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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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4 January 2022 |
Main ID: |
EUCTR2006-000170-70-CZ |
Date of registration:
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18/04/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Oxaliplatin/ 5-fluorouracil/ leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ leucovorin Alone in Patients with Previously Untreated Metastatic Colorectal Cancer
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Scientific title:
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A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Oxaliplatin/ 5-fluorouracil/ leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ leucovorin Alone in Patients with Previously Untreated Metastatic Colorectal Cancer |
Date of first enrolment:
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07/06/2006 |
Target sample size:
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1150 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000170-70 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Czech Republic
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Estonia
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Hungary
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Italy
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Latvia
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: • Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in subjects who are presenting with metastatic disease • At least 1 uni-dimensionally measurable lesion of at least 20mm per modified RECIST guidelines (all sites of disease must be evaluated = 28 days prior to randomization) • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 • Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses of EGFr and biomarker testing • Man or woman = 18 years of age • Hematologic function, as follows (= 7 days prior to randomization): o Absolute neutrophil count (ANC) = 1.5 x 109/L o Platelet count = 100 x 109/L o Hemoglobin = 9 g/dL • Renal function, as follows (=7 days prior to randomization): o Estimated creatinine clearance > 50 ml/min • Hepatic function, as follows (=7 days prior to randomization): o Aspartate aminotransferase (AST) = 3 x ULN (if liver metastases = 5 x ULN) o Alanine aminotransferase (ALT) = 3 x ULN (if liver metastases = 5 x ULN) o Total bilirubin = 1.5 x ULN • Metabolic function, as follows (=7 days prior to randomization): o Magnesium = lower limit of normal • Negative pregnancy test = 72 hours prior to randomization (females of childbearing potential only) • Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form • Life expectancy = 3 months 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
Exclusion criteria: • History or known presence of central nervous system (CNS) metastases • History of another primary cancer, except: o Curatively treated in situ cervical cancer, or o Curatively resected non-melanoma skin cancer, or o Other primary solid tumor curatively treated with no known active disease present and no treatment administered for = 5 years before randomization • Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma with the following exceptions: o Subject may have received adjuvant fluoropyrimidine-based chemotherapy if disease progression is documented at least 6 months after completion of chemotherapy o Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization • Prior oxaliplatin therapy • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib) • Any investigational agent or therapy = 30 days prior to randomization • Radiotherapy = 14 days prior to randomization. Subjects must have recovered from all radiotherapy related toxicities • Known allergy or hypersensitivity to platinum-containing medications, 5-FU or leucovorin • Active infection requiring systemic treatment or any uncontrolled infection = 14 days prior to randomization • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year prior to randomization • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan • Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > CTC grade 2 [CTCAE version 3.0]) • Known positive tests 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, dihydropyrimidine deficiency, significant ascites or pleural effusion • Peripheral sensory neuropathy with functional impairment (> CTC grade 3 [CTCAE version 3.0] neuropathy, regardless of causality) • Any uncontrolled concurrent illness 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 prior to randomization. Subjects must have recovered from surgery related toxicities. • Subject who is pregnant or breast feeding • Woman or man of child-bearing potential not consenting to use adequate contraceptive precautions ie. double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 1 month for men • Subject unwilling or unable to comply with study requirements • Previously randomized into this study protocol
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with Previously Untreated Metastatic Colorectal Cancer
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Intervention(s)
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Product Name: Panitumumab Product Code: AMG 954 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Panitumumab Current Sponsor code: AMG 954 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
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Primary Outcome(s)
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Main Objective: To assess whether panitumumab in combination with infusional 5- fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy improves progressionfree survival (PFS) compared to FOLFOX alone as first-line therapy for metastatic colorectal cancer (mCRC) among subjects with wild-type KRAS tumors (subjects whose tumors contain non-mutated KRAS) and subjects with mutant KRAS tumors.
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Secondary Objective: To evaluate overall survival (OS), objective response rate (ORR), duration of response (DOR), time to progression (TTP), and safety and tolerability among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors.
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Primary end point(s): Progression-free survival (PFS)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 07/06/2006
Contact:
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