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Oxaliplatin Based Chemotherapy

Phase 3

Colorectal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Oct 17, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,053

FDA Designations

No designations recorded

Clinical trial landscape

Oxaliplatin Based Chemotherapy · 1 trial · 1 indication

Phase 3 1
NCT00115765PACCE: Panitumumab Advanced Colorectal Cancer Evaluation StudyColorectal Cancer
COMPLETED1,053 Analytics
PHASE3COMPLETED
PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (Oxaliplatin)
Overall study

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression

Objective Tumor Response Through Week 12 (Irinotecan)
Overall Study

Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum

Secondary Endpoints

Overall Survival (Oxaliplatin)
Overall study
Objective Tumor Response Rate (Oxaliplatin)
Overall study
Time to Progression (Oxaliplatin)
Overall Study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oxaliplatin and bevacizumab without panitumumabACTIVE_COMPARATOROxaliplatin-based chemotherapy and Bevacizumab Q2W alone.
Irinotecan and bevacizumab plus panitumumabEXPERIMENTALIrinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W
Irinotecan and bevacizumab without panitumumabACTIVE_COMPARATORIrinotecan-based chemotherapy and Bevacizumab Q2W alone
Oxaliplatin and bevacizumab plus panitumumabEXPERIMENTALOxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W

Interventions

NameTypeDescription
Oxaliplatin Based ChemotherapyDRUGOxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
PanitumumabDRUGPanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.
Irinotecan Based ChemotherapyDRUGIrinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
BevacizumabDRUGBevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adenocarcinoma of the colon or rectum * Metastatic colorectal cancer (mCRC) * Measurable disease per modified response evaluation criteria in solid tumors (RECIST) criteria * ECOG performance status of 0 or 1 * Available paraffin-embedded tumor tissue (from primary tumor or me...

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