CR or PR by the analysis cut-off date will be considered non-responders | — |
Countries
Austria, Belgium, France, Italy, Spain, United Kingdom
Outcome results
None listed