A Phase 1b/2 Trial of AMG 655 in Combination with Panitumumab in Subjects with Metastatic Colorectal Cancer
- Conditions
- Colorectal cancer (CRC)MedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastatic
- Registration Number
- EUCTR2007-004722-25-FR
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
Inclusion Criteria
Disease Related
- Histologically or cytologically confirmed metastatic adenocarcinoma of the
colon or rectum
- Radiographically documented disease progression per modified RECIST
during or following treatment with fluoropyrimidine, irinotecan, and/or
oxaliplatin chemotherapy for mCRC. Progressive disease must be
documented during or = 6 months after the last dose of the most recent
chemotherapy regimen prior to enrollment
- At least 1 uni-dimensionally measurable lesion measuring = 20 mm in one
dimension per modified RECIST (Appendix D). 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
- Available archived paraffin-embedded tumor tissue from the primary tumor or
metastasis for submission to the central laboratory (see Section 7.7)
Demographic
- Man or woman = 18 years of age at the time of enrollment
Laboratory (performed = 7 days before enrollment)
- Hematologic function within the following limits:
- Absolute neutrophil count (ANC) > 1.0 x 109 cells/L
- Platelets = 100 x 109/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
- Metabolic function within the following limits:
- Amylase = 2 x ULN
- Lipase = 2 x ULN
- Magnesium = lower limit of normal
- Negative pregnancy test = 72 hours before enrollment (for woman of
childbearing potential only)
Medications
- Subject must have received 1, 2, or 3 prior chemotherapy regimens for
mCRC
Ethical
- Competent to comprehend, sign, and date the IEC/IRB approved written
informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Disease Related
- History of other primary cancer, unless:
- Curatively resected non-melanomatous skin cancer
- Curatively treated cervical carcinoma in situ
- Other primary solid tumor curatively treated with no known active disease
present and no treatment administered for = 5 years before enrollment
Medications
- Prior treatment with anti-EGFr inhibitors (eg, cetuximab, erlotinib, gefitinib),
unless treatment was received in the adjuvant setting = 6 months before
enrollment
- Use of systemic chemotherapy and radiotherapy = 30 days before enrollment
- Use of prior anti-tumor therapies with a short serum half-life (less than
1 week) including prior experimental agents or approved anti-tumor small
molecules = 30 days before enrollment
- Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab)
including prior experimental or approved protein/antibodies = 42 days before
enrollment
- Any investigational agent or therapy = 30 days before enrollment
- Known allergy or hypersensitivity to any component of panitumumab and/or
AMG 655
General
- History of or known presence of central nervous system (CNS) metastases
- 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 = CTC grade 2 [CTCAE version 3.0])
- Known positive test for human immunodeficiency virus (HIV) infection,
hepatitis C virus, acute or chronic hepatitis B infection
- Any co-morbid disease or condition that could increase the risk of toxicity
(eg, significant ascites, significant pleural effusion)
- Any uncontrolled concurrent illness (eg, infection, bleeding) or history of any
medical condition that may interfere with the interpretation of the study results
- Major surgical procedure (requiring general anesthesia) = 28 days or minor
surgical procedure (excluding central venous catheter placement) = 14 days
before enrollment. Subjects must have recovered from surgery related toxicities.
- Other investigational procedures are excluded
- Subject is currently pregnant or breast feeding
- Man or woman of childbearing potential who is not willing to use adequate
contraceptive precautions during treatment and for 6 months (for women) or
1 month (for men) after the last investigational product administration.
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
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