Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRC
- Conditions
- Wild-Type KRAS Metastatic Colorectal CancerMedDRA version: 14.0Level: 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
- EUCTR2008-001751-21-BE
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- 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)
-Alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN if liver metastases)
-Bilirubin = 1.5 x ULN
•Magnesium: For subjects presenting with hypomagnesemia, hypomagnesemia must be = Grade 2
-Glycosylated hemoglobin (HgbA1c) of = 8.0%
General
• No history or evidence of thrombosis or vascular ischemic events within the last 12 months before enrollment into part 3, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction.
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 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for thi
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 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
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