Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRC
- Conditions
- Wild-Type KRAS Metastatic Colorectal CancerMedDRA version: 16.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-001751-21-GB
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 153
Inclusion Criteria for Parts 1 and 2
Disease related:
-Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
Wild-type KRAS tumor status of archival tumor tissue confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method (see Section 7.1.1 for information on KRAS testing and Section 7.5.1.1 for tumor tissue requirements)
-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 (CT or MRI) or= 10 mm (spiral CT) in one dimension per modified RECIST v1.0 (Appendix F). 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 < 2.0 mg/dL
Hepatic function within the following limits:
-Aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN if liver
metastases)
-Alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN if liver
metastases)
-Bilirubin = 2 x ULN
Magnesium = lower limit of normal
Subjects with known diabetes (Type 1 or 2) must have adequate glycemic
function, as follows:
-Must be controlled with a glycosylated hemoglobin (HgbA1c) of < 8.0%
-Documented fasting blood sugars < 160 mg/dL
Negative pregnancy test = 3 days before enrollment (for woman of childbearing potential only)
Inclusion Criteria for Part 3:
Unless otherwise specified, subjects must meet the following criteria before unblinding in the IVRS may occur (see Section 7.2 for details and time between part 2 and 3).
Disease Related:
•Radiographic evidence of disease progression per modified RECIST v1.0, clinical
progression, or intolerability during treatment (cohort 3 confirmed upon unblinding)
• ECOG 0 or 1
Laboratory:
• Hematologic function within the following limits:
-Hemoglobin = 8 g/dL
-Absolute neutrophil count (ANC) = 1.0 x 10*9 cells/L
-Platelets = 100 x 10*9/L
•Renal function within the following limits:
-Creatinine < 2.0 mg/dL
•Hepatic function within the following limits:
-Aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN if liver metastases)
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 before enrollment
-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 t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method